Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression (COMBAT-SI)
Phase: NA
Conditions: Suicidal Ideation, Treatment-resistant Depression
Sponsor: University of California, San Diego

C ortic al I n hi biti o n as a Bi o m ar ker of Res p o nse i n a C o m p aris o n of Bil ater al Vers us  
U nil ater al Acceler ate d T het a B urst Sti m ul ati o n f or S uici d al I de ati o n i n Tre at me nt - 
Resist a nt De pressi o n ( C O M B A T -SI)  
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U ni versit y of Calif or nia, Sa n Die g o   
C o nse nt t o Act as a Researc h S u bject   
   
C ortic al I n hi biti o n as a Bi o m ar ker of Res p o nse i n a C o m p aris o n of Bil ater al Vers us  
U nil ater al Acceler ate d T het a B urst Sti m ul ati o n f or S uici d al I de ati o n i n Tre at me nt -
Resist a nt  De pressi o n ( C O M B A T -SI)   
 
I ntr o d ucti o n   
 
Dr. C. R. Weiss ma n, Dr. Z.J. Das kala kis, Dr. I. Ha das, a n d Dr. L. G. A p pel b a u m are 
c o n d ucti n g t his researc h a n d as ki n g f or y o ur c o ns e nt t o partici pate. T his secti o n pr o vi des 
a s u m mar y of i m p orta nt i nf or mati o n. T he rest of t he f or m pr o vi des a d diti o nal details.   
 
   
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Researc h is v ol u ntar y - w het her or n ot y o u j oi n is y o ur decisi o n. Y o u ca n disc uss 
y o ur decisi o n wit h ot hers (s uc h as fa mil y a n d frie n ds).   
• 
Y o u ca n sa y y es b ut c ha n ge y o ur mi n d later.   
• 
If y o u sa y n o, w e will n ot h ol d y o ur decisi o n a gai nst y o u.   
• 
Y o ur decisi o n will n ot affect y o ur relati o ns hi p bet wee n y o u a n d U C Sa n Die g o or 
a n y ot her be n efits y o u ma y be e ntitle d t o.   
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Y o u ca n sa y n o e ve n if t h e pers o n i n viti n g y o u is y o ur healt hcare tea m.    
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Please as k q uesti o ns or me nti o n c o ncer ns b ef ore, d uri n g, or after t he res earc h.   
   
T he p ur p ose of t his st u d y is t o deter mi ne t he effects of bilateral accel erate d t heta b urst 
sti m ulati o n (a T B S), a f or m of re petiti ve tra ns cra ni al ma g netic sti m ulati o n (r T M S), o n 
s uici dal i deati o n a n d s uici de pre ve nti o n i n patie nts str u g gli n g wit h diffic ult-t o-treat 
de pressi o n. Partici pati o n i n t his st u d y ma y n ot directl y be nefit y o u b ut ma y res ult i n ne w 
k n o wle d ge t o hel p ot her patie nts i n t he ge neral fiel d of ps yc hiatr y. T his is a si n gle -site 
trial, a n d we ai m t o e nr oll 7 6 partici pa nts at U C S D. Please ta ke t he ti me t o deci de , a n d b e 
s ure t o as k a n y q u esti o ns y o u ma y ha ve. Y o u will u n der g o a n i nitial c o ns ultati o n wit h a 
ps yc hiatrist t o see if y o u are eli gi ble f or t he st u d y. A p pr o priate ps y c hiatric care will be 
pr o vi de d t o y o u w het her y o u c o nti n ue wit h t he st u d y or n ot. Y o ur partici pati o n will last 
a p pr o xi matel y 6 m o nt hs.   
   
T he m ost c o m m o n si de effects of a T B S i ncl u de hea dac h es, scal p disc o mf ort at t he site of 
sti m ulati o n, ti n gli n g, s pas ms or t witc hi n g of facial m uscles, a n d li g ht hea de d ness.   
   
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T he m ost seri o us a d vers e effect d uri n g a T B S is a ge neralize d seiz ure. T he ris k of seiz ure 
is c o m para ble t o t hat of a nti de pressa nt treat me nt a n d occ urs i n less t ha n 0. 1 t o 0. 5 perce nt 
of patie nts w he n safet y g ui deli nes are f oll o w e d.    
   
Al ter nati ves t o t his st u d y ca n i ncl u de me di cati o ns, tal k t hera p y, electr oc o n v ulsi ve 
t hera p y, a n d tr a diti o nal r T M S. Bel o w is a d diti o nal, detaile d i nf or mati o n a b o ut t his 
researc h. Pleas e feel free t o as k q uesti o ns bef ore si g ni n g t his c o nse nt.   
   
W hy h ave y o u bee n as ke d t o p artici p ate, h o w were y o u selecte d, a n d w h at is t he 
a p pr o xi m ate n u m ber of p artici p a nts i n t he st u dy ?    
Y o u ha ve bee n as ke d t o partici pate i n t his st u d y beca use y o u h a ve bee n dia g n ose d wit h 
maj or de pressi ve dis or der ( M D D). We ai m t o e nr oll  7 6 partici pa nts i n t his st u d y. Re petiti ve 
tra nscra ni al ma g netic sti m ulati o n (r T M S) c ha n g es t he el ectrical brai n acti vit y i n maj or 
de pressi ve dis or der ( M D D). W hile k n o w n t o be effecti ve f or M D D, it is u nclear h o w 
effecti ve r T M S is as a tr eat me nt t o treat s uici dal t h o u g hts a n d pre ve nt s ui ci de o verall. A n 
“acceler ate d” f or m of r T M S will als o be use d , c o nsisti n g of 5 da ys wit h 1 0 sessi o ns per 
da y. T his is i nstea d of t he sta n dar d 4 wee ks of treat me nt wit h o nce per da y. T his st u d y will 
l o o k at a state- of-t he-art r T M S pr ot oc ol i n a n atte m pt t o treat s uici dalit y i n t he c o nte xt of 
M D D . It will deter mi ne a brai n -acti vit y si g nat ure t hat   c o ul d hel p select  t he best r T M S 
treat me nt pla n f or a n i n di vi d ual patie nt. T his ma y als o hel p researc h ers better u n dersta n d 
t he p h ysi ol o gical mec ha nis ms (t hi n gs t hat ha p pe n i n y o ur brai n) be hi n d s uici dalit y, w hic h 
w o ul d hel p de vel o p e v e n better treat me nts i n t he f ut ure.   
   
   
W h at will h a p pe n t o y o u i n t his st u dy ? W hic h pr oce d ures are st a n d ar d of c are, a n d 
w hic h are e x peri me nt al ?    
I n a d diti o n t o t he i nf or mati o n at t he be gi n ni n g of t his f or m, here are s o me a d diti o nal 
details a b o ut w hat will ha p pe n t o y o u if y o u a gree t o be i n t his st u d y:   
   
Y o u ma y be r a n d o mize d t o t w o treat me nt c o urses w here t he sti m ulati o n will be a p plie d t o 
y o ur he a d, calle d t he d orsal lateral prefr o ntal c ort e x ( D L P F C). Y o u will eit her recei ve 
acti ve bilater al a T B S o n b ot h si des of y o ur hea d or u nilateral left a T B S treat me nt wit h a 
s ha m or “fa k e” ri g ht-si de sti m ulati o n. S ha m treat me nts are met h o ds use d i n me dical trials 
t o hel p researc hers deter mi ne t he effecti ve ness of a dr u g or treat me nt. T his mea ns t hat if 
y o u are assi g n e d t o t he u nilateral a T B S treat me nt gr o u p, n o sti m ulati o n will be create d o n 
y o ur ri g ht si de , b ut y o u will recei ve acti ve treat me nt at t he left D LP F C. T h ere is n o s ha m 
c o m p o ne nt t o t he bilateral a T B S treat me nt. T heref ore, e ver y o ne i n t he st u d y will recei ve 
a f or m of acti ve treat me nt . Y o ur c ha nce of b ei n g assi g ne d t o eac h gr o u p is 1 i n 2 or 5 0 
perce nt. N eit her y o u n or t he researc h er(s) ca n c h o ose t he  gr o u p t o w hic h y o u will be 
assi g ne d.    
   
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We will als o a d mi nister cli nical assess me nts d uri n g all y o ur visits e xce pt f or t he M RI. 
T hese assess me nts will i ncl u de self -re p ort q uesti o n naires a n d cli nical rater-a d mi nistere d 
q uesti o n naires. T hese q u esti o n naires will assess y o ur m o o d ( M A D R S, H R S D- 1 7, P H Q 9, 
G A D - 7, W H O D A S 2. 0, T he D S M- 5 Le vel 1 Cr oss- C utti n g S y m pt o m Meas ure, a n d 
B H S), s uici dal i deati o n (I N Q, S SI, C S S R S- Lifeti me), a n d me dical hist or y ( MI NI).    
   
   
Tre at m e nt C o urse : t his c o nsists of a cli nical scree ni n g visit, a baseli ne M RI a n d  
ne ur o p h ysi ol o g y visit, 5 c o nsec uti ve da ys of T M S sessi o ns f or 1 wee k, a p ost- treat me nt 
ne ur o p h ysi ol o g y visit, a n d a c o ns ult wit h o ur st u d y ps yc hiatrist 4 wee ks p ost- treat me nt t o 
m o nit or y o ur healt h. We als o pla n t o f oll o w u p o n o verall healt h wit h cli nical 
assess me nts at m o nt hs 1, 3, a n d 6 p ost- treat me nt. T hese pr oce d ures are e x p eri me ntal.   
   
r T M S, a n d s pecificall y t heta b urst sti m ulati o n ( T B S; a hi g h-i nte nsit y versi o n of r T M S  
t hat ta kes less ti me t ha n tra diti o nal r T M S pr ot oc ols b ut uses t he sa me mac hi nes) is a n 
F D A - a p pr o ve d treat me nt t hat is effecti ve f or M D D; it is n ot e x peri me ntal. T here is n ot 
yet a s pecifi c i n dicati o n b y t he F D A f or a n y f or m of r T M S as a treat me nt f or s uici dal 
i deati o n or s uici de pre v e nti o n, t h o u g h. A d diti o nall y, t here is n ot yet a s pecific i n dicati o n 
b y t he F D A f or a n y f or m of accelerate d T B S. If y o u a gree t o b e i n t his st u d y, y o u will g o 
t hr o u g h se ver al e x peri me ntal pr oce d ures: a n accel erate d T B S pr ot oc ol f or treati n g M D D 
a n d s uici dalit y  a n d brai n acti vit y assess me nts t hat tr y t o i de ntif y patter ns ass ociate d wit h 
s uici dalit y, de pressi o n, a n d s y m pt o m i m pr o ve me nt.   
   
T B S: y o ur brai n will be n o n-i n vasi vel y (i.e., o ver t he scal p s urface) sti m ulate d b y 
ma g netic p ulses. F or t his pr oce d ur e, y o u sit o n a c hair a n d will be as k e d t o wear ear pl u gs. 
A n r T M S c oil will be p ositi o ne d o ver t he ri g ht f or bilateral a n d u nilateral treat me nts. 
T he n, t he left fr o nt part of y o ur scal p is o n t o p of y o ur hea d, a n d a re petiti ve sti m ulati o n 
is deli vere d. T he e ntire tr eat me nt pr oce d ure d a y will ta ke a p pr o xi matel y 1 0 h o urs. 
Treat me nt will be a d mi nistere d f or 1 0 mi n utes, wit h a p pr o xi matel y 5 0- mi n ute brea ks. 
Y o u will be a wa k e a n d c o m m u nicate wit h a trai ne d r T M S tec h nicia n t hr o u g h o ut t he 
pr oce d ur e.    
   
M a g netic Res o n a nce I m a gi n g ( M RI) Sc a n: a n M RI uses electr o ma g n etic ra di o wa v es 
i n a str o n g ma g netic fiel d t o ta ke clear pict ures of y o ur brai n. T hes e pict ures will hel p us 
i de ntif y t he precise l o cati o n of t he r T M S sti m ulati o n o n y o ur hea d. Y o u will be as ke d t o 
lie still o n a ta ble i n t he M RI mac hi ne f or 3 0- 4 0 mi n utes d uri n g t he sca n. O ne M RI sca n 
will be c o m plete d i n t his st u d y at t he be gi n ni n g of y o ur T M S treat me nt wee k.   
   
Tr a nscr a ni al m a g netic sti m ul ati o n c o nc urre nt wit h electr oe nce p h al o gr a p h y 
( T M S E E G) ne ur o p h ysi ol ogic al assess me nts: y o ur brai n will be n o n-i n vasi vel y (i.e., 
o ver t he scal p s urface) sti m ulate d b y ma g netic p ulses w hile bei n g rec or de d f or electrical 
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brai n acti vit y. F or t his pr oce d ure, y o u sit o n a c hair a n d will be as ke d t o w ear ear pl u gs. 
Y o u will be fit te d t o wear a n E E G ca p. A T M S c oil will be p ositi o ne d o ver t he E E G ca p 
i n differe nt l ocati o ns, a n d sti m ulati o n will be i nitiate d. T his pr oce d ure is n ot a treat me nt 
b ut a n acc o m p a n yi n g test. Y o u will u n der g o t his test t wice, o nce at t he b e gi n ni n g a n d 
o nce a t t he e n d of t he tr eat me nt p hase of t he st u d y.   
   
   
St u d y Visits a n d Pr oce d ures:    
   
Pr oc e d ur es   
Scr e e ni n g   
Visit 1   
B as eli n e   
r T M S   
Tr e at m e nt   
1 w k  2 w k  
3 w k  
1 m o  3 m o  6 m o  
Visit 2  Visit 3      
I nf or m e d C o ns e nt   
x   
    
    
    
    
 
    
   
   
   
T M S Tr e at m e nt   
   
   
   
x   
   
 
   
   
   
   
M RI   
    
x   
    
    
    
 
    
   
   
   
T M S‐ E E G   
    
    
x   
    
x   
 
   
   
   
   
Cli nic al Ass ess m e nts   
x 
 
x 
x 
x 
x 
x 
x 
x 
x 
   
   
Visit 1 – Scree ni n g Visit – T his visit will i n v ol ve y o ur i nitial e nr oll me nt i nt o t he st u d y 
a n d ca n b e d o ne i n pers o n or virt uall y via I R B-a p pr o ve d platf or ms ( U C S D Healt h Z o o m, 
etc). T his visit will first c o nsist of re vie wi n g a n d si g ni n g t he c o nse nt f or m. If d o ne 
virt uall y, i nf or me d c o nse nt si g nat ures will be o btai ne d o nli ne via U C S D D oc u Si g n.  
After c o ns e nti n g, y o u will c o m plete f or ms a n d cli nical q uesti o n naires ( M A D R S, S SI, 
H A M D - 1 7, C-S S R S, P H Q - 9, B H S, I N Q, a n d t he D S M- 5 Le vel 1 Cr oss- C utti n g 
S y m pt o m Meas ure wit h a researc h c o or di nat or. T hese q uesti o n naires will assess y o ur 
be ha vi or a n d e m oti o ns. Partici pa nts of c hil d- b eari n g p ote ntial will be as ke d t o attest t hat 
t he y are n ot pr e g na nt at t he scree ni n g visit a n d t he M RI visit t o r ule o ut pre g na nc y. T his 
is d oc u me nte d o n t h e Tra nscra ni al Ma g netic Sti m ulati o n A d ult Safet y Scree n ( T A S S) 
safet y f or m. Partici pa nts will als o be as ke d q uesti o ns a b o ut t he c urre nt met h o d of birt h 
c o ntr ol t o e ns ure t he y h a ve a n a d e q uate met h o d t o pre ve nt pre g na nc y t hr o u g h o ut t he trial. 
A d diti o nall y, d uri n g t his visit a n d/ or o n t he first da y of treat me nt, y o u ma y c o m plete a 
bilateral resti n g m ot or t hres h ol d ( R M T). T his pr o ce d ure c o nsists of placi n g a T M S c oil 
o n y o ur hea d n ear y o ur m ot or c orte x a n d se n di n g ma g netic p ulses wit h a T M S c oil t o 
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deter mi ne t he mi ni m u m i nte nsit y t hat e v o kes a m ot or res p o nse i n y o ur a b d u ct or p ollicis 
bre vis ( A P B) m uscle o n y o ur t h u m b. T his pr oce d ure is n ot mea nt t o ha ve a n y t hera p e utic 
effect a n d is d o ne t o deter mi ne treat me nt d osi n g. T his visit will ta ke 3 - 4 h o urs.    
   
B el o w ar e s e cti o n s f or virt u al c o n s e nt o nl y:   
Calif or nia la w pr o vi des s pecific ri g hts w he n y o u are as ke d t o pr o vi de electr o nic c o nse nt:   
• Y o u ha ve t he ri g ht t o o btai n a c o p y of t he c o nse nt d oc u me nt i n a n o n- electr o nic f or mat.   
• Y o u ha ve t he ri g ht t o pr o vi de c o nse nt i n a n o n- electr o nic f or mat.   
• If y o u c ha n g e y o ur mi n d a b o ut electr o nic c o nse nt, y o u ha ve t he ri g ht t o re q uest t hat it be 
wit h dra w n . Y o u ca n t he n pr o vi de c o nse nt i n a n o n-electr o ni c f or mat; h o w e ver, a c o p y 
of y o ur electr o nic c o ns e nt will be mai ntai ne d f or re g ulat or y p ur p oses. Pleas e c o ntact t he 
st u d y tea m if y o u wis h t o wit h dra w y o ur el ectr o ni c c o nse nt.   
T his a gree me nt f or electr o n ic c o nse nt a p plies o nl y t o y o ur c o nse nt t o partici pate i n t his 
researc h st u d y.  
I n di vi d uals of C hil d beari n g P ote ntial:   
   
If y o u ar e a w o ma n w h o ca n bec o me pre g n a nt, it is e x pecte d t hat y o u will use a n 
effecti ve met h o d of birt h c o ntr ol t o pre ve nt e x p osi n g a fet us t o a p ote ntiall y da n ger o us 
a ge nt wit h u n k n o w n ris k. If y o u ar e pre g n a nt or c urre ntl y breastfee di n g, y o u ma y n ot 
partici pate i n t his st u d y. Y o u u n dersta n d t hat if y o u are pre g na nt, if y o u bec o me pre g na nt, 
or if y o u are breastfee di n g d uri n g t his st u d y, y o u or y o ur c hil d ma y be e x p ose d t o a n 
u n k n o w n ris k.   
   
Bef ore be gi n ni n g t his res earc h st u d y, y o u will be as ke d t o attest t hat y o u are n ot pre g na nt. 
Y o u m ust a gree t o a v oi d se x ual i nterc o urs e or use a birt h c o ntr ol met h o d j u d ge d t o be 
effecti ve b y t he i n vesti gat or a n d w hic h will n ot i nterfere wit h t he pr o p os e d i n vesti gati o n. 
Y o u m ust acce pt t he ris k t hat pre g na nc y c o ul d still res ult des pite t he res p o nsi ble use of 
relia ble met h o ds of birt h c o ntr ol. Y o u a gree t o n otif y t he i n vesti gat or as s o o n as p ossi ble 
of a n y fail ur e of pr o p er use of y o ur birt h c o ntr ol met h o d or if y o u bec o me pre g na nt, 
eit her of w hic h m a y res ult i n y o ur bei n g wit h dra w n fr o m t he st u d y.   
   
If y o u miss a peri o d or t hi n k y o u mi g ht be pre g na nt d uri n g t he st u d y, y o u m ust tell t he 
st u d y d oct or i m me diatel y. If y o u bec o m e pre g n a nt, y o u m ust st o p ta ki n g part i n t he 
st u d y.    
   
   
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Visit 2 –  B aseli ne Visit  - Y o u will be sc he d ule d f or a 1- h o ur M R i ma gi n g sessi o n at t he  
U C  Sa n Die g o Ce nter f or F u ncti o nal M RI ( 9 5 0 0 Gil ma n Dri ve, La J olla, C A 9 2 0 9 3, M C 
0 6 7 7). T he M RI ma y n ot be a p pr o pri ate if y o u ha ve/ ha d a n y metal -c o ntai ni n g i m pla nt, 
s uc h as car diac p ace m a k er, heart val ve re place me nt, ve n o us u m brella or filter, a ne ur ys m 
s ur ger y, i ntracra nial b y p ass, re nal or a ortic cli ps, j oi nt re place me nts, s h u nts/ste nts, metal 
mes h/c oil i m pla nts, metal mes h/c oil i m pla nts, metal plates/ pi ns/scre ws/ wires or a n y ot her 
metal i m pla nts, ne ur osti m ulat or, i ns uli n p u m p, pr ost hetic de vices s uc h as mi d dle ear e y e 
j oi nt or pe nile i m pla nts, I. U. D, per ma n e nt e yeli ner or e ye br o ws, metal fra g me nts i n e yes, 
s ki n, or b o d y, bee n e m pl o ye d as s heet- m etal w or k er or w el der, are pre g na nt or tr yi n g t o 
get pre g na nt. H eari n g ai ds m ust be re m o ve d as w ell. D uri n g t he sca n ni n g sessi o n, y o u 
will be place d i n a lar ge d o n ut- li ke mac hi ne calle d a ma g netic res o na nce s ca n ner. Y o u 
m ust be a ble t o lie still, flat o n y o ur bac k f or 1 h o ur. Y o ur hea d will be i nsi de a hel met -
li ke str uct ure, a n d p a d di n g will be place d t o c us hi o n y o ur hea d a n d re d u ce m oti o n. W hile 
n o o ne will be i n t he sca n ner r o o m wit h y o u d uri n g t he sessi o n, y o u will re mai n i n direct 
ver bal c o ntact wit h t he M RI tec h nicia n via i nterc o m  a n d ma y s q ueeze a b ul b place d i n 
y o ur ha n d, w hic h will all o w y o u t o s o u n d a n alar m if y o u ha ve a n y c o n cer ns or w o ul d 
li ke t o st o p.    
   
   
Visit  3 – B aseli ne Visit – T he visit will be gi n wit h t h e H R S D‐1 7,  S SI, G A D‐7, W H O D A S 
2. 0, a n d M A D R S c o m pl et e d wit h t h e r es e arc h c o or di n at or. O ur tea m will deter mi ne t he 
sti m ulati o n le vel f or T M S p ulses as a c o m p o ne nt of t he T M S-E E G meas ures . T he 
researc hers will m o ve t he i nte nsit y of t he sti m ulati o n u ntil it ca uses eit her y o ur t h u m b or 
fi n ger t o t witc h ( w he n t h e c oil is place d o ver t he p art of t he brai n c o ntr olli n g m o ve me nt 
o n t he ot her si de of t he b o d y), als o calle d resti n g m ot or t hres h ol d ( R M T). T his cali brati o n 
is d o ne t o e ns ure t hat s ufficie nt sti m ulati o n i nte nsit y is use d f or eac h i n di vi d ual wit h o ut 
e xcessi ve sti m ulati o n. T he T M S E E G sessi o n will assess brai n p h ysi ol o g y b y sti m ulati n g 
t he brai n usi n g T M S si m ulta ne o us wit h E E G rec or di n gs. T hese sessi o ns will ta ke place at 
t he D o ve Ca n y o n cli nic a n d will ta ke 3- 4 h o urs. Li ke  t he M RI, T M S mi g ht n ot be 
a p pr o priate if y o u h a ve a n y ma g netic-se nsiti ve metal i n y o ur hea d.  O bjects t hat ma y 
ha ve t his ki n d of m etal i ncl u de:   
 •    A ne ur ys m cli ps or c oils    
• 
Car oti d or cer e bral ste nts    
• 
I m pla nte d sti m ulat ors    
• 
Electr o des t o m o nit or y o ur brai n acti vit y    
• 
Ferr o ma g netic i m pla nts i n y o ur ears or e yes    
• 
B ullet or s hra p nel fr a g me nts    
• 
Ot her metal de vices or o bjec ts i m pla nte d i n t he hea d, s uc h as i m pla nte d h eari n g ai ds    
• 
Pellets, b ullets, or metallic fra g m e nts    
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
7  
Y o u s h o ul d be a ware t hat t he ma g netic fiel ds ge n erate d b y t he sti m ulat or ma y da ma ge 
ma g netic car ds, watc h es , a n d s o me electrical de vi ces.  Please re m o ve a n y s uc h ite ms 
bef ore t esti n g. A p h ysicia n a n d res earc h assista nt will re vie w t his wit h y o u d uri n g y o ur 
i nitial visit.   
D uri n g t he T M S- E E G sessi o n:   
• 
Y o u will be seate d i n a c o mf orta ble c h air a n d w ear a n E E G ca p a n d a ne ur o na vi gati o n 
hea d stra p. A m a g netic c oil will be hel d o n t he s urface of y o ur scal p.   
• 
W he n t he ma g n etic sti m ulati o n is a p plie d, y o u will feel a t witc h or li g ht ta p pi n g o n 
t he s urface of y o ur scal p. T he sti m ulati o n is n ot pai nf ul a n d lasts a s h ort ti me.   
• 
Y o u will als o  hear a clic ki n g n oise. We will pr o vi de y o u wit h ear pl u gs f or y o ur 
c o mf ort a n d pr otecti o n.   
T here will als o be a si milar 2 t o 3 - h o ur T M S - E E G visit p ost-treat me nt. Cli nical 
assess me nts will als o be c ollecte d d uri n g t his visit.   
   
Tre at m e nt visits – Y o u will arri ve at t he D o v e Ca n y o n site i n t he m or ni n g f or 5 
c o nsec uti ve da ys, M o n d a y t hr o u g h Fri da y. Y o u will c o m plete s h ort scree ni n g cl i nical 
q uesti o n naires wit h assista nce fr o m t he res earc h assista nt a n d r T M S tec h nicia n. Y o u will 
als o c o m plete a n acti ve/ place b o r ati n g s ur ve y c o nsisti n g of o ne q uesti o n a d dressi n g 
w het her y o u b elie ve t he ri g ht si de is acti ve or place b o (s ha m) at t he e n d of t he first 
sessi o n a n d t he e n d of t h e last sessi o n. D uri n g treat me nt, y o u will sit i n a c o mf orta ble 
c hair, a p pl y o ver-t he- c o u nter t o pical Li d ocai ne ( 4 % stre n gt h) o n y o ur f ore hea d, a n d w ear 
ear b u ds t o mi ni mize heari n g da ma ge. Li d ocai n e re d uces  t he se ns ati o n of T M S a n d ma ke s 
t he treat me nt m ore c o mf orta ble. A n r T M S c oil will be p ositi o ne d o ver y o ur scal p, a n d 
re petiti ve sti m ulati o n will be i nitiate d f or 1 0 mi n utes. It will be s pace d o ut wit h a brea k 
a p pr o xi matel y 5 0 mi n utes fr o m eac h ot h er, f or at l east 1 0 h o u rs dail y. After t he 
sti m ulati o n sessi o n, y o u will rest i n a desi g nate d r o o m. Please n ote t hat y o u s h o ul d bri n g 
l u nc h, s nac ks, or ot her ite ms f or e ntertai n me nt, i ncl u di n g tec h n ol o g y (cell 
p h o nes/ta blets), d uri n g y o ur treat me nt da y. We will n ot pr o vi de meals. H o we ver, y o u are 
welc o me t o visit  o ne of t he l ocal rest a ura nts/ gr ocer y st ores near o ur cli nic. A st u d y 
p h ysicia n trai ne d i n r T M S treat me nt will be a vaila ble o nsite t hr o u g h o ut y o ur treat me nt 
c o urse.   
   
Visit 1 wee k aft er t re at m e nt – A  p ost- treat me nt T M S- E E G sessi o n f or brai n p h ysi ol o g y 
assess me nt at D o ve Ca n y o n Cli nic. T his visit will be i de ntical t o visit 3 a n d will occ ur 
a b o ut 1 wee k after t h e e n d of y o ur treat me nt. A d diti o nall y, y o u will be as ke d t o c o m plete 
cli nical q uesti o n naires. T his visit will ta ke 3 t o 4 h o urs.    
   
   
Visits 2 wee ks – 6 m o nt hs after t re at me nt – 2 w ee ks, 3 wee ks, 1 m o nt h, 3 m o nt hs, a n d 
6 m o nt hs after treat me nt, y o u will c o m plete a 1 -h o ur cli nical assess me nt. T hese visits ca n 
be ma de i n pers o n at t he D o ve Ca n y o n Cli nic or re m otel y via I R B -a p pr o ve d platf or ms 
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
8  
( U C S D Healt h Z o o m, etc.). D uri n g t his assess me nt, y o u will a ns wer cli nical 
q uesti o n naires. D uri n g t h e 1- m o nt h p ost- treat me nt f oll o w- u p visit, y o u will ha ve a 
sc he d ule d f oll o w- u p visit wit h t he st u d y p h ysicia n i n a d diti o n t o t he cli nical assess me nts. 
D uri n g t his ps yc hiatrist c o ns ult, t he p h ysicia n will assess y o ur m o o d a n d w ell - bei n g.   
   
T hr o u g h o ut t he st u d y, t he st u d y ps yc hiatrist will m o nit or y o u, a nd y o u ca n re q uest 
t o meet wit h t he researc h ps yc hiatrist at a n y ti me t o assess y o ur m o o d a n d well-
bei n g. Ge ner all y, a n M D f oll o w- u p will be  sc he d ule d o ne wee k after treat me nt a n d 
after t he st u d y c o n cl usi o n, b ut a d diti o nal M D f oll o w-u ps ca n b e sc he d ul e d  if 
nee de d .   
   
   
H o w m uc h ti me will e ac h st u dy pr oce d ure t a ke ?    
If y o u a gr ee t o be i n t his st u d y, t he f oll o wi n g will ha p pe n:     
• 
O nce y o u ha v e c o nse nte d, we will c o n d uct t he s cree ni n g visit , as ki n g q uesti o ns a b o ut 
y o ur me ntal  h ealt h hist or y a n d fa mil y bac k gr o u n d. We will  als o as k q uesti o ns t o  
deter mi ne y o ur eli gi bilit y  f or st u d y pr oce d ures. T h ese q uesti o ns will last a p pr o xi matel y 
1 h o ur, wit h t he e ntire visit lasti n g 3- 4 h o urs.    
• 
T he M RI sca n is a n i nte gral part of t his trial. We will sc he d ule y o u f or a o ne- h o ur 
f u ncti o nal M RI s ca n at t h e U C S D Ce nter bef ore y o ur a T B S treat me nt.    
• 
O n a se parate pr e -tr eat m e nt da y, we will c o n d uct a 2 t o 3-h o ur electr oe nce p hal o gra p h y 
( E E G) m eas ur e me nt si m ulta ne o us wit h T M S t o assess t he brai n’s res p o ns e e v o k e d b y 
T M S. F or t he E E G meas ure me nt, y o u will sit o n a c hair a n d w ear a ca p t o c oll ect 
i nf or mati o n a b o ut electri cal si g nals pr o d uce d b y differe nt parts of y o ur brai n. T his is 
t he  pre-tr eat me nt  T M S-E E G  visit.  T here  will  als o  be  a  si milar  T M S -E E G  visit  
c o n d ucte d p ost-treat me nt, i.e., at 1 t o 2 wee ks after t he treat me nt w as i nitiate d.   
• 
Tre at me nt C o urse -T h e treat me nt will c o nsist of 5 c o nsec uti ve da ys, a p pr o xi matel y 1 0 
h o urs eac h da y, wit h 1 0 sessi o ns per da y. Eac h treat me nt sessi o n will ta ke 1 0 mi n utes , 
f oll o we d b y a p pr o xi mat el y 5 0-mi n ute i nter vals. A d diti o nal ti me will be c ollecte d t o 
c o m plete t he s y m pt o m scree ni n g scales bef ore ha n d .   
   
   
W h at ris ks are ass oci ate d wit h t his st u dy ?    
Partici pati o n i n t his st u d y ma y i n v ol ve s o me a d de d ris ks or disc o mf orts. I n a d diti o n t o t he 
ris ks descri be d at t he be gi n ni n g of t his f or m,   
T he mai n ris ks ass ociate d wit h t his st u d y are relat e d t o t he r T M S treat me nt pr ot oc ol 
itself. r T M S has a str o n g, well- d oc u me nte d s afet y rec or d a n d has bee n use d t o treat ma n y 
t h o usa n ds of patie nts wit h de pressi o n. Please s ee bel o w f or m ore details. T here is als o a 
p ote ntial ris k of w orse ni n g m o o d a n d s uici dalit y, as wit h all a nti de pressa nt treat me nts, 
w hic h c o ul d tri g ger a n i n patie nt a d missi o n. Y o ur healt h will be f oll o we d cl osel y b y o ur 
st u d y tea m. If it is deter mi ne d t hat y o ur s y m pt o ms are w ors e ni n g, i ncl u di n g t he 
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
9  
i m me diate t hreat of self- har m, y o u will be ta ke n t o t he nearest e mer g e nc y r o o m. If at a n y 
p oi nt y o u feel u nsafe, pl ease g o t o y o ur nearest e m er ge nc y r o o m or c o ntact t he nati o nal 
s uici de h otli ne at ( 8 0 0)- 2 7 3- 8 2 5 5. T he ris k f or w orse ni n g m o o d or s uici dalit y is n ot 
necessaril y great er t ha n if y o u wer e t o deci de n ot t o partici pate i n t he st u d y.    
   
   
S pecific ris ks a n d si de effects ma y i ncl u de:      
   
E E G de vice:  p ossi ble ris k of disc o mf ort or s ki n irritati o n/ reacti o ns d ue t o scal p c o ntact 
wit h de vices.   
   
Ne ur o n a vi g ati o n he a d str a p : disc o mf ort ca use d b y press ure a p plie d t o t he stra p o n t he 
hea d.   
   
r T M S De vice:  r T M S is ge nerall y safe a n d well-t olerate d wit h little differe nce i n si de  
effects a n d ris ks bet w ee n act u al sti m ulati o n vers us s ha m ( place b o) r T M S. T he m ost 
seri o us a d vers e effect d uri n g r T M S is a ge neralize d seiz ure. T h e ris k of sei z ure is 
c o m para ble t o t hat of a nti de pressa nt treat me nt  a n d occ urs  i n less t ha n 0. 1 t o 0. 5 perce nt 
of patie nts w he n safet y g ui deli nes are f oll o w e d. Seiz ures t hat d o o cc ur are d oc u me nte d as 
bei n g self-li mite d a n d n ot lea di n g t o c hr o nic ill ness.   
T here is n o e vi de n ce of r T M S i ncreasi n g t he c h a n ces of se v ere ps y c h ol o gical dis or ders, 
b ut t here is a t he or etical ris k of t his ha p pe ni n g.   
Ot her a d verse effects:     
- 
Heari n g l oss: Pre ve nta bl e wit h t he use of f o a m ear pl u gs   
- 
Fai nti n g   
- 
Hea dac hes or n ec k stiff n ess  
-    U n pleasa nt clic ki n g n oise   
If y o u e x perie nce a n y of t he a b o ve or ot her s y m pt o ms, tell t he researc h staff. 
   
• 
M RI a n d T M S s h o ul d n ot be a d mi nistere d t o a n y o ne w h o has ma g n etic- se nsiti ve 
metal i n t heir hea d or ma g netic -se nsiti ve metal wit hi n 1 2 i nc hes of t he T M S c oil 
t hat ca n n ot be r e m o ve d. Fail ure t o f oll o w t his restricti o n c o ul d res ult i n seri o us 
i nj ur y or deat h.  O bjects t hat ma y ha ve t his ki n d of metal i ncl u de:    
 
o  A ne ur ys m cli ps or c oils    
o  Car oti d or cer e bral ste nts    
o  I m pla nte d sti m ulat ors    
o  Electr o des t o m o nit or y o ur brai n acti vit y    
o  Ferr o m a g netic i m pla nts i n y o ur ears or e yes    
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
1 0  
o  B ullet or s hra p nel fra g me nts    
Ot her metal de vices or o bjects i m pla nte d i n t he  hea d    
o  Pellets, b ullets, or metallic fra g me nts    
Y o u s h o ul d be a ware t hat t he ma g netic fiel ds ge n erate d i n a n M RI a n d b y t he T M S ma y 
da ma ge ma g n etic car ds, watc hes , a n d electrical d e vices.  Please re m o ve a n y s uc h ite ms 
bef ore t esti n g. If y o u ha v e a n y of t he a b o ve metals i n y o ur b o d y, y o u s h o ul d n ot 
partici pate i n t his st u d y.   
   
Ot her ris ks i n t his st u d y i ncl u de t he f oll o wi n g:   
• 
Y o u ma y e x perie nce w orse ni n g me ntal healt h s y m pt o ms d uri n g or after t his 
st u d y. T he researc h staff will peri o dicall y as k y o u q uesti o ns t o assess y o ur c urre nt 
m o o d. Y o u ca n al w a ys d eci de t o wit h dra w fr o m t he st u d y.    
   
Pers o nal i de ntifiers will be re m o ve d  fr o m t he i nf or mati o n c ollecte d as p art of t he 
researc h. After s uc h re m o val, t he data c o ul d b e use d f or f ut ure res earc h st u dies or 
distri b ute d t o a n ot her i n vesti gat or f or f ut ure res earc h st u dies a n d res earc h s p o ns ors 
wit h o ut y o ur a d diti o nal i nf or me d c o ns e n t. Beca us e t his is a researc h st u d y, t here ma y 
als o be s o me u n k n o w n ris ks t hat are c urre ntl y u nf oreseea ble.   
   
T his cli nical trial will be descri be d  at htt p:// w w w. Cli nical Trials. g o v , as re q uire d b y U. S. 
La w. T his We b site will n ot i ncl u de i nf or mati o n t hat ca n i de ntif y y o u. At m ost, t he We b 
site will i ncl u de a s u m mar y of t he res ults. Y o u ca n searc h t his We b site at a n y ti me.   
   
Y o u wi ll n ot recei ve a n y res ults of t his st u d y; h o we ver, if n e w i nf or mati o n rele va nt t o 
y o ur healt h or safet y bec o mes a vaila ble, y o u will be i nf or me d pr o m ptl y.    
   
   
W h at are t he alter n atives t o p artici p ati n g i n t his st u dy ?   
I n a d diti o n t o t he alter nati ves t o partici pati o n liste d at t he be gi n ni n g of t his for m , ot her 
alter nati ves are n ot t o partici pate. Y o ur decisi o n t o partici pate i n t his st u d y will n ot affect 
y o ur eli gi bilit y t o recei ve sta n dar d- of-care t hr o u g h t he I nt er ve nti o nal Ps yc hiatr y cli nic, 
w hic h ma y i ncl u de el ectr oc o n v ulsi ve t hera p y, k eta mi ne, or ot her f or ms of treat me nt.   
   
W h at be nefits c a n be re as o n a bly e x pecte d ?   
I n a d diti o n t o t he be nefits liste d at t he be gi n ni n g of t his f or m, t he i n vesti gat ors ma y als o 
lear n m ore a b o ut M D D a n d s uici dalit y. T hese pr o ce d ures m a y or ma y n ot directl y be nefit 
y o u. H o we ver, re p eat sessi o ns ma y all o w y o u t o e x perie nce a p ositi ve c h a n ge i n me ntal 
healt h .    
   
W h at h a p pe ns if y o u c h a n ge y o ur mi n d a b o ut p artici p ati n g ?   
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
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Y o u ma y ref us e t o partici pate or st o p y o ur partici pati o n at a n y ti me wit h o ut pe nalt y a n d 
wit h o ut je o par dizi n g y o ur c o nti n ui n g me dical care at t his i nstit uti o n. If y o u deci de t hat 
y o u n o l o n ger wis h t o c o nti n ue i n t his st u d y, y o u will be re q ueste d t o:    
• Le t t he resear c hers k n o w i m me diatel y t hat y o u wis h t o wit h dra w fr o m t he researc h.   
• Ret ur n t o t he researc h ce nter f or tests t hat ma y be nee de d f or y o ur safet y.   
• Disc uss y o ur f ut ure me di cal care, if a n y, wit h t he researc hers a n d/ or y o ur D oct or.    
   
If y o u c h o ose t o wit h dr a w fr o m t he treat me nt p orti o n of t he st u d y or ca n n ot fi nis h all of 
t he sc he d ule d tr eat me nt a p p oi nt me nts d ue t o u nf oresee n circ u msta nces, y o u ma y still 
a gree t o p artici pate i n t he re mai ni n g cli nical assess me nts as sc he d ule d.     
   
T hr o u g h o ut y o ur partici p ati o n i n t his st u d y, y o u ma y c o nti n ue y o ur re g ular a p p oi nt me nts 
wit h y o ur ori gi nal treati n g p h ysicia n.   
   
Y o u will be i nf or me d if a n y i m p orta nt ne w i nf or m ati o n is f o u n d d uri n g t his st u d y t hat 
ma y aff ect y o ur decisi o n t o c o nti n ue.   
   
C a n y o u be wit h dr a w n fr o m t he st u dy wit h o ut y o ur c o nse nt ?    
Y o u ma y be wit h dra w n fr o m t he st u d y f or t he f oll o wi n g reas o ns:    
- 
A st u d y p h ysicia n belie v es t hat it is i n y o ur best i nterest n ot t o c o nti n ue wit h t he 
st u d y.    
- 
Y o u be gi n t o p ose a seri o us t hreat t o y o ur o w n life or t o a n ot her pers o n’s life -  
Y o u feel u n ma n a gea bl e pai n/ disc o mf ort at a n y p oi nt t hr o u g h o ut t he st u d y.   
- 
Y o u n o l o n ger wis h t o partici pate i n t he re mai n d er of t he st u d y.   
- 
Y o u ma y als o be wit h dra w n fr o m t he st u d y if y o u d o n ot f oll o w t he i nstr ucti o ns 
gi ve n t o y o u b y t he st u d y pers o n nel.   
- 
It is deter mi ne d t hat y o ur treat me nt sti m ulati o n i nte nsit y is a b o ve a pre -
esta blis he d li mit f or i ncl usi o n ( 6 5 % Mac hi ne Sti m ulat or O ut p ut (M S O)).   
- 
Y o u ma y als o be wit h dra w n fr o m t he st u d y if y o u d o n ot f oll o w t he i nstr ucti o ns 
gi ve n t o y o u b y t he st u d y pers o n nel.   
   
 
Will y o u be c o m pe ns ate d f or p artici p ati n g i n t his st u dy ?    
I n c o m pe nsati o n f or y o ur ti me a n d tra vel, y o u ma y recei v e a ma xi m u m of $ 6 0, de pe n di n g 
o n y o ur le vel of partici pati o n: y o u will recei ve $ 2 0 f or eac h M RI sessi o n a n d $ 2 0 f or 
eac h ti me y o u partici pate i n t he T M S - E E G sessi o n. All c o m pe nsati o n will be pr o vi de d at 
t he e n d of t he st u d y i n t he f or m of e-gift car ds t o retailers ( e. g., A maz o n).    
   
Are t here a ny c osts ass oci ate d wit h p artici p ati n g i n t his st u dy ?    
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
1 2  
T he T M S treat me nts w ill be su p plie d a t n o c os t w hil e y o u ta ke pa rt in t hi s st u d y. It is 
p ossi bl e tha t the T M S treat me nts m a y n ot co nti n ue to be pr o vi de d w hil e y o u ar e in t he  
st u d y. Alt h o u g h n ot li kel y, if thi s oc c urs, y o ur st u d y d octor w ill tal k t o y o u ab o ut y o ur 
o pti o ns. 
W h at  if yo u  ar e i nj ure d as a  direct res ult of be i n g i n t his st u dy ?   
If y o u ar e inj ure d directl y d ue to pa rtici pati o n i n t his researc h, t he U ni versit y of  
Calif or ni a w ill pr o vi de an y me dica l care y o u nee d t o t reat th os e inj uries. T he U ni versit y 
will n ot pr o vi de y o u wit h a n y ot her f or m of c o m pe nsati o n if y o u are i nj ure d. Y o u ma y 
call the  U C S D Office of I R B A d mi nistrati o n ( OI A) at 8 5 8- 2 4 6- 4 7 7 7  f or m ore 
i nf or mati o n a b o ut t his, t o i n q uire a b o ut y o ur ri g hts as a researc h s u bject, or t o re p ort 
researc h-relate d  pr o ble ms.   
W h at  a b o ut y o ur co nfi de nti ality ?     
Researc h rec or ds will be ke pt c o nfi de ntial t o t he e xte nt all o we d b y la w.     
U n der Calif or nia la w, t he o nl y e xce pti o ns t o t his pri vac y r ule are: 1) if y o u e x press 
s uici dal t h o u g hts or pla ns, t he c o nfi de ntialit y ma y nee d t o be br o ke n t o hel p y o u; 2) We 
ma y nee d t o re p ort i nf or mati o n a b o ut k n o w n or reas o na bl y s us pecte d i nci de nts of a b use 
or ne glect of a c hil d, de pe n de nt a d ult or el der i ncl u di n g p h ysical, se x ual, e m oti o nal, a n d 
fi na ncial a b use or ne glect. If a n y i n vesti gat or has or is gi ve n s uc h i nf or mati o n, he or s he 
ma y re p ort s uc h i nf or mati o n t o t he a p pr o priate a ut h orities.    
De-i de ntif yi n g all 
meas ure me nts a n d i n di vi d ual test res ults a n d treati n g t he m 
c o nfi de ntiall y will 
mi ni mize 
pri vac y ris ks. Writte n i nf or me d c o nse nt/asse nt a n d 
mi ni m u m i de ntif yi n g i nf or mati o n  c ollecte d  fr o m  partici pa nts  will  be  st ore d  i n  
sec ure,  HI P A A-co m plia nt electr o nic l ocati o ns fr o m t he sec urel y st ore d de-i de ntifie d 
st u d y data s o t hat i n di vi d uals ca n n ot be easil y c o n necte d t o t he st u d y res ults. T he U C S D 
I nstit uti o nal Re vie w B oar d ma y re vie w researc h rec or ds.    
W h o c a n y o u c all if y o u h ave q uesti o ns ?    
T his st u d y has bee n e x plai ne d t o y o u, a n d y o ur q uesti o ns ha ve bee n a ns were d. Y o u ma y 
reac h Dr.  Cor y R. Weiss ma n at ( 8 5 8) 2 0 7- 0 9 3 8 if y o u ha ve ot her q uesti o ns or researc h-
relate d pr o ble ms.   
Y o u ma y  call the U C S D  Office  of I R B Ad mi nistrati o n  ( OI A)at 8 5 8- 2 4 6- 4 7 7 7  t o i n q uire 
a b o ut y o ur ri g hts as a researc h s u bject or t o re p ort researc h-relate d pr o ble ms.   
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6

U C S D I R B # 8 0 1 5 6 6 
4 N o ve m ber 2 0 2 4  
1 3  
 
 
 
 
 
 
 
Y o ur Si g n at ure a n d C o nse nt    
 I h ave receive d a c o p y of t his c o nse nt d oc u me nt a n d a c o py of t he “ Ex peri me nt al 
P artici p a nt's Bill of Ri g hts ” t o kee p.  I a gree t o p artici p ate i n t he rese arc h descri be d i n 
t his f or m.  
  
 
 
Pri nte d Na me of Partici p a nt  
  
 
 
Si g nat ure of Partici pa nt   
   
                                                                   Date  
  
  
 
Pri nte d Na me of Pers o n O btai ni n g C o nse nt  
  
 
 
Si g nat ure of Pers o n                                                                                               Date  
O btai ni n g C o nse nt           
 
   
* *If oral c o ns e nt or w ai ver of d oc u m e nte d c o nse nt is re q ueste d, n o si g nat ure li ne is 
nee de d   
   
   
   
 
Pr ot o c ol # 8 0 1 5 6 6 | v 8 6 | E x pir e s: M ar 2 9, 2 0 2 6