The Effects of Vibrotactile Stimulation (Not Impossible Vibrohealth) on Motor Control and Symptoms in Patients With Movement Disorders
Phase: NA
Conditions: Parkinson Disease, Essential Tremor, Dystonia
Sponsor: University of Florida

Protocol  
1.   Project  Title:  
A  pilot  study  investigating  the  effects  of  vibrotactile  stimulation  (Not  Impossible  
Vibrohealth)  on  motor  control  and  symptoms  in  patients  with  movement  disorders  
  
2.   Investigators:  
Christopher  W.  Hess,  MD  (PI)  
Wei  Hu,  MD  (Co-­I)  
Michael  S.  Okun,  MD  (Co-­I)  
  
3.   Abstract:  
Non-­invasive  vibrotactile  stimulation  (VTS)  of  the  skin  has  long  been  reported  anecdotally  
to  potentially  improve  motor  control  and  reduce  the  motor  symptoms  of  patients  with  
movement  disorders  including  Parkinson’s  disease.  Though  few  rigorously  controlled  
clinical  trials  have  been  performed  on  the  effects  of  VTS,  devices  that  provide  VTS  have  
received  significant  media  attention  as  potential  non-­medical  interventions  for  movement  
disorders.  In  this  study,  we  will  test  the  effect  of  VTS  applied  non-­invasively  to  patients  
with  movement  disorders  to  determine  if  there  are  any  beneficial  effects  of  VTS  on  
common  tasks  of  motor  control  and/or  abnormal  motor  symptoms  in  patients  with  PD,  
essential  tremor  (ET),  and  dystonia.    
  
4.    Background:  
Movement  disorders  can  be  defined  as  neurologic  syndromes  in  which  there  is  either  an  
excess  or  paucity  of  voluntary  and/or  automatic  movements  that  is  not  due  to  weakness  
or  spasticity.  A  prototypical  example  is  Parkinson’s  disease  (PD),  a  chronic  progressive  
neurodegenerative  disorder  characterized  by  rigidity,  bradykinesia,  gait  and/or  postural  
instability,  and  resting  tremor.  1  The  classical  PD  tremor  has  a  dominant  frequency  of  3–
6Hz  and  is  most  often  present  at  rest  in  the  upper  extremities  of  the  affected  subjects.  
Other  movement  disorders  include  essential  tremor  (ET,  in  which  tremor  is  

predominantly  present  with  action)  and  dystonia  (in  which  tremor  is  associated  with  a  
syndrome  of  abnormal  muscle  contractions  resulting  in  involuntary  movements  and  
postures).  Although  medical  and  surgical  therapies  are  available  for  the  symptomatic  
treatment  of  these  movement  disorders,  current  treatment  options  can  produce  
significant  side  effects  and  often  provide  incomplete  benefit  for  the  motor  symptoms  of  
these  diseases.  Therefore,  continued  investigation  of  new  potential  treatment  options  is  
an  important  priority.    
The  application  of  external  non-­invasive  vibrotactile  stimulation  (VTS)  of  the  skin  as  a  
therapeutic  intervention  for  movement  disorders  has  been  of  interest  since  the  19th  
century,  when  Jean-­Martin  Charcot  anecdotally  observed  a  relief  of  symptoms  following  
the  use  of  a  vibrating  chair  in  patients  with  PD.  2  Since  then,  whole  body  vibrating  
massage  has  been  investigated  as  a  potential  means  to  reduce  the  symptoms  of  PD,  
however  results  have  been  inconsistent.  3-­7  Similarly,  devices  that  provide  VTS  have  
been  investigated  in  small  studies  for  the  amelioration  of  symptoms  of  essential  tremor  
and  dystonia,  with  only  limited  conclusions  possible  to  date  due  to  sample  size  and  
study  design  limitations.  8,9  
At  the  current  time,  it  is  estimated  that  at  least  1  in  5  adults  use  at  least  one  wearable  
health-­related  technology,  and  wearable  devices  intended  to  track  the  symptoms  of  PD  
10  are  already  in  clinical  use.  Wearable  devices  that  provide  VTS  (such  as  the  as  the  
Vibrohealth  system  recently  developed  by  Not  Impossible  Labs,  
https://www.youtube.com/watch?v=G7T53xN1IqI)  have  received  significant  attention  in  
the  lay  press  and  within  patient  support  groups.  As  more  and  more  wearable  devices  
(which  may  be  marketed  directly  to  patients)  are  developed,  it  will  be  critically  important  
for  academic  clinical  researchers  to  participate  in  testing  the  efficacy  of  these  devices  in  
rigorous  clinical  trials.  This  need  for  independent  study  has  been  recognized  by  the  
Parkinson’s  Foundation  (PF),  which  has  selected  the  University  of  Florida  as  a  research  
site  tasked  with  determining  the  optimal  device  settings  and  testing  the  Not  Impossible  
Vibrohealth  system  as  an  adjunctive  therapy  for  movement  disorders.  We  will  
accomplish  this  through  the  following  specific  aims.    
5.    Specific  Aims:  

Specific  Aim.  Evaluate  the  feasibility,  reliability,  and  clinical  effects  of  VTS  on  
basic  tasks  of  motor  control  and  on  the  motor  symptoms  of  patients  with  
movement  disorders.    
Hypothesis:  VTS  will  produce  beneficial  effects  on  basic  tasks  of  motor  control  and  
abnormal  motor  symptoms  in  patients  with  movement  disorders.  VTS  Settings  will  
include  continuous  stimulation  between  60-­120  Hz,  intermittent  stimulation  at  ½  
baseline  step  frequency  during  walking,  and  sham  stimulation  (2  seconds  of  30  Hz  
stimulation  only  at  stimulation  onset).  
  
6.   Research  Plan:  
6.1    Design  Overview:  
This  cross-­sectional  pilot  study  aims  to  identify  the  optimal  device  settings  and  
preliminarily  test  the  efficacy  of  the  Not  Impossible  VibroHealth  device  in  improving  
basic  measure  of  motor  control  and  symptoms  in  patients  with  PD  and  other  movement  
disorders  in  the  off-­medication  state.  After  informed  consent,  screening,  and  
recruitment,  the  effects  of  VTS  will  be  evaluated  on  basic  tests  of  motor  control  and  
common  movement  disorders  symptoms.    
  
6.2    Participants:  
We  will  recruit  30  patients  with  PD  who  are  between  the  ages  of  18-­80  years  old  and  
independently  living  in  the  community.  Will  additionally  recruit  up  to  5  patients  with  ET  
and  up  to  5  patients  with  dystonia.  To  account  for  screening  failures  or  patients  who  
cannot  tolerate  the  sensory  stimulation,  we  anticipate  screening  and  consenting  ~50  
individuals.  
  
6.3    Recruitment:  
Recruitment  will  occur  exclusively  through  the  UF  movement  disorders  program  at  the  
Fixel  Institute  for  Neurological  Diseases  at  UF  Health.  We  expect  to  recruit  patients  prior  
to  and  during  routine  scheduled  clinic  visits  with  e-­consenting  (electronic  informed  
consent).  

  
6.4    Inclusion/Exclusion  Criteria:  
6.4a.  Inclusion  criteria:  
•  
Age  18-­80  and  able  to  provide  informed  consent.  
•  
Have  a  diagnosis  of  Parkinson’s  disease,  essential  tremor,  or  cervical  dystonia  
made  by  a  movement  disorders  specialist.  
•  
Medically  optimized  without  planned  medication  changes  for  the  duration  of  the  
study.    
•  
For  patients  with  ET,  they  will  have  a  score  of  at  least  2  on  items  5  and  6  of  the  
Fahn-­‐‑Tolosa-­‐‑Marin  (FTM)  Tremor  Rating  Scale.    
•  
For  patients  with  dystonia,  they  will  have  abnormal  dystonic  postures  of  the  head  
and  not  isolated  head  tremor  
6.4b.  Exclusion  criteria:      
•  
The  presence  of  additional  neurologic  diseases,  that  might  confound  testing  or  the  
coexistence  of  PD  and  ET  together  (action  tremor  that  was  present  prior  to  the  
development  of  parkinsonism).  
•  
Symptoms  of  peripheral  neuropathy  at  the  wrist  (reduced  vibratory,  pinprick,  or  
temperature  sensation)    
•  
Montreal  cognitive  assessment  (MoCA)  score  <  20  or  previously  documented  
dementia  
•  
Unable  to  walk  without  a  walking  aid  (e.g.  cane,  stick,  walker)  

6.5  Device  Description  and  Previous  Studies  
The  Vibrohealth  system  consists  of  4  vibrating  
devices  on  bands  and  a  magnetic  contact  charger  
(Figure  1).  The  devices  are  paired  with  a  cell  phone  
application  (to  be  used  solely  by  research  
investigators)  that  adjusts  the  parameters  of  vibratory  
stimulation  during  research  visits  (Figure  2).    
  
The  device  consists  of  an  actuator/sensor  that,  when  
placed  against  the  surface  of  the  skin,  produces  a  
vibrotactile  sensation  (vibration)  through  rapid  lateral  
(side  to  side)  motion.  The  intensity  of  the  vibration  
produced  by  the  Vibrohealth  device  is  far  less  than  
that  produced  by  commercially  available  massagers  
that  provide  vibratory  stimulation  for  relaxation  using  
similar  technology.  The  sensor  in  the  device  is  a  tri-­
axial  accelerometer  and  gyroscope  that  measures  
position  using  the  same  technology  as  smartphones.  
  
A  previous  version  of  the  Vibrohealth  device  was  
evaluated  in  2017-­2018  on  52  patients  with  PD  and  
resting  tremor  at  the  Mount  Sinai  Hospital  in  New  
York  City  in  a  study  funded  by  the  device  developer  
(Not  Impossible).  The  Vibrohealth  device  was  deemed  
a  nonsignificant  risk  device  and  was  approved  by  full  board  IRB  review  (IRB  #17-­
00555).  There  were  no  adverse  events  in  any  subjects  receiving  VTS.  However,  the  
stimulation  setting  intended  to  serve  as  a  sham  control  setting  (low  amplitude  
continuous  vibration)  appeared  to  reduce  resting  tremor  in  approximately  60%  of  
patients,  suggesting  that  the  vibration  settings  used  in  the  protocol  were  inadequately  
investigated  prior  to  study  design.  Though  this  study  is  being  prepared  for  publication  by  
the  authors  at  Mount  Sinai  Hospital  as  a  safety  and  feasibility  study,  the  Parkinson  

Foundation  has  decided  to  fund  further  pilot  testing  to  ensure  that  any  future  clinical  
trials  aimed  at  testing  the  efficacy  of  VTS  are  planned  appropriately.    We  have  tested  
the  Vibrohealth  device  on  7  patients  during  our  initial  pilot  testing  since  IRB  approval  
without  any  adverse  events.    
  
6.6    Screening/Baseline  Interview  and  Measures:  
Recruitment  will  be  conducted  at  the  UF  Health  Fixel  Institute  for  Neurological  Diseases  
via  pre-­review  of  outpatient  appointments,  review  of  the  IRB  approved  movement  
disorders  database,  and  during  standard  of  care  (SOC)  visits.  Clinic  providers  involved  
with  the  research  study  who  provide  clinical  care/intervention  for  treatment  may  also  
discuss  the  protocol/research  with  their  patient.  If  participants  are  identified  through  pre-­
review  of  outpatient  records/lists/appointments,  providers  associated  with  clinical  care  for  
the  subject  will  be  notified  of  the  subject’s  potential  availability.  No  other  information  will  
be  collected  during  the  pre-­screening  process.  The  provider  will  then  mention  the  study  to  
the  patient,  if  appropriate.  When  interested,  subjects  will  either  contact  us  about  the  study  
or  the  clinic  providers  will  notify  study  coordinators  of  participant  interest.  
  
Study  personnel  will  tell  the  potential  participants  about  the  study.  The  study  personnel  
will  consist  of  the  investigators  (UF  faculty),  staff  study  coordinators,  and  clinical  
movement  disorders  fellows.  All  study  coordinators  will  be  appropriately  trained  to  meet  
HIPPA  and  IRB  requirements.  The  pre-­screening  of  records  will  only  be  carried  out  by  
study  coordinators  who  already  have  approved  EPIC  medical  record  access.    
Patients  will  also  be  identified  using  the  Fixel  Institute  for  Neurological  Diseases  patient  
database  (Quantifying  Deficits  in  Patients  with  Movement  Disorders).  Patients  who  have  
provided  informed  consent  to  have  their  medical  information  stored  in  the  database  and  
have  indicated  that  they  would  like  to  be  contacted  about  future  research  studies  may  be  
contacted  (IRB201501166).  Potential  participants  will  be  identified  using  database  queries  
including  diagnosis,  age,  location,  most  recent  UPDRS,  and  most  recent  clinical  visit.  
These  identified  potential  participants  will  then  be  contacted  by  study  coordinators  to  
inform  and  invite  them  to  participate  in  this  research  study.  
  

Once  a  potential  participant’s  interest  in  participating  in  the  study  is  established,  the  study  
personnel  will  read  from  an  approved  telephone  script  to  provide  details  about  the  study  
and  the  inclusion  and  exclusion  criteria.  If  potential  participants  are  still  interested  and  are  
eligible  to  participate  in  the  study,  they  will  then  be  scheduled  for  an  e-­consenting  
appointment.    
  
6.7    Duration  of  Study  and  Overview  of  Procedures  and  Protocol:  
Testing  will  occur  over  the  course  of  a  single  day  at  the  Fixel  Institute  for  Neurological  
Diseases.  Similar  to  new  patient  clinical  evaluations,  subjects  will  be  instructed  to  
withhold  any  PD,  ET,  or  dystonia  medications  for  12  hours  prior  to  testing.  The  study  
visit  will  last  up  to  4  hours  and  will  include  a  variety  of  motor  tasks  and  clinical  tests  
(described  in  detail  below)  both  on  and  off  VTS.  For  Parkinson’s  disease  and  essential  
tremor  patients,  the  devices  will  be  worn  on  the  wrist  and/or  ankles.  For  patients  with  
dystonia,  the  devices  will  be  adhered  to  the  skin  of  the  neck  using  medical  grade  double  
sided  tape  and  a  latex  medical  wrap.  Patients  with  PD  will  undergo  a  more  
comprehensive  testing  evaluation,  while  patients  with  ET  or  dystonia  will  undergo  a  
brief,  more  focused  evaluation.  Subject  responses  will  not  be  compared  across  
diseases  given  the  preliminary  nature  of  the  research  and  analysis.    Outcomes  to  be  
measures  are  described  below  in  the  order  that  they  will  be  tested  for  each  individual  
subject  group  (PD,  ET,  dystonia).    
  
Baseline  testing:  
MDS-­UPDRS:  Select  measures  from  the  motor  section  of  the  Movement  Disorders  
Society  Unified  Parkinson’s  Disease  Rating  Scale  (MDS-­UPDRs).  11  The  MDS-­UPDRS  
is  a  revision  of  the  Unified  Parkinson’s  Disease  Rating  Scale  (UPDRS)  originally  
developed  in  the  1980s.  The  scale  is  used  in  the  clinic  as  well  as  in  research  to  
measure  PD  symptom  severity.  Individual  measures  are  rated  as  0  (normal)  to  4  
(severe).  
  

Montreal  Cognitive  Assessment  (MoCA):  The  MoCA  is  a  cognitive  screening  test  
designed  to  assist  Health  Professionals  in  the  detection  of  mild  cognitive  impairment  
and  dementia.  It  will  be  used  to  exclude  patients  with  cognitive  impairment  significant  
enough  to  confound  the  research  variables  of  interest.  
  
6.7a:  Outcomes  to  be  measured  in  subjects  with  PD:  
  
Quantitative  Tremor  Assessment:  An  external  accelerometer  (Delsys  Trigno;;  
https://delsys.com/trigno/)  will  be  adhered  to  the  skin  of  the  dorsum  of  the  hand  and  will  
be  used  to  quantify  displacement  of  the  hand  due  to  tremor  in  the  settings  listed  below.  
Delsys  Trigno  sensors  have  been  used  in  multiple  prior  UF  IRB  approved  studies  and  is  
FDA  and  CE  registered  with  FCC  ID,  and  is  certified  IEC601-­1  (General  Requirements  
for  Medical  Devices)  and  IEC601-­1-­2  (electromagnetic  compatibility  requirements  for  
Medical  Devices)  with  a  UL  recognized  Internal  Battery.  
  
-­  1.  Sitting  at  rest  
-­  2.  Sitting  with  both  arms  outstretched  
-­  3.  Sitting  at  rest  while  performing  a  distracting  cognitive  task  (reciting  the  months  of  
the  year  backwards)  
-­  4.  Transition  from  rest  to  posture  (arms  held  directly  in  front  of  patient)  for  10  seconds  
  
Kinesia  One  accelerometer:  The  following  select  measures  of  MDS-­UPDRS  Part  III:  
Motor  Examination  will  be  repeated  before  and  during  VTS:  
  
3.4  Finger  tapping  
3.5  Hand  movements  
3.6  Rapid  alternating  movements  (pronation-­supination  of  the  hands)  
  
These  measures  will  be  quantified  using  the  Kinesia  one  accelerometer  system  
(http://glneurotech.com/kinesia/products/kinesia-­one/),  which  uses  a  propriety  algorithm  

to  calculate  a  severity  score  on  a  0-­4  scale  that  has  been  shown  to  highly  correlate  with  
clinician  ratings.  The  Kinesia  one  system  has  been  used  in  multiple  prior  UF  IRB  
approved  studies  and  is  FDA  cleared  to  market  and  CE  marked.  The  device  is  placed  
on  the  index  finger  during  testing  and  senses  movement.    
  
Reaction  time  task:  Subjects  will  look  at  a  central  fixation  symbol  on  computer  screen  
and  press  a  computer  keyboard/mouse  button  when  the  GO  signal  appears.  The  time  
between  the  onset  of  the  fixation  cross  and  the  green  GO  signal  will  vary  so  that  the  
onset  of  the  GO  signal  will  not  be  predictable.  The  time  between  appearance  of  the  GO  
signal  and  recorded  keyboard  response  will  be  recorded  as  reaction  time.  13  
  
Functional  Dexterity  Task  (FDT):  The  FDT  is  a  pegboard  assessment  of  manual  
dexterity.  It  is  a  square  pegboard  with  16  holes  and  16  pegs.  Using  a  stopwatch,  the  
examiner  measures  the  time  that  it  takes  for  the  subject  to  turn  over  all  the  pegs  on  the  
board,  as  quickly  as  possible,  using  one  hand  at  a  time.  A  5-­s  penalty  is  added  every  
time  the  subject  supinates  or  touches  the  board  for  assistance,  while  a  10-­s  penalty  is  
added  if  the  subject  drops  a  peg.  Two  scores  are  obtained:  the  net  time  (in  seconds)  
quantifies  the  speed  of  the  hand  dexterity;;  the  total  score  (time  plus  penalties)  quantifies  
the  quality  of  the  performance.  The  test  ends  when  both  hands  have  completed  the  task  
and  the  total  score  for  each  hand  determines  the  functional  level.  
  
Timed-­up-­and-­go  (TUG)  gait  task:  Subjects  are  asked  to  stand  up  from  a  chair,  walk  3  
meters  to  a  horizontal  line  marked  with  red  tape  on  the  floor,  turn  around,  walk  back  and  
sit  down,  at  a  comfortable  pace.  12  Two  outcome  assessments  will  be  used  during  the  
TUG  task.  After  obtaining  video  consent  during  the  informed  consent  process,  we  will  
videotape  the  TUG  test  which  will  be  scored  by  a  blinded  rater  for  number  of  freezing  
episodes  and  TUG  completion  time  in  seconds.  The  TUG  task  will  be  performed  on  the  
instrumented  GAITRite  mat  (https://www.gaitrite.com/)  which  is  located  in  the  clinic  and  is  
routinely  used  for  clinical  care.  The  GAITRite  mat  measures  and  records  spatiotemporal  
components  of  gait  including  stride  length,  regularity,  cadence,  left-­sided  step  length,  

right-­sided  step  length,  velocity,  and  an  overall  functional  ambulation  score.  The  
GAITRite  mat  is  FDA  registered,  CE  Certified  and  ISO  standard  compliant.  
Clinical  Global  Impression  (CGI-­I)  Scale:  The  Clinical  Global  Impression-­Improvement  
(CGI)  scale  was  developed  for  use  in  NIMH-­sponsored  clinical  trials.  14  It  is  a  7-­point  
scale  that  requires  the  clinician  to  assess  how  much  a  specific  symptom  has  improved  
or  worsened  relative  to  a  baseline  state  prior  to  an  intervention.  
  
6.7b:  Outcomes  to  be  measured  in  subjects  with  ET:  
FTM-­TRS:  Select  measures  from  the  Fahn-­Tolosa-­Marin  Tremor  Rating  Scale  (FTM-­
TRS).  15  The  FTM-­TRS  is  the  most  commonly  used  rating  scale  in  clinical  trials  of  
essential  tremor.  It  rates  tremor  on  a  scale  of  0  (no  tremor)  to  4  (severe).  Select  
measures  of  FTM-­TRS  to  be  tested  are  as  follows:  
  
5.  right  upper  extremity  tremor  (rest,  posture,  action):  
6.  left  upper  extremity  tremor  (rest,  posture,  action):  
10.  Handwriting  
22.  Spiral  drawing  
  
Clinical  Global  Impression  (CGI-­I)  Scale:  as  described  above  in  PD  section.  
  
6.7c:  Outcomes  to  be  measured  in  subjects  with  dystonia:  
TWSTRS:  Select  measures  from  the  motor  section  of  the  Toronto  Western  Spasmodic  
Torticollis  Rating  Scale  (TWSTRS).  16  The  TWSTRS  is  the  most  commonly  used  rating  
scale  to  rate  dystonia  severity  in  patients  with  cervical  dystonia.  Ratings  vary  depending  
on  the  individual  questions.  Select  measures  of  the  TWSTRS  section  A  to  be  tested  are  
as  follows:  
1.  Rotation  
2.  Laterocolis  

3.  Anterocollis/retrocollis  
4.  Lateral  shift  
5.  Sagittal  shift  
  
Clinical  Global  Impression  (CGI-­I)  Scale:  as  described  above  in  PD  section.  
  
7.    Outcome  and  Statistical  Approaches:  
For  essential  tremor  and  dystonia,  the  aims  of  this  unblinded  pilot  study  are  to  identify  the  
optimal  settings  of  VTS  that  are  most  promising  to  be  tested  in  future  clinical  trials,  
statistical  analysis  will  be  limited  to  basic  measures  of  central  tendency.  We  will  compare  
scores  and  values  on  the  individual  outcome  measures  listed  above  both  on  and  off  VTS,  
and  within  disease  group  means  for  each  measure  will  be  used  to  help  guide  the  choice  
of  settings  to  be  tested  in  future  studies.  This  pilot  study  will  not  be  powered  for  between  
disease  groups  analysis  or  to  test  the  efficacy  of  VTS  for  ET,  or  dystonia.    
For  Parkinson’s  disease,  we  expect  to  have  data  sufficient  to  justify  exploratory  statistical  
analysis.  We  have  estimated  that  the  number  of  patients  included  will  allow  for  statistical  
analysis  of  patient’s  task  performance  before  and  during  VTS.  This  was  based  on  a  
medium  effect  size  (cohen’s  d  =  0.50)  for  the  comparison  of  tremor  power  during  VTS  
versus  baseline.  With  an  alpha  of  0.05  and  power  of  0.80,  the  required  sample  size  is  27  
(based  on  a  one-­sided  paired  sample  t-­test).  Thus,  by  recruiting  30  participants  with  PD,  
our  sample  size  will  give  us  sufficient  statistical  power  to  detect  an  effect  with  medium  
effect  size.  Statistical  analysis  will  consist  of  a  repeated  measures  ANOVA  on  the  change  
in  tasks  performance  scores  relative  to  baseline.  All  post-­hoc  analyses  will  be  corrected  
for  multiple  comparisons  using  Bonferroni  correction.    
  
8.    Methodological  Limitations  and  Potential  Challenges:    
Potential  challenges  that  may  occur  during  the  study  include  subject  discontinuation  prior  
to  completion  of  data  collection  due  to  boredom  or  irritation  of  the  skin  from  vibration.  
Partial  collected  data  will  still  be  useful  in  helping  to  guide  the  choice  of  simulation  

parameters  in  future  clinical  trials  to  test  the  potential  of  VTS  as  an  adjunctive  therapy  to  
improve  motor  control  or  reduce  the  symptoms  of  PD,  ET,  or  dystonia.      
  
9.  Data  Management  Plan:  
All  data  (including  videos)  collected  from  subjects  will  be  stored  in  encrypted  computer  
files  with  secure  passwords.  All  data  entered  into  such  electronic  storage  files  will  be  
assigned  subject  ID  numbers  that  are  de-­identified  to  ensure  that  all  information  is  
protected.  Data  will  be  kept  in  a  password  protected  encrypted  database  which  can  only  
be  accessed  by  the  investigator  and  their  staff.    All  data  and  assessments  will  be  under  
the  direction  of  the  Co-­PI’s  who  will  supervise  research  coordinators  and  assistants.    
Subject  numbers  will  be  assigned  consecutively  as  follows:    
  
Subjects  with  PD:  PD1,  PD2,  etc.  to  PD30  
Subjects  with  ET:  ET1,  ET2,  etc.  to  ET5  
Subjects  with  dystonia:  DYT1,  DTY2,  DYT3,  etc.  to  DYT5  
  
De-­identified  data  may  be  compared  with  data  collected  by  other  testing  sites  funded  by  
the  Parkinson’s  Foundation.  No  data  that  includes  any  HIPAA  identifiers  will  be  available  
to  Not  Impossible  or  to  other  research  groups  or  anyone  outside  of  the  study  researchers  
and  coordinators  noted  in  this  protocol.    
  
10.    Possible  Discomforts  and  Risks:  
In  general,  the  risks  are  minimal  for  individuals  who  participate  in  this  study.  As  the  
intensity  of  the  vibration  produced  by  the  Vibrohealth  device  is  far  less  than  that  which  is  
produced  by  commercially  available  massagers  that  provide  vibratory  stimulation  to  the  
body,  the  incidence  and  severity  of  any  adverse  effects  is  expected  to  be  limited,  and  no  
adverse  events  occurred  in  a  previous  trial  using  the  Vibrohealth  device  in  over  50  
patients  with  PD  and  in  our  pilot  testing  at  UF  of  8  subjects.  With  regard  to  discomforts  
and  risks,  first  the  VTS  stimulation  could  be  annoying  or  unpleasant,  and  there  is  the  
possibility  of  minor  skin  irritation  at  the  site  where  the  wearable  devices  are  placed.  

Second,  subjects  will  be  asked  to  come  to  testing  sessions  OFF  medications  (as  is  done  
during  standard-­of-­care  initial  clinic  visits)  in  order  to  reduce  confounding  effects  of  
medications,  which  could  be  temporarily  uncomfortable.  Third,  patients  may  also  find  the  
tasks  and  scales  tedious  or  boring.  To  minimize  fatigue  associated  with  completion  of  
screening  and  tasks,  subjects  will  be  allowed  to  take  frequent  breaks  to  rest  as  needed.  
Patients  will  have  the  option  of  discontinuing  testing  at  any  time,  and  data  that  is  partially  
collected  may  still  be  useful  given  the  preliminary  nature  of  the  study.  Though  unlikely,  it  
is  possible  skin  irritation  might  persist  outside  of  the  testing  period.  Should  this  occur,  the  
patient  would  be  instructed  to  seek  routine  medical  care.  It  is  also  possible  that  there  are  
unknown  risks  for  participating  in  this  study.  
  
11.  Possible  Benefits:  
It  is  possible  that  VTS  might  temporarily  improve  tasks  of  motor  control  or  reduce  
movement  disorders  symptoms.  Subjects  will  also  have  the  satisfaction  of  knowing  that  
they  are  helping  to  test  wearable  devices  that  may  have  potential  as  adjunctive  therapies  
for  movement  disorders  in  a  controlled  unbiased  setting.  
  
12.  Conflict  of  Interest:  
The  study  investigators  have  no  conflicts  of  interest.  
  
  
  
  
  
  
  
  
    

  
  
  
  
References  
1.  
Hess  CW,  Okun  MS.  Diagnosing  Parkinson  Disease.  Continuum  (Minneap  Minn).  
2016;;22(4  Movement  Disorders):1047-­1063.  
2.  
Charcot   JM.   Vibratory   therapeutics.-­-­The   application   of   rapid   and   continuous  
vibrations  to  the  treatment  of  certain  diseases  of  the  nervous  system.  1892.  J  Nerv  
Ment  Dis.  2011;;199(11):821-­827.  
3.  
Gassner  H,  Janzen  A,  Schwirtz  A,  Jansen  P.  Random  Whole  Body  Vibration  over  
5  Weeks  Leads  to  Effects  Similar  to  Placebo:  A  Controlled  Study  in  Parkinson's  
Disease.  Parkinsons  Dis.  2014;;2014:386495.  
4.  
Haas   CT,   Turbanski   S,   Kessler   K,   Schmidtbleicher   D.   The   effects   of   random  
whole-­body-­vibration  
on  
motor  
symptoms  
in  
Parkinson's  
disease.  
NeuroRehabilitation.  2006;;21(1):29-­36.  
5.  
Jobges   EM,   Elek   J,   Rollnik   JD,   Dengler   R,   Wolf   W.   Vibratory   proprioceptive  
stimulation  
affects  
Parkinsonian  
tremor.  
Parkinsonism  
Relat  
Disord.  
2002;;8(3):171-­176.  
6.  
Kapur   SS,   Stebbins   GT,   Goetz   CG.   Vibration   therapy   for   Parkinson's   disease:  
Charcot's  studies  revisited.  J  Parkinsons  Dis.  2012;;2(1):23-­27.  
7.  
King  LK,  Almeida  QJ,  Ahonen  H.  Short-­term  effects  of  vibration  therapy  on  motor  
impairments  in  Parkinson's  disease.  NeuroRehabilitation.  2009;;25(4):297-­306.  
8.  
Grunewald  RA,  Yoneda  Y,  Shipman  JM,  Sagar  HJ.  Idiopathic  focal  dystonia:  a  
disorder  of  muscle  spindle  afferent  processing?  Brain.  1997;;120  (  Pt  12):2179-­
2185.  
9.  
Cussons   PD,   Matthews   PB,   Muir   RB.   Enhancement   by   agonist   or   antagonist  
muscle   vibration   of   tremor   at   the   elastically   loaded   human   elbow.   J   Physiol.  
1980;;302:443-­461.  
10.  
Joshi  R,  Bronstein  JM,  Keener  A,  et  al.  PKG  Movement  Recording  System  Use  
Shows  Promise  in  Routine  Clinical  Care  of  Patients  With  Parkinson's  Disease.  
Front  Neurol.  2019;;10:1027.  
11.  
Goetz  CG,  Tilley  BC,  Shaftman  SR,  et  al.  Movement  Disorder  Society-­sponsored  
revision  of  the  Unified  Parkinson's  Disease  Rating  Scale  (MDS-­UPDRS):  scale  
presentation  and  clinimetric  testing  results.  Mov  Disord.  2008;;23(15):2129-­2170.  
12.  
Zach   H,   Dirkx   MF,   Roth   D,   Pasman   JW,   Bloem   BR,   Helmich   RC.   Dopamine-­
responsive   and   dopamine-­resistant   resting   tremor   in   Parkinson   disease.  
Neurology.  2020;;95(11):e1461-­e1470.  
13.  
Macerollo   A,   Palmer   C,   Foltynie   T,   et   al.   High-­frequency   peripheral   vibration  
decreases   completion   time   on   a   number   of   motor   tasks.   Eur   J   Neurosci.  
2018;;48(2):1789-­1802.  

14.  
Guy   W.   ECDEU   Assessment   Manual   for   Psychopharmacology.   Rockville,   MD:  
U.S.  Department  of  Health,  Education,  and  Welfare;;  1976.  
15.  
Ondo   W,   Hashem   V,   LeWitt   PA,   et   al.   Comparison   of   the   Fahn-­Tolosa-­Marin  
Clinical  Rating  Scale  and  the  Essential  Tremor  Rating  Assessment  Scale.  Mov  
Disord  Clin  Pract.  2018;;5(1):60-­65.  
16.  
Comella   CL,   Stebbins   GT,   Goetz   CG,   Chmura   TA,   Bressman   SB,   Lang   AE.  
Teaching  tape  for  the  motor  section  of  the  Toronto  Western  Spasmodic  Torticollis  
Scale.  Mov  Disord.  1997;;12(4):570-­575.