Clinical trial NCT06639594: Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
Official title: Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Impulse Control Disorder
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.

Detailed description: Primary Objectives:

To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:

-Recruitment: We will define recruitment as the probability of an eligible participant consenting to participate in the study.

We will deem recruitment for this trial feasible if at least 70% of eligible participant consent to participate in the trial. (i.e., considering a pool of 30 eligible participant, we consent at least 21 participants).

* Tolerability: For each protocol, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS protocol.
* Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.

Secondary Objectives

We will measure:

1. To measure the time required to the staff to conduct each ERP assessment.
2. To measure the time between the end of the last rTMS session and the start of the second ERP assessment.

   We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
3. We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 60
2. BMI\>30 (confirmed at in person visit)
3. Able to follow verbal and written instructions in English and complete all aspects of the study.
4. Have an address and telephone number where they may be reached.
5. Participants must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
6. Meet safety criteria for EEG and rTMS.
7. Provides written informed consent and agree to all assessments and study procedures.
8. Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.

Exclusion Criteria

1. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness lasting over 15 minutes or with sequelae lasting longer than one week
2. Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
3. History of brain surgery, implanted electronic device, metal in the head.
4. First-degree family history of epilepsy, schizophrenia, depression, or bipolar disorder.
5. Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body.
6. rTMS exposure for treatment or research purposes in the last 6 months.
7. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
8. Reports current diagnosis or history of type I diabetes.
9. Currently using insulin.
10. Self-report a history or current diagnosis of schizophrenia or bipolar disorder unless cleared by study physician.
11. Self-report of a history or current diagnosis of post-traumatic stress disorder or eating disorder unless cleared by study physician.
12. Current Substance Use Disorder (DAST score \>3 or use \>0 in the past year and refuses to refrain from use for the duration of the study; USAUDIT score \>15)
13. Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
14. Individuals who report anxiety symptoms in the severe range on the GAD-7 (scores of 15 or above); or meet criteria for Panic Syndrome on the PHQ Panic module.
15. Psychiatric hospitalization or suicidal ideation within 1 year of screening date
16. Currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
17. Use of marijuana or other illicit drugs in the last 3 months.
18. Current or recent use (last 3 months) of smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix) or nicotine replacement therapy.
19. Have undergone bariatric surgery.
20. Currently being enrolled in a weight loss program
21. Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
22. Severe insomnia (\<4 hours sleep per night with hypnotic)
23. Sleep Deprived (\<4 hours of sleep) the day of the visit
24. Current use of certain medications (last 3 months):

    * Investigational drugs.
    * Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).
25. Medications known to increase risk of seizure taken within 1 week of enrollment
26. Being pregnant or lactating (as determined by participant self-report).
27. Reported allergies to chocolate or any ingredient in the M\&M candies.
28. Noise-induced hearing loss or tinnitus.
29. Reported history of vision problems that are not treated.
30. Has a hairstyle not compatible with the EEG and unwilling to modify hairstyle (e.g., braids, ponytails, dreadlocks, non-removable hair extensions or wigs, etc.) to accommodate the EGG net that is required to be worn on the scalp during the experimental procedure
31. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician
32. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Primary outcomes:
measure: Safety and Adverse Events (AEs).
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The Unversity of Texas MD Anderson Cancer Center
name: Francesco Versace, PHD,PHD
role: PRINCIPAL_INVESTIGATOR
References: