Using personalized rTMS to help with impulse control disorders

Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study

This study is testing whether a personalized brain treatment can help people with impulse control issues, like overeating, to see if it makes a difference in their lives.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06639594 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility of accelerated repetitive transcranial magnetic stimulation (rTMS) as an adjuvant therapy for individuals with impulse control disorders, specifically focusing on excessive eating. The study will assess recruitment rates, tolerability of the treatment, and safety by monitoring adverse events. Participants will undergo a series of assessments to determine the optimal dosage and duration of rTMS sessions, with the ultimate goal of developing personalized treatment protocols. The study will involve both telehealth and in-person visits to ensure comprehensive participant engagement.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 with a BMI greater than 30 who can follow study instructions and reside stably in the community.

Not a fit: Patients with a history of seizures, neurological disorders, or those who do not meet the safety criteria for EEG and rTMS may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel therapeutic option for individuals struggling with impulse control disorders, potentially improving their quality of life.

How similar studies have performed: While the use of rTMS for various conditions has shown promise, this specific application for impulse control disorders is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age 21 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. Subjects 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. Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry, retainer)
8. Provides written informed consent and agree to all assessments and study procedures.
9. Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.

Exclusion Criteria

1. rTMS exposure for treatment or research purposes in the last 6 months.
2. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
3. 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).
4. History of brain surgery, implanted electronic device, metal in the head.
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)
6. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
7. Reported history of vision problems that are not treated.
8. Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.
9. Reports current diagnosis or history of type I diabetes.
10. Currently using insulin.
11. Have undergone bariatric surgery.
12. Currently being enrolled in a weight loss program
13. Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
14. Self-report a history of or current diagnosis of a mental health condition.
15. Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
16. Reports (\<4 hours of sleep) the day of the visit.
17. Reports using marijuana on a daily basis.
18. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
19. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
20. Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.
21. 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).
    * Medications known to increase risk of seizure taken within 1 week of enrollment.
    * Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix).
22. Being pregnant or lactating
23. Reported allergies to chocolate or any ingredient in the M\&M candies.
24. Noise-induced hearing loss or tinnitus.
25. Currently participating in any other research study.
26. 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
27. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Where this trial is running

Houston, Texas

• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Francesco Versace, PHD,PHD — The Unversity of Texas MD Anderson Cancer Center
• Study coordinator: Francesco Versace, PHD, PHD

Conditions: Impulse Control Disorder