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Search / Trial NCT06639594

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

Launched by M.D. ANDERSON CANCER CENTER · Oct 10, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called accelerated repetitive transcranial magnetic stimulation (rTMS) to see if it can help people who struggle with impulse control disorders, like excessive eating. The study aims to find out if this therapy can be effective and is currently looking for participants aged 18 to 60 with a body mass index (BMI) over 30. Eligible participants should be able to follow instructions in English and have a stable home address. They’ll also need to agree to attend both virtual and in-person visits.

If you decide to participate, you can expect to undergo a series of assessments and receive the rTMS treatment in a safe environment. However, there are some important health criteria to consider. For example, individuals with a history of seizures, certain neurological disorders, or specific heart conditions cannot take part in the study. It’s essential to review the full eligibility criteria to ensure you qualify. This trial aims to provide valuable insights into a potential new therapy for impulse control disorders, which could benefit many individuals in the future.

Gender

ALL

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.

About M.D. Anderson Cancer Center

The University of Texas MD Anderson Cancer Center is a leading institution dedicated to cancer care, research, education, and prevention. As one of the world’s most respected cancer centers, MD Anderson focuses on innovative treatment approaches and groundbreaking clinical trials aimed at improving patient outcomes. With a multidisciplinary team of experts and state-of-the-art facilities, the center is committed to advancing cancer research and providing comprehensive, personalized care to patients. MD Anderson's clinical trials play a pivotal role in translating scientific discoveries into effective therapies, positioning the center at the forefront of cancer treatment and research.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Francesco Versace, PHD,PHD

Principal Investigator

The Unversity of Texas MD Anderson Cancer Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported