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New treatment option for Impulse Control Disorder
Official title Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
ClinicalTrials.gov ID: NCT06639594
What this study is testing
- What it's testing
- To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 60
You may be able to join if
- Age 21 to 60
- BMI\>30 (confirmed at in person visit)
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
- people must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and...
You likely can't join if
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis...
- History of brain surgery, implanted electronic device, metal in the head.
- Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable...
- History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic...
See the full eligibility criteria
Who can join
- Age 21 to 60
- BMI\>30 (confirmed at in person visit)
- Able to follow verbal and written instructions in English and complete all aspects of the study.
- Have an address and telephone number where they may be reached.
- people 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...
- Meet safety criteria for EEG and rTMS.
- Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry, retainer)
- Provides written informed consent and agree to all assessments and study procedures.
- Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.
What rules you out
- rTMS exposure for treatment or research purposes in the last 6 months.
- History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
- 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).
- History of brain surgery, implanted electronic device, metal in the head.
- 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...
- History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
- Reported history of vision problems that are not treated.
- Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.
- Reports current diagnosis or history of type I diabetes.
- Currently using insulin.
- Have undergone bariatric surgery.
- Currently being enrolled in a weight loss program
- Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
- Self-report a history of or current diagnosis of a mental health condition.
- Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
- Reports (\<4 hours of sleep) the day of the visit.
- Reports using marijuana on a daily basis.
- Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
- Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
- 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.
- 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).
- Being pregnant or lactating
- Reported allergies to chocolate or any ingredient in the M\&M candies.
- Noise-induced hearing loss or tinnitus.
- Currently participating in any other research study.
- 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...
- people considered by the investigator as unsuitable for the study for reasons not otherwise stated.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.