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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-21

Study Completion Date

2027-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of rTMS on Food Choice in Anorexia Nervosa

NCT05918835

Anorexia Nervosa

ACTIVE_NOT_RECRUITING NA

The Effectiveness of rTMS on Improving Food Craving and Weight Control in Adults Without Serious Mental Illness

NCT07106398

Food Cravings rTMS

RECRUITING NA

Transcranial Magnetic Stimulation for Treatment of Methamphetamine Use Disorder

NCT03736317

Amphetamine Use Disorders

COMPLETED NA

Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus

NCT03515408

Attention Deficit Hyperactivity Disorder

COMPLETED NA

Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression

NCT00521352

Panic Disorder Major Depressive Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impulse Control Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent theta burst stimulation

Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive continuous theta burst stimulation (cTBS) for 3 sessions; in week 2 participants receive intermittent theta burst stimulation (iTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil.

Continuous theta burst stimulation

Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive continuous theta burst stimulation (cTBS) for 3 sessions; in week 2 participants receive intermittent theta burst stimulation (iTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repetitive Transcranial Magnetic Stimulation (rTMS)

RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No