Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
RAPID
2 other identifiers
interventional
30
1 country
1
Brief Summary
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 3, 2027
March 23, 2026
March 1, 2026
3 years
October 10, 2024
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year.
Study Arms (2)
Intermittent theta burst stimulation
EXPERIMENTALParticipants undergo rTMS once a week for 2 weeks. In week 1 participants receive intermittent theta burst stimulation (iTBS)" for 3 sessions; in week 2 participants receive continuous theta burst stimulation ciTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study.
Continuous theta burst stimulation
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify 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.
- 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.
- 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.
You may not qualify 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, 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, stimulators, cochlear implants, or electrodes)
- 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)
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Versace, PHD,PHD
The Unversity of Texas MD Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2024
First Posted
October 15, 2024
Study Start
November 21, 2024
Primary Completion (Estimated)
November 3, 2027
Study Completion (Estimated)
November 3, 2027
Last Updated
March 23, 2026
Record last verified: 2026-03