RecruitingPhase 1

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

United States30 participantsStarted 2024-11-21

Plain-language summary

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

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Safety and Adverse Events (AEs).

Timeframe: Through study completion; an average of 1 year.

NCT IDNCT06639594

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-03

Francesco Versace, PHD, PHD

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.