Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT05522803
Eligibility Criteria:
Inclusion Criteria:
1. Seeking to undergo primary (not revisional) bariatric surgery at HH.
2. Be able to give valid informed consent in English.
3. Be 18-60 years of age.
4. Absence of cognitive impairment. Must score below 17 on the adult ADHD self-report scale and have an IQ equivalent of ≥ 80 on the WRAT.
5. Meet clinical criteria regarding hedonic hunger
6. Meet safety criteria for EEG and rTMS.
7. Eat a typical breakfast before 8:00 AM on the day of screening.
Exclusion Criteria:
1. History of any neurological disorder that would increase seizure risk from rTMS such as stroke, brain lesions, previous neurosurgery, any history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month.
2. First-degree family history of epilepsy, schizophrenia, and bipolar disorder, neurological disorders with a potentially hereditary basis that affect rTMS safety or EEG measures.
3. 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 that precludes rTMS administration.
4. Noise-induced hearing loss or tinnitus.
5. Current use of any investigational drug or of anti or pro-convulsive action. Use of medications with psychotropic (e.g., benzodiazepines) effects that is not currently stabilized or with disease symptoms present.
6. Lifetime history of schizophrenia, bipolar disorder, mania, or hypomania.
7. History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, and currently under medical care.
8. Participation in any rTMS session less than 2 weeks prior to admission. No rTMS exposure for treatment purposes in the last 6 months.
9. Pregnant women.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05522803
Study Brief:
Protocol Section:
NCT05522803