Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation (NCT06429748) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation
United States20 participantsStarted 2024-05-15
Plain-language summary
A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.
Who can participate
Age range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults, 22 to 70 years of age
. Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
. Score \> or = 8 on ISI scale
. If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
. If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
. Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.
Exclusion criteria
. Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
. History of head trauma associated with loss of consciousness or diagnosed as concussion.
. History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in multiple symptoms after rTMS treatment.
. Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
. Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
. Has medication infusion device.
. Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
. PHQ-9 total score \> or = 10 or QIDS total score \> or = 11.