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:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03276793
Eligibility Criteria:
Inclusion Criteria:
1. Male or female
2. Aged 18 or older
3. Have previously received or will once daily TMS treatment to the left dorsolateral prefrontal cortex at the Center for Brain Circuit Therapeutics at Brigham and Women's Hospital, or at Massachusetts General Hospital for treatment of medication resistant depression
Exclusion Criteria:
1. Presence of a significant neurologic disorder (i.e. Parkinson's Disease, stroke, Alzheimer's Disease, tumor, multiple sclerosis, epilepsy) or other significant active medical problems which may impact treatment or safety. Of note, many of these are also contraindications to receiving TMS and these patients would not be enrolled in the clinical treatment program. Because these diagnoses, their significance, and the extent to which they are an active issue can be subjective, each of these exclusions (1-3) will be reviewed by the PI or study physician
2. Lack of response to an adequate trial of electroconvulsive therapy (ECT) or any ECT in the preceding 3 months
3. Prior adequate trial of TMS treatment in the last 12 months
4. Positive MRI screen that would preclude the subject from undergoing magnetic resonance imaging. These include, but are not limited to any of the following:
1. Known metal in the head (such as a surgical aneurysm clip), or a history of prior neurosurgical procedures
2. Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic means such as: cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, biostimulators, or ventriculo-peritoneal shunts
3. Subjects who have or might have bullet fragments or other metal fragments (veterans or workers exposed to metal in their work environment)
4. Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
5. Subjects expressing significant anxiety or claustrophobia about being in the magnet.
5. Subjects that cannot adhere to the experimental protocol for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03276793
Study Brief:
Protocol Section:
NCT03276793