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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT04784494
Eligibility Criteria:
Inclusion Criteria:
1. Are outpatient or inpatient persons capable of providing informed consent;
2. ≥50 years old;
3. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria;
4. Hoehn and Yahr stage between 1-4;
5. MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0.) diagnosis of a current major depressive episode;
6. IDS score of ≥22 (moderate/severe depression);
7. Are on stable doses of psychotropic medication;
8. Are considered to be appropriate to receive convulsive therapy as assessed by an attending psychiatrist and a consultant anaesthesiologist;
9. Patient may or may not be on antidepressant medication, but If on antidepressant medication, they should be agreeable to keep their current antidepressant treatment constant during the intervention;
10. are able to adhere to the intervention schedule;
11. meet the MST safety criteria;
Exclusion Criteria:
1. Current diagnosis of major neurocognitive disorder other than PD (eg. Multiple System Atrophy, Lewy Body Dementia) or dementia (Montreal Cognitive Assessment (MoCA) \<21)
2. Current active psychosis;
3. Have any of the cardiovascular risk factors listed on the Revised Cardiac Risk Index Score
4. Unstable medical conditions that, in the opinion of the Principal Investigator, carries significant risk of exacerbation by either of the study interventions;
5. Psychotropic medication initiation \<4 weeks prior to enrolment (two classes, antiparkinsonsian and antidepressant compounds);
6. Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
7. Require a benzodiazepine dose \> 2mg/day of lorazepam or equivalent dose or are on any anticonvulsant due to the potential of these medications to limit the efficacy of MST;
8. Are unable to communicate in English fluently enough to complete the neuropsychological tests;
9. Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
10. Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04784494
Study Brief:
Protocol Section:
NCT04784494