Home-based tDCS for Prevention of Suicidal Ideation (NCT05280756) | Clinical Trial Compass
CompletedNot Applicable
Home-based tDCS for Prevention of Suicidal Ideation
United States33 participantsStarted 2023-09-21
Plain-language summary
Risk for suicide is elevated in the period after discharge from hospital among adults with major affective disorder. The primary objective of this study is to investigate the feasibility of delivering tDCS sessions for high-risk patients for suicide at home in the days following discharge from an emergency department or inpatient unit. This is a single-center, randomized, sham-controlled, double-blind clinical study. We plan to assess up to 80 adult patients for eligibility over 12 months of which 20 will be enrolled and randomized. Clinical assessments will be performed at baseline, post-treatment day 14 (14 days after the first tDCS session), and follow-up day 30 and 60 (30 and 60 days after the first tDCS session, respectively).
Who can participate
Age range
18 Years – 65 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:
* age between 18 and 65 years
* diagnosis of mood or bipolar disorder registered in the electronic hospital medical record
* history of suicidal ideation and/or suicidal behavior at the time of admission registered in the electronic hospital medical record
* absent of suicidal ideation at the time of enrollment (defined as questions 1 and 2 of the C-SSRS answered "no")
* ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up
* a living situation with access to a private space suitable for the administration of the RS-tDCS sessions in the next three weeks
* agree to use a medically acceptable form of birth control while receiving the treatment if you are an individual able to become pregnant
* living in Monroe County region, as this is the area covered by the Mobile Crisis Team, a URMC psychiatric emergency team serving anyone within Monroe County
* device or computer with internet access for a URMC-approved remote RS-tDCS supervision
* ability to manage proper use of the device in a practice session
Exclusion Criteria:
* acute psychiatric instability or substance abuse (e.g., psychotic symptoms, alcohol misuse in the previous three months, use of any illicit drugs in the previous three months)
* unstable medical condition with reduction of functional capacity
* history of epilepsy or seizures in the last y…
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
Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions