N/A
N=9
Home-based tDCS for Prevention of Suicidal Ideation
Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT05280756 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-based transcranial direct current stimulation (tDCS) (Device); Sham home-based transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions |
4; 3 | — |
| SECONDARY Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 14 |
8.25; 6.33 | — |
| SECONDARY Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 30 |
9.00; 7.33 | — |
| SECONDARY Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 60 |
6.50; 10.00 | — |
| SECONDARY Acceptability of the Intervention as Assessed by Participant-reported Questionnaire |
2; 1 | — |
| SECONDARY Proportion of Patients With no Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) |
2; 2 | — |
| SECONDARY Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS |
1; 1 | — |
| SECONDARY Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS |
1; 1 | — |
| SECONDARY Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 14 |
58.25; 63.33 | — |
| SECONDARY Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 30 |
54; 52 | — |
| SECONDARY Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 60 |
51; 55 | — |
| SECONDARY Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 14 |
45.5; 47.33 | — |
| SECONDARY Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 30 |
42.25; 46.67 | — |
| SECONDARY Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 60 |
44.75; 45 | — |
| SECONDARY Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 14 |
20.25; 30.67 | — |
| SECONDARY Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 30 |
20.33; 25.33 | — |
| SECONDARY Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 60 |
22; 18.67 | — |
| SECONDARY Mean Cumulative Side Effect Score Per Participant Across RS tDCS Sessions |
14.00; 12; 33.00; 13.33; 13.25; 8.67 | — |
| SECONDARY Number of Participants Reporting Solicited Side Effects During RS tDCS Treatment |
2; 1 | — |
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).
Eligibility Criteria
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 year
- history of neurodegenerative diseases registered in the electronic hospital medical record
- presence of or implanted any ferromagnetic metal in the head or the neck
- pregnant or breastfeeding or willingness to become pregnant in the next month
- history of head trauma (e.g., head injury, brain injury) or neurosurgery
- history of skin disorder or sensitive skin area near stimulation locations
- the presence of pacemaker
- current treatment with electroconvulsive therapy or transcranial magnetic stimulation
Data sourced from ClinicalTrials.gov (NCT05280756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.