Home-based tDCS for Prevention of Suicidal Ideation

NCT05280756 | Completed Results FDA Device

• 1 other identifier: STUDY00008028
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions

  Number of completed remotely supervised transcranial direct current stimulation (RS-tDCS) sessions, for both active and sham groups: We expect at least 70% of the subjects to complete at least 5 of recommended 10 RS-tDCS sessions.

  14 days after start of treatment

Secondary Outcomes (18)

• Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 14

  day 14 [+ 7 days] from the first RS-tDCS session

• Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 30

  Day 30 (± 7 days) from the first RS-tDCS session

• Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 60

  Day 60 (± 10 days) from the first RS-tDCS session

• Acceptability of the Intervention as Assessed by Participant-reported Questionnaire

  Collected after the final RS-tDCS session (tenth session)

• Proportion of Patients With no Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

  day 14 [+ 7 days] from the first RS-tDCS session

Study Arms (2)

Active home-based transcranial direct current stimulation (tDCS)

EXPERIMENTAL

The active home-based tDCS delivers a constant current intensity of 2mA on the subject's scalp, with electrodes positioned bilaterally (anodal-left and cathodal-right), on the dorsolateral prefrontal cortex (DLPFC), for 30 minutes.

Device: Home-based transcranial direct current stimulation (tDCS)

Sham home-based transcranial direct current stimulation (tDCS)

SHAM COMPARATOR

The sham home-based tDCS looks identical to a typical active home-based tDCS cap but delivers a 30-second ramp-up (0-2 mA) stimulation followed by a 30-second ramp-down (2-0 mA) at the beginning and end of the application.

Device: Sham home-based transcranial direct current stimulation (tDCS)

Interventions

Sham home-based transcranial direct current stimulation (tDCS) DEVICE

Each participant will be asked to do ten home-based sessions, one per weekday, during two weeks (Monday to Friday). Each session will be supervised remotely by a member of the research staff via HIPAA-compliant videoconference. Participants will receive sham home-based tDCS for 30 minutes per session daily for 2 weeks (Monday to Friday - 10 sessions overall) via a tDCS stimulator with headgear and 5x7 (35cm2) saline-soaked surface sponge electrodes.

Also known as: Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) device

Sham home-based transcranial direct current stimulation (tDCS)

Home-based transcranial direct current stimulation (tDCS) DEVICE

Each participant will be asked to do ten home-based tDCS sessions, one per weekday, during two weeks (Monday to Friday). Each session will be supervised remotely by a member of the research staff via HIPAA-compliant videoconference. Participants will receive active home-based tDCS (constant current intensity of 2mA) anodal-left and cathodal-right prefrontal for 30 minutes per session daily for 2 weeks (Monday to Friday - 10 sessions overall) via a tDCS stimulator with headgear and 5x7 (35cm2) saline-soaked surface sponge electrodes.

Also known as: Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) device

Active home-based transcranial direct current stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brain & Behavior Research Foundation: collaborator
• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Alexandre Paim Diaz
• Organization: University of Pittsburgh Medical Center

paimdiaza@upmc.edu

(412) 624-1000

Study Officials

• Yeates Conwell, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: September 21, 2023
• Primary Completion: April 24, 2024
• Study Completion: June 11, 2024
• Last Updated: February 6, 2026
• Results First Posted: May 7, 2025

Record last verified: 2026-01

Locations

US (1)