Home-based tDCS for Prevention of Suicidal Ideation

NCT ID: NCT05280756

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-06-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Active home-based transcranial direct current stimulation (tDCS)

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.

Group Type: EXPERIMENTAL

Home-based transcranial direct current stimulation (tDCS)

Intervention Type: 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.

Sham home-based transcranial direct current stimulation (tDCS)

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.

Group Type: SHAM_COMPARATOR

Sham home-based transcranial direct current stimulation (tDCS)

Intervention Type: 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.

Interventions

Sham home-based transcranial direct current stimulation (tDCS)

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.

Intervention Type: DEVICE

Home-based transcranial direct current stimulation (tDCS)

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.

Intervention Type: DEVICE

Other Intervention Names

Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) device; Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) device

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brain & Behavior Research Foundation

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Yeates Conwell, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yeates Conwell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STUDY00008028

Identifier Type: -

Identifier Source: org_study_id