NCT05280756

Home-based tDCS for Prevention of Suicidal Ideation

Home-based Transcranial Direct-current Stimulation (tDCS) for Prevention of Suicidal Ideation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2023-09-21
• Primary completion: 2024-04-24
• Completion: 2024-06-11
• First posted: 2022-03-15
• Last updated: 2026-02-06
• Results posted: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study