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Behavioural Intervention

Home-Based Brain Stimulation for Suicidal Thoughts

N/A

Recruiting

Led By Yeates Conwell, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 65 years

Diagnosis of mood or bipolar disorder registered in the electronic hospital medical record

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the level of side effects will be assessed at the end of each rs-tdcs session and at days 14 [+ 7 days], 30 [+ 7 days], and 60 [+ 10 days] from the first rs-tdcs session

Awards & highlights

Study Summary

This trial is testing whether a home-based brain stimulation protocol can help reduce suicidality and suicidal ideation in adult patients after discharge from a psychiatric hospitalization. The hypothesis is that home-based tDCS will be successfully implemented, well tolerated, and produce high user satisfaction, and participants will be unable to differentiate home-based tDCS from sham home-based tDCS.

Who is the study for?

Adults aged 18-65 with mood or bipolar disorders, living in Monroe County with internet access and a private space for treatment. They must have had suicidal thoughts at admission but not at enrollment, and be able to use the tDCS device after training. Excluded are those with unstable health, skin conditions near stimulation sites, neurodegenerative diseases, recent seizures or substance abuse issues.Check my eligibility

What is being tested?

The study tests if home-based tDCS can prevent suicidal thoughts post-hospital discharge. It's a double-blind trial where half of the participants will receive real tDCS and half sham (fake) treatment over two weeks, followed by assessments on day 14, 30 and 60.See study design

What are the potential side effects?

tDCS is generally well-tolerated but may cause mild side effects like itching or tingling at the electrode site during application; headache; fatigue; nausea; or insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My medical records show a diagnosis of mood or bipolar disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the level of side effects will be assessed at the end of each rs-tdcs session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the level of side effects will be assessed at the end of each rs-tdcs session

This trial's timeline: 3 weeks for screening, Varies for treatment, and the level of side effects will be assessed at the end of each rs-tdcs session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of the intervention

Secondary outcome measures

Acceptability of the intervention

Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Intensity of rumination as assessed by the Ruminative Responses Scale (RRS)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active home-based transcranial direct current stimulation (tDCS)Experimental Treatment1 Intervention

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 II: Sham home-based transcranial direct current stimulation (tDCS)Placebo Group1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,940 Total Patients Enrolled

University of RochesterLead Sponsor

840 Previous Clinical Trials

534,230 Total Patients Enrolled

Brain & Behavior Research FoundationOTHER

61 Previous Clinical Trials

2,793 Total Patients Enrolled

Media Library

Home-based tDCS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05280756 — N/A

Suicidal Thoughts Research Study Groups: Active home-based transcranial direct current stimulation (tDCS), Sham home-based transcranial direct current stimulation (tDCS)

Suicidal Thoughts Clinical Trial 2023: Home-based tDCS Highlights & Side Effects. Trial Name: NCT05280756 — N/A

Home-based tDCS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280756 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollees currently being welcomed into this investigation?

"As of now, this clinical trial is actively searching for volunteers. It was initially made available on November 15th 2021 and the most recent edit was completed on March 4th 2022."

Answered by AI

Is enrollment for this study limited to individuals aged 50 and under?

"This study is seeking individuals between the age of 18 and 65 to participate."

Answered by AI

To whom is this research opportunity available?

"In this trial, 20 adults aged 18 to 65 with suicidal ideations will be enrolled. To qualify for participation they must have a DSM-5 admission diagnosis of major depression or bipolar disorder related to suicidal behavior (verified through medical record review). Additionally, participants should score 0 - 1 on the Montgomery-Asberg Depression Rating Scale item 10 at screening and remain in standard outpatient psychiatric care throughout the duration of the research."

Answered by AI

What is the current participant quota for this trial?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial is enrolling participants, with the initial posting on November 15th 2021 and most recent update being March 4th 2022. The study requires 20 people across one site to partake in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Home-based tDCS for Prevention of Suicidal Ideation

Yeates Conwell, MD 2023. "Home-based tDCS for Prevention of Suicidal Ideation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280756.