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Suicidal IdeationNCT05280756

Home-based tDCS for Prevention of Suicidal Ideation

A study testing Home-based transcranial direct current stimulation (tDCS) in people with Suicidal Ideation, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Suicidal Ideation
What is being tested?
Home-based transcranial direct current stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteUnited States
Study dates
21 Sep 2023to 11 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

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

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).

Being tested
Home-based transcranial direct current stimulation (tDCS), Sham home-based transcranial direct current stimulation (tDCS)
Medical subject headings
Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) 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)Device

    Also called Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) 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.

Study groups in NCT05280756
Study groupRoleWhat they receive
Active home-based transcranial direct current stimulation (tDCS)ExperimentalThe 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.
Receives: Device: Home-based transcranial direct current stimulation (tDCS)
Sham home-based transcranial direct current stimulation (tDCS)Sham comparatorThe 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.
Receives: Device: Sham home-based transcranial direct current stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 14 days after start of treatment

Secondary outcomes (18)
  1. Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 14

    The C-SSRS (Columbia-Suicide Severity Rating Scale) is a suicidal ideation and behavior rating scale. For the 5 items assessing suicidal ideation intensity, each item is scored 0-5. The total intensity score is the sum of these 5 items (range 0-25), with higher scores indicating greater suicidal ideation. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants

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

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

    The C-SSRS (Columbia-Suicide Severity Rating Scale) is a suicidal ideation and behavior rating scale. For the 5 items assessing suicidal ideation intensity, each item is scored 0-5. The total intensity score is the sum of these 5 items (range 0-25), with higher scores indicating greater suicidal ideation. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants

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

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

    Outcome measure description: The C-SSRS (Columbia-Suicide Severity Rating Scale) is a suicidal ideation and behavior rating scale. For the 5 items assessing suicidal ideation intensity, each item is scored 0-5. The total intensity score is the sum of these 5 items (range 0-25), with higher scores indicating greater suicidal ideation. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants

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

  4. Acceptability of the Intervention as Assessed by Participant-reported Questionnaire

    Acceptability of the intervention is assessed based on participants' readiness, self-confidence, and satisfaction with treatment. Specifically, acceptability is determined if at least 60% of participants respond "Strongly agree" or "Agree" to item 11 of the acceptability questionnaire: "Overall, I felt that transcranial electrical stimulation treatment benefited me." The questionnaire uses a 5-point Likert scale: "Strongly agree," "Agree," "Neither agree nor disagree," "Disagree," "Strongly disagree." Higher scores indicate greater perceived acceptability.

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

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

    Proportion of participants who report no suicidal ideation, defined as answering "No" to both question 1 ("Have you wished you were dead or wished you could go to sleep and not wake up?") and question 2 ("Have you actually had any thoughts of killing yourself?") on the C-SSRS. Higher proportions indicate fewer participants experiencing suicidal ideation.

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

  6. Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS

    Proportion of participants who report no suicidal ideation, defined as answering "No" to both question 1 ("Have you wished you were dead or wished you could go to sleep and not wake up?") and question 2 ("Have you actually had any thoughts of killing yourself?") on the C-SSRS. Higher proportions indicate fewer participants experiencing suicidal ideation

    Measured: day 30 [+ 7 days] from the first RS-tDCS session

  7. Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS

    Proportion of participants who report no suicidal ideation, defined as answering "No" to both question 1 ("Have you wished you were dead or wished you could go to sleep and not wake up?") and question 2 ("Have you actually had any thoughts of killing yourself?") on the C-SSRS. Higher proportions indicate fewer participants experiencing suicidal ideation.

    Measured: day 60 [+ 10 days] from the first RS-tDCS session

  8. Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 14

    The Ruminative Responses Scale (RRS) is a 22-item self-report measure assessing rumination. Each item is rated on a 4-point Likert scale: 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. The total score is calculated by summing the scores of all 22 items (range 22-88), with higher scores indicating greater rumination. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants

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

  9. Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 30

    The Ruminative Responses Scale (RRS) is a 22-item self-report measure assessing rumination. Each item is rated on a 4-point Likert scale: 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. The total score is calculated by summing the scores of all 22 items (range 22-88), with higher scores indicating greater rumination. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants

    Measured: day 30 [+ 7 days] from the first RS-tDCS session

  10. Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 60

    The Ruminative Responses Scale (RRS) is a 22-item self-report measure assessing rumination. Each item is rated on a 4-point Likert scale: 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. The total score is calculated by summing the scores of all 22 items (range 22-88), with higher scores indicating greater rumination. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants

    Measured: day 60 [+ 10 days] from the first RS-tDCS session

  11. Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 14

    The Concise Associated Symptoms Tracking (CAST) scale is a 16-item self-report measure assessing symptoms associated with suicidal ideation across five domains: anxiety (3 items, subscore range 3-15), irritability (5 items, subscore range 5-25), mania (4 items, subscore range 4-20), insomnia (2 items, subscore range 2-10), and panic (2 items, subscore range 2-10). Total CAST scores range from 16 to 80. Each item is rated on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree. Higher scores indicate greater symptom severity. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants

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

  12. Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 30

    The Concise Associated Symptoms Tracking (CAST) scale is a 16-item self-report measure assessing symptoms associated with suicidal ideation across five domains: anxiety (3 items, subscore range 3-15), irritability (5 items, subscore range 5-25), mania (4 items, subscore range 4-20), insomnia (2 items, subscore range 2-10), and panic (2 items, subscore range 2-10). Total CAST scores range from 16 to 80. Each item is rated on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree. Higher scores indicate greater symptom severity. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants

    Measured: day 30 [+ 7 days] from the first RS-tDCS session

  13. Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 60

    The Concise Associated Symptoms Tracking (CAST) scale is a 16-item self-report measure assessing symptoms associated with suicidal ideation across five domains: anxiety (3 items, subscore range 3-15), irritability (5 items, subscore range 5-25), mania (4 items, subscore range 4-20), insomnia (2 items, subscore range 2-10), and panic (2 items, subscore range 2-10). Total CAST scores range from 16 to 80. Each item is rated on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree. Higher scores indicate greater symptom severity. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants

    Measured: day 60 [+ 10 days] from the first RS-tDCS session

  14. Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 14

    MADRS is a 10-item clinician-administered questionnaire assessing the following symptoms: 1) Apparent sadness, 2) Reported sadness, 3) Inner tension, 4) Reduced sleep, 5) Reduced appetite, 6) Concentration difficulties, 7) Lassitude, 8) Inability to feel, 9) Pessimistic thoughts, 10) Suicidal thoughts. Each item is scored 0-6, giving a total score range of 0-60. Higher scores indicate more severe depressive symptoms. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants

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

  15. Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 30

    MADRS is a 10-item clinician-administered questionnaire assessing the following symptoms: 1) Apparent sadness, 2) Reported sadness, 3) Inner tension, 4) Reduced sleep, 5) Reduced appetite, 6) Concentration difficulties, 7) Lassitude, 8) Inability to feel, 9) Pessimistic thoughts, 10) Suicidal thoughts. Each item is scored 0-6, giving a total score range of 0-60. Higher scores indicate more severe depressive symptoms. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants

    Measured: day 30 [+ 7 days] from the first RS-tDCS session

  16. Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 60

    MADRS is a 10-item clinician-administered questionnaire assessing the following symptoms: 1) Apparent sadness, 2) Reported sadness, 3) Inner tension, 4) Reduced sleep, 5) Reduced appetite, 6) Concentration difficulties, 7) Lassitude, 8) Inability to feel, 9) Pessimistic thoughts, 10) Suicidal thoughts. Each item is scored 0-6, giving a total score range of 0-60. Higher scores indicate more severe depressive symptoms. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants

    Measured: day 60 [+ 10 days] from the first RS-tDCS session

  17. Mean Cumulative Side Effect Score Per Participant Across RS tDCS Sessions

    After each RS tDCS session (up to 10 sessions per participant), seven prespecified side effects itching, burning, headache, fatigue, nervousness, dizziness, and difficulty concentrating were assessed using the RS tDCS Side Effect Rating Scale. Each symptom was rated on a numeric scale from 0 to 10, where 0 indicates not at all and 10 indicates the highest degree of severity.

    For each participant and each symptom, ratings were summed across all completed sessions to generate a cumulative symptom specific side effect score, with a theoretical range of 0 to 100. Higher scores indicate greater cumulative side effect burden. Participants contributed all available session ratings with no imputation. For reporting, participant level cumulative scores were averaged across participants for each symptom and summarized as mean and standard deviation.

    Measured: Assessed after each RS-tDCS session; values reported represent the average and summarized across all sessions completed during the 4-week treatment period

  18. Number of Participants Reporting Solicited Side Effects During RS tDCS Treatment

    Predefined, expected side effects associated with RS tDCS were prospectively and systematically collected using a standardized post session side effect questionnaire administered after each RS tDCS session. Solicited side effects included itching, burning, headache, fatigue, nervousness, dizziness, difficulty concentrating, and other expected sensations related to stimulation.

    This outcome summarizes the number of participants who reported one or more solicited side effects at any time during the treatment period. These solicited side effect assessments were collected as part of structured safety monitoring and are reported as outcome measures rather than as adverse events. Unsolicited adverse events meeting ClinicalTrials.gov reporting criteria are reported separately in the Adverse Events module.

    Measured: Assessed after each RS tDCS session during the 4 week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start21 Sep 2023
  3. Primary completion24 Apr 2024
  4. Study completion11 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280756
Sponsor's protocol ID
STUDY00008028
Status last verified
Jan 2026
First submitted
4 Mar 2022
Last updated
6 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: We are investigating options for making unidentifiable research data from individual participants available for public sources such as Harvard Dataverse.

Questions about this trial

What is this clinical trial studying?

A study testing Home-based transcranial direct current stimulation (tDCS) in people with Suicidal Ideation, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions (time frame: 14 days after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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