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.
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.
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).
- Conditions
- Suicidal Ideation
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted15 Mar 2022
- Study start21 Sep 2023
- Primary completion24 Apr 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Yeates Conwell, MD, University of Rochester
- Investigators
- Yeates Conwell, MD, Principal investigator, University of Rochester
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Transcranial Direct-current Stimulation (tDCS) for Prevention of Suicidal Ideation
- ClinicalTrials.gov ID
- NCT05280756
- Acronym / sponsor ID
- STUDY00008028
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active home-based transcranial direct current stimulation (tDCS) | Experimental | Device: 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. |
| Sham home-based transcranial direct current stimulation (tDCS) | Sham comparator | Device: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based transcranial direct current stimulation (tDCS)Also: Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) deviceEach 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 | Active home-based transcranial direct current stimulation (tDCS) |
| Sham home-based transcranial direct current stimulation (tDCS)Also: Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) deviceEach 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. | Device | Sham home-based transcranial direct current stimulation (tDCS) |
Primary outcome
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
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.
18 secondary outcomes
Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 14
Time frame: 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
Time frame: 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
Time frame: Day 60 (± 10 days) from the first RS-tDCS session
Acceptability of the Intervention as Assessed by Participant-reported Questionnaire
Time frame: 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)
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 14
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 30
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 60
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 14
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 30
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 60
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 14
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 30
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 60
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Mean Cumulative Side Effect Score Per Participant Across RS tDCS Sessions
Time frame: Assessed after each RS-tDCS session; values reported represent the average and summarized across all sessions completed during the 4-week treatment period
Number of Participants Reporting Solicited Side Effects During RS tDCS Treatment
Time frame: Assessed after each RS tDCS session during the 4 week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. We are investigating options for making unidentifiable research data from individual participants available for public sources such as Harvard Dataverse.
Related trials for Suicidal Ideation
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department.
Suicidal Ideas, Suicidal Ideation
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeates Conwell, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
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.