Home-based tDCS for Prevention of Suicidal Ideation

Not Applicable

Completed

Conditions: Suicidal Ideation

Interventions: Device: Sham home-based transcranial direct current stimulation (tDCS)
Device: Home-based transcranial direct current stimulation (tDCS)

Registration Number: NCT05280756

Lead Sponsor: University of Rochester

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham home-based transcranial direct current stimulation (tDCS)	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.
Active home-based transcranial direct current stimulation (tDCS)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions	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.

Secondary Outcome Measures

Name	Time	Method
Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)	day 60 [+ 10 days] from the first RS-tDCS session	The RRS encompasses 22 items. Each item is rated on a 4-point Likert scale: 1, almost never; 2, sometimes; 3, often; 4, almost always. The score on this scale is obtained by simply summing the scores on the 22 items.
Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	day 60 [+ 10 days] from the first RS-tDCS session	The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25), with higher scores indicating more severe suicidal ideation.
Acceptability of the Intervention	This information will be collected after the final RS-tDCS session (that is, the tenth RS-tDCS session)	Acceptability based on subject's readiness, self-confidence, and satisfaction will be considered if at least 60% of all subject's rate "strongly agree" or "agree" on the acceptability questionnaire item 11: "Overall, I felt that transcranial electrical stimulation treatment benefited me" (the questionnaire is a 5-item Likert scale with the following response options "Strongly agree", "Agree", "Neither agree nor disagree", "Disagree", "Strongly disagree").
Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS	day 60 [+ 10 days] from the first RS-tDCS session	Proportion of patients who answered "no" for both questions 1 ("Have you wished you were dead or wished you could go to sleep and not wake up?") and 2 ("Have you actually had any thoughts of killing yourself?") of the C-SSRS
Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale	day 60 [+ 10 days] from the first RS-tDCS session	The 16 items of the CAST Scale assess symptoms across five domains: anxiety (three items, subscore range 3-15), irritability (five items, subscore range 5-25), mania (four items, subscore range 4-20), insomnia (two items, subscore range 2-10), and panic (two items, subscore range 2-10). The total CAST score ranges 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; or 5, strongly agree, with higher scores indicating more severe symptoms.
Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	day 60 [+ 10 days] from the first RS-tDCS session	MADRS is a 10-item questionnaire that includes questions on 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 yields a score of 0 to 6. The overall score ranges from 0 to 60. A higher MADRS score indicates more severe depression.
The Level of Side Effects	The level of side effects will be assessed at the end of each RS-tDCS session	The level of side effects will be assessed at the end of each RS-tDCS session on a 0 (not at all) to 10 (highest degree) scale, which includes the following symptoms: 1. Itching; 2. Burning; 3. Headache; 4. Fatigue; 5. Nervousness; 6. Dizziness; 7. Difficulty concentrating. The total score is the sum of the 7 items, varying from 0 to 70. Higher scores indicate higher levels of side effects.
Treatment Emergent Event	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	After each RS-tDCS session and clinical assessment, subjects will be asked "Have you had any new symptoms, new medical conditions or been started on new medication/treatment since we last saw you?". This information will help research staff to judge about potential adverse events related to the trial. In addition, changes in treatment will help researchers to account for them in data analysis and the study's results interpretation.