Home-based tDCS for Prevention of Suicidal Ideation

Study Overview
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Brief Summary
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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).

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

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Device: Home-based transcranial direct current stimulation (tDCS)
* Device: Sham home-based transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active home-based transcranial direct current stimulation (tDCS)<br>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. | Device: Home-based transcranial direct current stimulation (tDCS)<br>* 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.<br>* Other names: Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) device;|
| Sham Comparator: Sham home-based transcranial direct current stimulation (tDCS)<br>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. | Device: Sham home-based transcranial direct current stimulation (tDCS)<br>* 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.<br>* Other names: Soterix 1X1 mini-CT Transcranial Direct Current Stimulation (tcDCS) device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | 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. | 14 days after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | 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. | day 14 [+ 7 days] from the first RS-tDCS session | 
| Intensity of suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | 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. | day 30 [+ 7 days] from the first RS-tDCS session | 
| Intensity of suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | 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. | day 60 [+ 10 days] from the first RS-tDCS session | 
| Acceptability of the intervention | 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). | This information will be collected after the final RS-tDCS session (that is, the tenth RS-tDCS session) | 
| Proportion of patients with no suicidal ideation as assessed by the C-SSRS | 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 | 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 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 | 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 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 | day 60 [+ 10 days] from the first RS-tDCS session | 
| Intensity of rumination as assessed by the Ruminative Responses Scale (RRS) | 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. | day 14 [+ 7 days] from the first RS-tDCS session | 
| Intensity of rumination as assessed by the Ruminative Responses Scale (RRS) | 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. | day 30 [+ 7 days] from the first RS-tDCS session | 
| Intensity of rumination as assessed by the Ruminative Responses Scale (RRS) | 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. | day 60 [+ 10 days] from the first RS-tDCS session | 
| Symptoms associated with suicidal ideation as assessed by the Concise Associated Symptoms Tracking (CAST) scale | 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. | day 14 [+ 7 days] from the first RS-tDCS session | 
| Symptoms associated with suicidal ideation as assessed by the Concise Associated Symptoms Tracking (CAST) scale | 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. | day 30 [+ 7 days] from the first RS-tDCS session | 
| Symptoms associated with suicidal ideation as assessed by the Concise Associated Symptoms Tracking (CAST) scale | 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. | day 60 [+ 10 days] from the first RS-tDCS session | 
| Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | day 14 [+ 7 days] from the first RS-tDCS session | 
| Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | day 30 [+ 7 days] from the first RS-tDCS session | 
| Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) | 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. | day 60 [+ 10 days] from the first RS-tDCS session | 
| The level of side effects | 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. | The level of side effects will be assessed at the end of each RS-tDCS session | 
| Treatment emergent event | 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. | 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 |