Home-based Transcranial Direct-current Stimulation (tDCS) for Prevention of Suicidal Ideation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active 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.
干预措施: Home-based transcranial direct current stimulation (tDCS) (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.
干预措施: Sham home-based transcranial direct current stimulation (tDCS) (Device)
结局指标
主要结局
Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions
时间窗: 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.
次要结局
- Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS(day 60 [+ 10 days] from the first RS-tDCS session)
- Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 14(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(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(Day 60 (± 10 days) from the first RS-tDCS session)
- Acceptability of the Intervention as Assessed by Participant-reported Questionnaire(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)(day 14 [+ 7 days] from the first RS-tDCS session)
- Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS(day 30 [+ 7 days] from the first RS-tDCS session)
- Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 14(day 14 [+ 7 days] from the first RS-tDCS session)
- Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 30(day 30 [+ 7 days] from the first RS-tDCS session)
- Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 60(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(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(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(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(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(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(day 60 [+ 10 days] from the first RS-tDCS session)
- Mean Cumulative Side Effect Score Per Participant Across RS tDCS Sessions(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(Assessed after each RS tDCS session during the 4 week treatment period)
研究者
Yeates Conwell, MD
Professor
University of Rochester