Clinical trial NCT05280756: Home-based tDCS for Prevention of Suicidal Ideation
Official title: Home-based Transcranial Direct-current Stimulation (tDCS) for Prevention of Suicidal Ideation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2022-03-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions
timeFrame: 14 days after start of treatment
Secondary outcomes:
measure: Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: day 14 [+ 7 days] from the first RS-tDCS session
measure: Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: day 30 [+ 7 days] from the first RS-tDCS session
measure: Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: day 60 [+ 10 days] from the first RS-tDCS session
measure: Acceptability of the Intervention
timeFrame: This information will be collected after the final RS-tDCS session (that is, the tenth RS-tDCS session)
measure: Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
timeFrame: day 14 [+ 7 days] from the first RS-tDCS session
measure: Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
timeFrame: day 30 [+ 7 days] from the first RS-tDCS session
measure: Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
timeFrame: day 60 [+ 10 days] from the first RS-tDCS session
measure: Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)
timeFrame: day 14 [+ 7 days] from the first RS-tDCS session
measure: Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)
timeFrame: day 30 [+ 7 days] from the first RS-tDCS session
measure: Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)
timeFrame: day 60 [+ 10 days] from the first RS-tDCS session
measure: Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale
timeFrame: day 14 [+ 7 days] from the first RS-tDCS session
measure: Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale
timeFrame: day 30 [+ 7 days] from the first RS-tDCS session
measure: Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale
timeFrame: day 60 [+ 10 days] from the first RS-tDCS session
measure: Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: day 14 [+ 7 days] from the first RS-tDCS session
measure: Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: day 30 [+ 7 days] from the first RS-tDCS session
measure: Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: day 60 [+ 10 days] from the first RS-tDCS session
measure: The Level of Side Effects
timeFrame: The level of side effects will be assessed at the end of each RS-tDCS session
measure: Treatment Emergent Event
timeFrame: 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
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Yeates Conwell, MD
role: PRINCIPAL_INVESTIGATOR
References: