This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks.
The Soterix Medical 1X1 mini-CT will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tDCS) in treating unipolar depression. Specifically efficacy will be determined by change in MADRS score from baseline to the 10 week follow-up. Feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed. Self-reported mood scores will be evaluated using the Quick Inventory of Depressive Symptomatology (QIDS-SR) and Quality of Life enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF). All visits will be performed via telephone or video conference. Subjects will be taught to operate the tDCS system and complete a tolerability check. The treatment course will consist of an acute phase of 28 tDCS sessions conducted Monday - Friday over 6 weeks. This is followed by a taper of 4 tDCS sessions spaced 1 week apart. Patients who meet criteria for clinical response (\>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months. Mood assessments will be conducted at baseline, 2 weeks, 4 weeks and 6 weeks in the acute treatment phase. In the taper phase, assessments wil be conducted at 1 month (end of taper), 3 and 6 months following completion of the acute phase. All assessments in the acute treatment phase and the taper phase will have a +/- 1 week collection window.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Stimulation will last 30 minutes per day, 5 days per week, for 5 weeks, then 3 days per week for 1 week and then 1 day per week for 4 weeks.
New York University
New York, New York, United States
Change in Mood
Mood will be assessed with the Montgomery Asberg Depression Rating Scale (MADRS). Patients who meet criteria for clinical response (\>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months.
Time frame: Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)
Self-Reported Mood Score
Patients will enter daily mood scores before each treatment session on a scale of 0-10 (0= feeling normal and not depressed at all and 10= feeling as depressed as possible) on the web interface.
Time frame: Weeks 1-10. Patients who receive maintenance sessions will also report before sessions 33-46 (Weeks 11-30)
Quick Inventory of Depressive Symptomology (QIDS-SR)
Patients will enter responses at the end of each week on the web interface. (16 question survey with higher score for more severe symptoms)
Time frame: Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30
Quality of Life Enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF)
Patients will enter responses at the end of each week on the web interface. (16 question survey with answers between 1-5 where higher score represents better outcomes)
Time frame: Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30
Columbia Suicide Severity Rating Scale (C-SSRS)
Patients will respond to questions about suicidal ideation and behavior, where "yes" or "no" answers indicate level of risk (low, moderate or high). More "yes" answers indicate worse outcomes.
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Time frame: Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)
Self-report Columbia Suicide Severity Rating Scale (C-SSRS)
Patients will enter scores before each treatment session on the web interface about suicidal ideation and behavior, where "yes" or "no" answers indicate level of risk (low, moderate or high). More "yes" answers indicate worse outcomes.
Time frame: Weeks 1-10
Adverse Effects: Pain
Participants will enter any side effects experienced, their severity (mild, moderate, severe), pain scores based on the Wong-Baker pain scale and temporal relationship with the tDCS session (before, during, after).
Time frame: Weeks 1-10
Adverse Effects: Suicidal Ideation
Participants will enter a score using item 9 of the Beck Depression Inventory (range from 0 = "I don't have any thoughts of killing myself." to 3 = "I would kill myself if I had the chance.")
Time frame: Weeks 1-10