Home-administered tDCS for Treatment of Depression

An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar Depression

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.

Study Overview

• Status: Completed
• Conditions: Treatment Resistant Depression; Unipolar Depression
• Intervention / Treatment: Device: Soterix Medical mini-CT tDCS stimulator

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10011
      • New York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview.
• Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
• Scored at least 20 on the MADRS at trial entry
• Patient's antidepressant medication is stable for at least 30 days prior to MADRS screening
• Female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential

Exclusion Criteria:

• DSM-V-TR psychotic disorder
• Drug or alcohol abuse or dependence in the preceding 3 months
• Concurrent benzodiazepine medication
• High suicide risk
• History of clinically defined neurological disorder or insult
• Metal in the cranium or skull defects
• Subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator
• Skin lesions on scalp at the proposed electrode sites
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS; Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator	Device: Soterix Medical mini-CT tDCS stimulator; 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.; Other Names: Soterix Medical ElectraRx; Soterix Medical SNAPpad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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)	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.	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.	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).	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.")	Weeks 1-10

Collaborators and Investigators

• Sponsor: Soterix Medical
• Collaborators: NYU Langone Health
• Investigators: Principal Investigator: Abhishek Datta, PhD, Soterix Medical Inc.

Publications and helpful links

General Publications

• Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: tDCS
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
• Other Study ID Numbers: SMI-F10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes