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Home-administered tDCS for Treatment of Depression

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ClinicalTrials.gov Identifier: NCT04781127
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
NYU Langone Health
Information provided by (Responsible Party):
Soterix Medical

Tracking Information
First Submitted Date  ICMJE February 25, 2021
First Posted Date  ICMJE March 4, 2021
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE February 10, 2021
Estimated Primary Completion Date August 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
Change in Mood [ 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) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
  • Self-Reported Mood Score [ Time Frame: Weeks 1-10. Patients who receive maintenance sessions will also report before sessions 33-46 (Weeks 11-30) ]
    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.
  • Quick Inventory of Depressive Symptomology (QIDS-SR) [ 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 ]
    Patients will enter responses at the end of each week on the web interface. (16 question survey with higher score for more severe symptoms)
  • Quality of Life Enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF) [ 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 ]
    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)
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ 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) ]
    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.
  • Self-report Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Weeks 1-10 ]
    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.
  • Adverse Effects: Pain [ Time Frame: Weeks 1-10 ]
    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).
  • Adverse Effects: Suicidal Ideation [ Time Frame: Weeks 1-10 ]
    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.")
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2021)
  • Self-Reported Mood Score [ Time Frame: Weeks 1-10. Patients who receive maintenance sessions will also report before sessions 33-46 (Weeks 11-30) ]
    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.
  • Quick Inventory of Depressive Symptomology (QIDS-SR) [ 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 ]
    Patients will enter responses at the end of each week on the web interface. (16 question survey with higher score for more severe symptoms)
  • Quality of Life Enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF) [ 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 ]
    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)
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ 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) ]
    Patients will respond to questions about suicidal ideation and behavior, whereby more "yes" answers indicates worse outcomes.
  • Self-report Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Weeks 1-10 ]
    Patients will enter scores before each treatment session on the web interface.
  • Adverse Effects: Pain [ Time Frame: Weeks 1-10 ]
    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). suicidal ideation rated 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."
  • Adverse Effects: Suicidal Ideation [ Time Frame: Weeks 1-10 ]
    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.")
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home-administered tDCS for Treatment of Depression
Official Title  ICMJE An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar Depression
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Unipolar Depression
  • Treatment Resistant Depression
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Active tDCS
Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator
Intervention: Device: Soterix Medical mini-CT tDCS stimulator
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, Benseñor 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 10, 2022
Estimated Primary Completion Date August 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04781127
Other Study ID Numbers  ICMJE SMI-F10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Soterix Medical
Study Sponsor  ICMJE Soterix Medical
Collaborators  ICMJE NYU Langone Health
Investigators  ICMJE
Principal Investigator: Abhishek Datta, PhD Soterix Medical Inc.
PRS Account Soterix Medical
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP