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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

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.

Condition or disease Intervention/treatment Phase
Unipolar Depression Treatment Resistant Depression Device: Soterix Medical mini-CT tDCS stimulator Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Home-administered Transcranial Direct Current Stimulation (tDCS) Clinical Trial of Unipolar Depression
Actual Study Start Date : February 10, 2021
Estimated Primary Completion Date : August 10, 2022
Estimated Study Completion Date : August 10, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)

  4. 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.

  5. 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.

  6. 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).

  7. 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.")



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781127


Locations
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United States, New York
New York University Recruiting
New York, New York, United States, 10011
Contact: Matthew Lustberg, MA    929-445-5090    Matthew.Lustberg@nyulangone.org   
Sponsors and Collaborators
Soterix Medical
NYU Langone Health
Investigators
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Principal Investigator: Abhishek Datta, PhD Soterix Medical Inc.
Publications:
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Responsible Party: Soterix Medical
ClinicalTrials.gov Identifier: NCT04781127    
Other Study ID Numbers: SMI-F10
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Soterix Medical:
tDCS
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders