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Trial record 1 of 1 for:    NCT05772702
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Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS)

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ClinicalTrials.gov Identifier: NCT05772702
Recruitment Status : Recruiting
First Posted : March 16, 2023
Last Update Posted : January 18, 2024
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Electromedical Products International, Inc.

Study Description
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Brief Summary:
The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.

Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder tACS Device: Closed-loop tACS Not Applicable

Detailed Description:

The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit up to 35 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey.

Potential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation, FU2) using the Hamilton Depression Rating Scale (HDRS-17).

For a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2.

For a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-Label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study
Actual Study Start Date : February 13, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : August 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Closed-loop tACS
Closed-loop individual alpha tACS daily for five consecutive days.
 Device: Closed-loop tACS
Individual alpha tACS


Outcome Measures
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Primary Outcome Measures :
  1. HDRS-17 change [ Time Frame: 21 days ]
    Change in HDRS-17 between two week follow-up (FU2) and Day 1 (D1); minimum value is 0, maximum value is 52. Higher scores indicate worse outcome.


Secondary Outcome Measures :
  1. HDRS-17 change [ Time Frame: 14 days ]
    Change in HDRS-17 between one week follow-up (FU1) and D1

  2. HDRS-17 change [ Time Frame: 5 days ]
    Change in HDRS-17 between D5 and D1

  3. Response/Remission of depression [ Time Frame: 21 days ]
    Number of response/remission rates at D5, FU1 and FU2

  4. Change in Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 21 days ]
    Change in QIDS at D5, FU1, FU2; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.

  5. Change in Altman Self-Rating Mania Scale (ASRM) [ Time Frame: 21 days ]
    Change in ASRM at D5, FU1, FU2; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.

  6. Change in Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 21 days ]
    Change in SHAPS at D5, FU1, FU2; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.

  7. Change in Depression Anxiety and Stress Scale (DASS-42) [ Time Frame: 21 days ]
    Change in DASS-42 at D5, FU1, FU2; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.

  8. Change in State-Train Anxiety Inventory (STAI) [ Time Frame: 21 days ]
    Change in STAI at D5, FU1, FU2; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.

  9. Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) [ Time Frame: 21 days ]
    Change in Q-LES-Q-SF at D5, FU1, FU2; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.

  10. Change in Clinical Global Impression Scale (CGI) [ Time Frame: 21 days ]
    Change in CGI at Day 5, FU1 and FU2; CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.


Other Outcome Measures:
  1. Change in Alpha Oscillation Power [ Time Frame: 21 days ]
    Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2.

  2. Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks [ Time Frame: 91 days ]
    Change in QIDS at D5, FU1, FU2, four week follow-up (FU3), six week follow-up (FU4), eight week follow-up (FU5), ten week follow-up (FU6), and twelve week follow-up (FU7); minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.

  3. Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks [ Time Frame: 91 days ]
    Change in ASRM at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.

  4. Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks [ Time Frame: 91 days ]
    Change in SHAPS at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.

  5. Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks [ Time Frame: 91 days ]
    Change in DASS-42 at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.

  6. Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks [ Time Frame: 91 days ]
    Change in STAI at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.

  7. Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) [ Time Frame: 91 days ]
    Change in Q-LES-Q-SF at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-70 years
  • Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic
  • Hamilton Rating Depression Rating Scale (HRDS-17) score >8
  • Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan)
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent)

Exclusion Criteria:

  • DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months.
  • DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.
  • Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism
  • Current use of benzodiazepines > 20mg diazepam/d equivalent
  • Antidepressant dose change within the last 2 weeks
  • Initiated new antidepressant within the last 4 weeks
Contacts and Locations
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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): NCT05772702


Contacts
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Contact: Tobias U Schwippel, MD 817-609-4460 tobias_schwippel@unc.edu
Contact: Zachary J Stewart zachary_stewart@med.unc.edu

Locations
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United States, North Carolina
Carolina Center for Neurostimulation Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Tobias U Schwippel, MD         
Sponsors and Collaborators
Electromedical Products International, Inc.
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: David R Rubinow, MD University of North Carolina, Chapel Hill
More Information
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Additional Information:

Publications:

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Responsible Party: Electromedical Products International, Inc.
ClinicalTrials.gov Identifier: NCT05772702    
Other Study ID Numbers: 22-3094
First Posted: March 16, 2023    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: January 2024
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders