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Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS)

Primary Purpose

Depression, Major Depressive Disorder, tACS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Closed-loop tACS
Sponsored by
Electromedical Products International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carolina Center for NeurostimulationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Closed-loop tACS

Arm Description

Closed-loop individual alpha tACS daily for five consecutive days.

Outcomes

Primary Outcome Measures

HDRS-17 change
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

HDRS-17 change
Change in HDRS-17 between one week follow-up (FU1) and D1
HDRS-17 change
Change in HDRS-17 between D5 and D1
Response/Remission of depression
Number of response/remission rates at D5, FU1 and FU2
Change in Quick Inventory of Depressive Symptomatology (QIDS)
Change in QIDS at D5, FU1, FU2; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.
Change in Altman Self-Rating Mania Scale (ASRM)
Change in ASRM at D5, FU1, FU2; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Change in SHAPS at D5, FU1, FU2; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.
Change in Depression Anxiety and Stress Scale (DASS-42)
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.
Change in State-Train Anxiety Inventory (STAI)
Change in STAI at D5, FU1, FU2; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Change in Q-LES-Q-SF at D5, FU1, FU2; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Change in Clinical Global Impression Scale (CGI)
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.

Full Information

First Posted
February 24, 2023
Last Updated
March 6, 2023
Sponsor
Electromedical Products International, Inc.
Collaborators
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05772702
Brief Title
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression
Acronym
CLACS
Official Title
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Electromedical Products International, Inc.
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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 20 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) using the Hamilton Depression Rating Scale (HDRS-17).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder, tACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-Label
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closed-loop tACS
Arm Type
Experimental
Arm Description
Closed-loop individual alpha tACS daily for five consecutive days.
Intervention Type
Device
Intervention Name(s)
Closed-loop tACS
Intervention Description
Individual alpha tACS
Primary Outcome Measure Information:
Title
HDRS-17 change
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
HDRS-17 change
Description
Change in HDRS-17 between one week follow-up (FU1) and D1
Time Frame
14 days
Title
HDRS-17 change
Description
Change in HDRS-17 between D5 and D1
Time Frame
5 days
Title
Response/Remission of depression
Description
Number of response/remission rates at D5, FU1 and FU2
Time Frame
21 days
Title
Change in Quick Inventory of Depressive Symptomatology (QIDS)
Description
Change in QIDS at D5, FU1, FU2; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.
Time Frame
21 days
Title
Change in Altman Self-Rating Mania Scale (ASRM)
Description
Change in ASRM at D5, FU1, FU2; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.
Time Frame
21 days
Title
Change in Snaith-Hamilton Pleasure Scale (SHAPS)
Description
Change in SHAPS at D5, FU1, FU2; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.
Time Frame
21 days
Title
Change in Depression Anxiety and Stress Scale (DASS-42)
Description
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.
Time Frame
21 days
Title
Change in State-Train Anxiety Inventory (STAI)
Description
Change in STAI at D5, FU1, FU2; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.
Time Frame
21 days
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)
Description
Change in Q-LES-Q-SF at D5, FU1, FU2; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.
Time Frame
21 days
Title
Change in Clinical Global Impression Scale (CGI)
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias U Schwippel, MD
Phone
817-609-4460
Email
tobias_schwippel@unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary J Stewart, MSc
Email
zachary_stewart@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Rubinow, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Center for Neurostimulation
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias U Schwippel, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30837453
Citation
Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0.
Results Reference
background
Links:
URL
https://researchforme.unc.edu/index.php/en/study-details?rcid=4419
Description
Link to more information and study recruitment for interested potential participants.

Learn more about this trial

Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression

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