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Completed

NCT Number: NCT05772702

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders tACS

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed-loop tACS

Device

Individual alpha tACS

Primary outcomes

  1. Change in Hamilton Depression Rating Scale 17-item (HDRS-17)

    Time frame: Day 1 to Day 19 (i.e. 19 days)

    Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.

Secondary outcomes

  1. Change in Hamilton Depression Rating Scale 17-item (HDRS-17)

    Time frame: Day 1 to Day 5 (i.e., 5 days)

    Change in HDRS-17 from Day 1 (D1) to Day 5 (D5); HDRS-17minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.

  2. Response/Remission of Depression

    Time frame: Day 5 and Day 19

    Number of response/remission rates at Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2). Response defined as >=50% reduction in HDRS-17 from D1. Remission defined as HDRS-17 score <=7.

  3. Change in Quick Inventory of Depressive Symptomatology (QIDS)

    Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

    Change in QIDS at Day 5 (D5), Day 12 (i.e., one-week follow-up; FU1), and Day 19 (i.e., two-week follow-up; FU2); QIDS minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

  4. Change in Altman Self-Rating Mania Scale (ASRM)

    Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

    Change in ASRM at Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); ASRM minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

  5. Change in Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

    Change in SHAPS from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); SHAPS minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

  6. Change in Depression Anxiety and Stress Scale (DASS-42)

    Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

    Change in DASS-42 from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); DASS-42 minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. Negative scores indicate improved outcome.

  7. Change in State-Train Anxiety Inventory (STAI)

    Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

    Change in STAI from Day 1 (D1) to Day 5 (D5), Day 12 (one week follow-up; FU1), and Day 19 (two week follow-up; FU2); STAI minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

  8. Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)

    Time frame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

    Change in Q-LES-Q-SF from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); Q-LES-Q-SF minimum value is 14, maximum value is 70. Higher scores indicate better outcome. Negative scores indicate worse outcome.

  9. Change in Clinical Global Impression Scale (CGI)

    Time frame: Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)}

    Change in CGI from Day 1 (D1) to Day 5 (D5) and Day 19 (i.e., two week follow-up; 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 outcomes

  1. Change in Alpha Oscillation Power

    Time frame: 19 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: 89 days

    Change in QIDS at 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: 89 days

    Change in ASRM at 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: 89 days

    Change in SHAPS at 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: 89 days

    Change in DASS-42 at 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: 89 days

    Change in STAI at 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: 89 days

    Change in Q-LES-Q-SF at FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.

  8. HDRS-17 Change

    Time frame: 47 Days

    Change in HDRS-17 between six week follow up (FU4) and D1

Sponsors and collaborators

Lead sponsor

Electromedical Products International, Inc.

Industry

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study

Acronym: CLACS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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