Clinical trial NCT05772702: Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression
Official title: Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Major Depressive Disorder
tACS
Lead sponsor: Electromedical Products International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2023-03-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale 17-item (HDRS-17)
timeFrame: Day 1 to Day 19 (i.e. 19 days)
Secondary outcomes:
measure: Change in Hamilton Depression Rating Scale 17-item (HDRS-17)
timeFrame: Day 1 to Day 5 (i.e., 5 days)
measure: Response/Remission of Depression
timeFrame: Day 5 and Day 19
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
measure: Change in Altman Self-Rating Mania Scale (ASRM)
timeFrame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
measure: Change in Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
measure: Change in Depression Anxiety and Stress Scale (DASS-42)
timeFrame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
measure: Change in State-Train Anxiety Inventory (STAI)
timeFrame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)
timeFrame: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)
measure: Change in Clinical Global Impression Scale (CGI)
timeFrame: Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)}
Other outcomes:
measure: Change in Alpha Oscillation Power
timeFrame: 19 days
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks
timeFrame: 89 days
measure: Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks
timeFrame: 89 days
measure: Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks
timeFrame: 89 days
measure: Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks
timeFrame: 89 days
measure: Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks
timeFrame: 89 days
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)
timeFrame: 89 days
measure: HDRS-17 Change
timeFrame: 47 Days
Locations:
city: Chapel Hill
country: United States
facility: Carolina Center for Neurostimulation
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: David R Rubinow, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.