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

Electromedical Products International

Status

Active, not recruiting

Conditions

tACS

Major Depressive Disorder

Depression

Treatments

Device: Closed-loop tACS

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05772702

22-3094

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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