NCT05772702

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Electromedical Products International, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Major Depressive Disorder
• tACS

Interventions

Type	Name	Description
DEVICE	Closed-loop tACS	Individual alpha tACS

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-04-22
• Completion: 2024-08-19
• First posted: 2023-03-16
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study