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Device

Closed-Loop tACS for Depression (CLACS Trial)

N/A
Waitlist Available
Led By David R Rubinow, MD
Research Sponsored by Electromedical Products International, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 89 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment called closed-loop tACS, which uses gentle electrical currents on the brain to help people with major depressive disorder. The goal is to see if this method can improve mood in those who have not responded well to other treatments.

Who is the study for?
This trial is for adults aged 18-70 with major depressive disorder (MDD), as defined by the DSM-5, who are experiencing symptoms of depression. Participants must have a low suicide risk and not have had recent changes to antidepressant medications or a history of bipolar, psychotic disorders, schizophrenia, autism, severe alcohol or substance use within the last year.
What is being tested?
The study is testing closed-loop transcranial alternating current stimulation (tACS) on individuals with MDD to see if it can alleviate symptoms of depression. The treatment involves using electrical currents applied to the scalp in a controlled manner.
What are the potential side effects?
While specific side effects are not listed here, tACS may potentially cause discomfort at the site of application, headaches, dizziness or other mild side effects typically associated with non-invasive brain stimulation techniques.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~89 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 89 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Altman Self-Rating Mania Scale (ASRM)
Change in Clinical Global Impression Scale (CGI)
Change in Depression Anxiety and Stress Scale (DASS-42)
+4 more
Other study objectives
Change in Alpha Oscillation Power
Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks
Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Closed-loop tACSExperimental Treatment1 Intervention
Closed-loop individual alpha tACS daily for five consecutive days.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER
1,553 Previous Clinical Trials
4,292,960 Total Patients Enrolled
27 Trials studying Schizophrenia
2,655 Patients Enrolled for Schizophrenia
Electromedical Products International, Inc.Lead Sponsor
5 Previous Clinical Trials
527 Total Patients Enrolled
David R Rubinow, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Closed-loop tACS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05772702 — N/A
Schizophrenia Research Study Groups: Closed-loop tACS
Schizophrenia Clinical Trial 2023: Closed-loop tACS Highlights & Side Effects. Trial Name: NCT05772702 — N/A
Closed-loop tACS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05772702 — N/A
~10 spots leftby Nov 2025
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