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Device

Closed-Loop tACS for Depression (CLACS Trial)

N/A

Recruiting

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 91 days

Awards & highlights

CLACS Trial Summary

This trial looks at how electrical stimulation of the brain can help reduce symptoms of depression.

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.Check my eligibility

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.See study design

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.

CLACS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 91 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~91 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 91 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Altman Self-Rating Mania Scale (ASRM)

Change in Clinical Global Impression Scale (CGI)

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

+5 more

Other outcome measures

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

+4 more

CLACS Trial Design

1Treatment groups

Experimental Treatment

Group I: Closed-loop tACSExperimental Treatment1 Intervention

Closed-loop individual alpha tACS daily for five consecutive days.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,581 Total Patients Enrolled

54 Trials studying Depression

33,663 Patients Enrolled for Depression

Electromedical Products International, Inc.Lead Sponsor

5 Previous Clinical Trials

527 Total Patients Enrolled

3 Trials studying Depression

236 Patients Enrolled for Depression

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

Depression Research Study Groups: Closed-loop tACS

Depression 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any volunteer participants currently needed for this research?

"Indeed, clinicaltrials.gov lists this medical trial as an active participant recruitment opportunity. The study was first published on February 13th 2023 and last edited on March 6th of the same year. It is currently seeking to enroll a total of twenty participants at one location."

Answered by AI

Do I qualify to involve myself in this experiment?

"To be eligible for this medical research, subjects must suffer from depression and fall within the ages of 18 to 70. The trial requires 20 participants in total."

Answered by AI

What is the aggregate patient count for this exploration?

"Affirmative. Records posted on clinicaltrials.gov verify that this research project, which was first listed on February 13th 2023, is actively searching for volunteers. To date, 1 centre needs to enrol around 20 participants."

Answered by AI