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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 89 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~89 days
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 moreOther 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 moreAwards & 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
1,561 Previous Clinical Trials
4,298,715 Total Patients Enrolled
60 Trials studying Depression
35,338 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.I am currently taking more than 20mg of diazepam or its equivalent daily.My antidepressant dose has not changed in the last 2 weeks.I started a new antidepressant less than 4 weeks ago.I understand all the risks and benefits of joining this study.
Research Study Groups:
This trial has the following groups:- Group 1: Closed-loop tACS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.