CES for Generalized Anxiety Disorder
Trial Summary
Do I have to stop taking my current medications for the trial?
You don't have to stop taking your current medications, but you need to keep the dose stable for 2 weeks before the screening visit, or 4 weeks if you're on antidepressants. You can also participate if you're not taking any medications.
What data supports the effectiveness of the treatment At-Home Stimulation, Transcranial Direct Current Stimulation (tDCS), Cranial Electrotherapy Stimulation (CES), At-Home Brain Stimulation for Generalized Anxiety Disorder?
Research shows that both transcranial direct current stimulation (tDCS) and cranial electrotherapy stimulation (CES) can help reduce anxiety symptoms. Studies have found that tDCS, especially when combined with therapy, and CES are effective in treating anxiety and depression, with improvements seen in patients with generalized anxiety disorder.12345
Is cranial electrotherapy stimulation (CES) safe for humans?
Cranial electrotherapy stimulation (CES) and similar techniques like transcranial direct current stimulation (tDCS) are generally considered safe for humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches, fatigue, and skin sensations are possible, but serious issues are rare.23678
How does At-Home Stimulation differ from other treatments for generalized anxiety disorder?
At-Home Stimulation, which includes techniques like transcranial direct current stimulation (tDCS) and cranial electrotherapy stimulation (CES), is unique because it is a non-invasive brain stimulation method that can be administered at home, offering convenience and potentially fewer side effects compared to traditional medication. It uses gentle electrical currents to influence brain activity, which is different from medications that alter brain chemistry.23459
What is the purpose of this trial?
The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.
Research Team
Samantha Meltzer-Brody, MD, MPH
Principal Investigator
University of North Carolina, Chapel Hill
Eligibility Criteria
This trial is for young adults aged 18-21 with Generalized Anxiety Disorder (GAD). Participants must be able to consent, follow the study's procedures, and use effective contraception if applicable. They should have mild-to-moderate anxiety symptoms and either maintain a stable dose of current psychiatric meds or not change their treatment during the study.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including clinical assessments of anxiety symptoms and resting-state EEG collection
Treatment
Participants receive either active or sham CES daily for six weeks
Follow-up 1
Clinical assessments of anxiety symptoms and resting-state EEG collection
Follow-up 2
Final clinical assessments of anxiety symptoms and other secondary outcomes
Treatment Details
Interventions
- At-Home Stimulation
At-Home Stimulation is already approved in European Union, United States for the following indications:
- Depression
- Experimental for depression, chronic pain, and PTSD
Find a Clinic Near You
Who Is Running the Clinical Trial?
Electromedical Products International, Inc.
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborator