Actively Recruiting
Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study
Led by University of Sao Paulo · Updated on 2026-02-24
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.
CONDITIONS
Official Title
Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of Generalized Anxiety Disorder based on DSM criteria
- Diagnosis of chronic primary insomnia
- Minimum score of 17 on the Hamilton Anxiety Rating Scale indicating mild to moderate anxiety
- Score greater than 7 on the Pittsburgh Sleep Quality Index
- Stable use of antidepressants (SSRI or SNRI) allowed
- Limited use of benzodiazepines, maximum 10 mg/day diazepam equivalent
You will not qualify if you...
- History of mania, hypomania, or bipolar disorder
- Contraindications to transcranial stimulation
- Active suicidal thoughts or suicide attempt in the last 4 weeks
- Resistance to 3 or more antidepressant treatments
- Pregnancy
- Other psychiatric diagnoses such as schizophrenia, substance dependence, or major depressive disorder
- Severe medical or neurological conditions
- Anxiety or insomnia caused by other medical or psychiatric conditions like hypothyroidism or anemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of São Paulo
São Paulo, São Paulo, Brazil, 05403-010
Actively Recruiting
Research Team
A
Andre R Brunoni, Professor
CONTACT
K
Kallene S Vidal, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here