RecruitingNot ApplicableNCT07429578

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial


Sponsor

University of Sao Paulo

Enrollment

30 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a non-invasive brain stimulation technique called transcranial alternating current stimulation (tACS) for people who have both generalised anxiety disorder (persistent, hard-to-control worry) and chronic insomnia. The device delivers gentle electrical currents to the scalp to try to improve both sleep and anxiety. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with generalised anxiety disorder (GAD) - You also have chronic primary insomnia - Your anxiety and sleep scores are above clinical thresholds on standardised scales - If you take antidepressants (SSRIs or SNRIs), your dose has been stable **You may NOT be eligible if...** - You have a history of bipolar disorder or mania - You have contraindications to brain stimulation therapy - You have had active suicidal thoughts or a suicide attempt in the last 4 weeks - Your anxiety has not responded to 3 or more prior antidepressant treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscranial Alternating Current Stimulation (tACS)

20 sessions of 40 minutes each, applied five times per week over four weeks, with a current of 15 mA at 77.5 Hz using the Nexalin device.


Locations(1)

University of São Paulo

São Paulo, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07429578


Related Trials