NCT07429578 Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study
| NCT ID | NCT07429578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Generalized Anxiety Disorder (GAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-01 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Age between 18 and 65 years; * Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; * Diagnosis of chronic primary insomnia; * Minimum score of 17 on the Hamilton Anxiety Rating Scale (HAM-A), indicating at least mild to moderate anxiety symptoms; * Score \>7 on the Pittsburgh Sleep Quality Index (PSQI); * Stable use of antidepressants (SSRI or SNRI) is allowed; * Limited use of benzodiazepines (maximum of 10 mg/day diazepam equivalent). Exclusion Criteria: * History of mania, hypomania, or bipolar disorder; * Contraindications to the use of transcranial stimulation; * Active suicidal ideation or suicide attempt in the last 4 weeks; * Refractoriness to 3 or more antidepressant treatments; * Pregnancy; * Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); * Severe medical or neurological conditions; * Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).
Contact & Investigator
Valquíria A Silva, MD, PhD
STUDY CHAIR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT07429578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Generalized Anxiety Disorder (GAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07429578 currently recruiting?
Yes, NCT07429578 is actively recruiting participants. Contact the research team at andre.brunoni@hc.fm.usp.br for enrollment information.
Where is the NCT07429578 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07429578 clinical trial?
NCT07429578 is sponsored by University of Sao Paulo. The principal investigator is Valquíria A Silva, MD, PhD at University of Sao Paulo. The trial plans to enroll 30 participants.
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