Transcranial alternating current stimulation for generalized anxiety disorder and chronic insomnia
Official title: Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial
Run by University of Sao Paulo · NCT07429578 · Data updated 2026-11-12
This study will try 20 sessions of transcranial alternating current stimulation (tACS) with the Nexalin device to see if it improves anxiety and sleep in adults with generalized anxiety disorder and chronic insomnia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | January 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07429578 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with DSM-diagnosed generalized anxiety disorder and chronic primary insomnia who have HAM-A scores ≥17 and PSQI >7, including those on stable SSRIs/SNRIs and limited benzodiazepine use, are the intended participants.
✕Probably not a fit
Patients with bipolar disorder, psychotic disorders, substance dependence, recent suicidal ideation, pregnancy, severe medical or neurological illness, or anxiety/insomnia secondary to other conditions are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, single-arm pilot enrolls 30 adults with DSM-diagnosed generalized anxiety disorder and chronic primary insomnia to receive 20 tACS sessions over four weeks (five sessions per week). Stimulation is delivered with the Nexalin device at 77.5 Hz and 15 mA with the goal of modulating neural oscillations implicated in anxiety and sleep regulation. Primary aims are to examine feasibility, safety, tolerability, and preliminary changes in anxiety and sleep quality. Results are intended to generate early efficacy signals to inform future randomized controlled trials.
Why it matters
Potential benefit: If successful, the treatment could reduce anxiety symptoms and improve sleep quality without adding systemic medication side effects.
How similar studies have gone: tACS is an emerging, largely experimental neuromodulation approach with a few small studies suggesting effects on neural rhythms and sleep/anxiety symptoms, but randomized, well-controlled evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion 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; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score \>5 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).
Where it's running
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University of São Paulo
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Andre R Brunoni, Professor
- Email: andre.brunoni@hc.fm.usp.br
- Phone: +55 (11) 2661-8159
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.