Transcranial alternating current stimulation for generalized anxiety disorder and chronic insomnia

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Sao Paulo (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07429578 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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).

Where this trial is running

São Paulo, São Paulo

• University of São Paulo — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Andre R Brunoni, Professor

Conditions Generalized Anxiety Disorder; Chronic Insomnia; tACS; Neuromodulation; Non-invasive brain stimulation; Sleep disorders; Anxiety treatment; Transcranial alternating current stimulation