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

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

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).

Conditions3

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