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

NCT07429578 | Recruiting

• 2 other identifiers: 85503824.0.0000.0068ID Number: 85503824.0.0000.006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder (GAD); Chronic Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Anxiety Severity Measured by the Hamilton Anxiety Rating Scale (HAM-A)

  The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale ranging from 0 to 56, with higher scores indicating greater anxiety severity. The outcome measure is the change in total HAM-A score from baseline to Week 4 and Week 8.

  Baseline, Week 4, Week 8

• Change in Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire ranging from 0 to 21, with higher scores indicating worse sleep quality. The outcome measure is the change in total PSQI score from baseline to Week 4 and Week 8.

  Baseline, Week 4, Week 8

Secondary Outcomes (4)

• Change in Depressive Symptoms Measured by the Hamilton Depression Rating Scale (HAM-D)

  Baseline, Week 4, Week 8

• Change in Global Clinical Status Measured by the Clinical Global Impression (CGI) Scale

  Baseline, Week 4, Week 8

• Change in Quality of Life Measured by the WHOQOL-BREF

  Baseline, Week 4, Week 8

• Incidence of Treatment-Emergent Adverse Events

  Throughout the 8-week study period

Study Arms (1)

tACS Group

EXPERIMENTAL

Participants will receive 20 sessions of transcranial alternating current stimulation (tACS) over four weeks (five sessions per week). The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device, with electrodes placed at Fpz and mastoid areas.

Device: Transcranial Alternating Current Stimulation (tACS)

Interventions

Transcranial Alternating Current Stimulation (tACS) DEVICE

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.

tACS Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Valquíria A Silva, MD, PhD

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Andre R Brunoni, Professor

CONTACT

+55 (11) 2661-8159; andre.brunoni@hc.fm.usp.br

Kallene S Vidal, Professor

CONTACT

+55 (11) 2661-8159; kallenesummer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open-label pilot trial with a single arm receiving 20 sessions of transcranial alternating current stimulation (tACS) over four weeks.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: February 24, 2026
• Study Start: June 1, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months following publication, for up to 2 years.
• Access Criteria: Qualified researchers whose proposals are approved by the principal investigator will be granted access to deidentified individual participant data. Requests must include a clear scientific rationale and plan for data use. Data will be shared through secure electronic transfer upon agreement with data use terms.

Locations

BR (1)