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

ConditionsGeneralized Anxiety Disorder (GAD)Chronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Sao Paulo

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: tACS GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Week 4, Week 8
2

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.

Time frame
Baseline, Week 4, Week 8

Secondary outcomes

1

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

The Hamilton Depression Rating Scale (HAM-D) ranges from 0 to 52, with higher scores indicating greater depressive symptom severity. The outcome measure is the change in total HAM-D score from baseline to Week 4 and Week 8.

Time frame
Baseline, Week 4, Week 8
2

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

The Clinical Global Impression (CGI) scale includes severity and improvement subscales. The CGI-Severity scale ranges from 1 to 7, with higher scores indicating greater illness severity. The outcome measure includes changes from baseline to Week 4 and Week 8.

Time frame
Baseline, Week 4, Week 8
3

Change in Quality of Life Measured by the WHOQOL-BREF

The World Health Organization Quality of Life - Brief Version (WHOQOL-BREF) is a self-reported questionnaire assessing quality of life across physical, psychological, social, and environmental domains. Scores range from 0 to 100, with higher scores indicating better quality of life. The outcome measure is the change in total score from baseline to Week 4 and Week 8.

Time frame
Baseline, Week 4, Week 8
4

Incidence of Treatment-Emergent Adverse Events

Number and nature of adverse events, including local discomfort, headache, skin irritation, or fatigue.

Time frame
Throughout the 8-week study period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Source ClinicalTrials.gov
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