Generalized Anxiety Disorder (GAD)NewWavesNCT07429578
Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study
A study testing Transcranial Alternating Current Stimulation (tACS) in people with Generalized Anxiety Disorder (GAD) and Chronic Insomnia, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD), Chronic Insomnia
- What is being tested?
- Transcranial Alternating Current Stimulation (tACS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, São Paulo, 05403-010
Valquíria Aparecida da Silva, Doctor, 11973181756, valquiria.ase@gmail.com
Kallene Vidal, Doctor, kallenesummer@gmail.com
About this study
Official title: Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical 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.
Read the detailed description
Generalized Anxiety Disorder (GAD) and chronic primary insomnia are highly prevalent and frequently co-occurring psychiatric conditions associated with significant functional impairment and reduced quality of life. Both disorders are characterized by dysregulation of cortical and subcortical neural circuits involved in emotional regulation and sleep-wake control, including abnormal oscillatory activity in fronto-limbic networks. Although pharmacological and psychotherapeutic interventions are considered first-line treatments, a substantial proportion of patients remain symptomatic or experience adverse effects, highlighting the need for novel neuromodulatory strategies.
Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that delivers low-intensity sinusoidal electrical currents at specific frequencies to entrain endogenous neural oscillations. By modulating frequency-specific cortical rhythms, tACS may influence neural synchrony and connectivity patterns implicated in anxiety and sleep disturbances.
The present study is an open-label, single-arm pilot clinical trial designed to investigate the feasibility, safety, tolerability, and preliminary clinical effects of tACS in adults with GAD and chronic insomnia. Participants will undergo 20 stimulation sessions administered over four consecutive weeks (five sessions per week). Stimulation will be delivered using the Nexalin device at a frequency of 77.5 Hz and an intensity of 15 mA. Electrodes will be positioned over the frontal pole (Fpz) and bilateral mastoid regions according to the international 10-20 EEG system.
Clinical assessments will be conducted at baseline, at the end of the 4-week treatment phase, and at a 4-week post-treatment follow-up visit. The study will examine changes in anxiety severity, sleep quality, mood symptoms, global clinical status, and cognitive/functional performance to characterize the potential therapeutic effects of this intervention.
The trial will be conducted at the Interdisciplinary Neuromodulation Service of the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo Medical School (IPq-HCFMUSP). Findings from this pilot study are intended to inform the design of future randomized, sham-controlled clinical trials and contribute to the expanding investigation of transcranial alternating current stimulation as a potential treatment modality in anxiety and sleep disorders.
- Being tested
- Transcranial Alternating Current Stimulation (tACS)
- Keywords
- tACS, Neuromodulation, Non-invasive brain stimulation, Sleep disorders, Anxiety treatment, Transcranial alternating current stimulation, Generalized Anxiety Disorder
- Medical subject headings
- Generalized Anxiety Disorder, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial Alternating Current Stimulation (tACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 4, Week 8
Secondary outcomes (4)
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.
Measured: Baseline, Week 4, Week 8
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.
Measured: Baseline, Week 4, Week 8
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.
Measured: Baseline, Week 4, Week 8
Incidence of Treatment-Emergent Adverse Events
Number and nature of adverse events, including local discomfort, headache, skin irritation, or fatigue.
Measured: Throughout the 8-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jun 2025
- Primary completion31 Jan 2026
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label pilot trial with a single arm receiving 20 sessions of transcranial alternating current stimulation (tACS) over four weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre R Brunoni, University of Sao Paulo
- Investigators
- Valquíria A Silva, MD, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429578
- Sponsor's protocol ID
- 85503824.0.0000.0068
- Other IDs
- ID Number: 85503824.0.0000.006
- Acronym
- NewWaves
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this article will be made available after deidentification, including study protocol and statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07429578
- Acronym / sponsor ID
- NewWaves / 85503824.0.0000.0068
- Keywords
- tACS, Neuromodulation, Non-invasive brain stimulation, Sleep disorders, Anxiety treatment, Transcranial alternating current stimulation, Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Generalized Anxiety Disorder (GAD) and chronic primary insomnia are highly prevalent and frequently co-occurring psychiatric conditions associated with significant functional impairment and reduced quality of life. Both disorders are characterized by dysregulation of cortical and subcortical neural circuits involved in emotional regulation and sleep-wake control, including abnormal oscillatory activity in fronto-limbic networks. Although pharmacological and psychotherapeutic interventions are considered first-line treatments, a substantial proportion of patients remain symptomatic or experience adverse effects, highlighting the need for novel neuromodulatory strategies.
Transcranial alternating current stimulation (tACS) is a non-invasive brain stimulation technique that delivers low-intensity sinusoidal electrical currents at specific frequencies to entrain endogenous neural oscillations. By modulating frequency-specific cortical rhythms, tACS may influence neural synchrony and connectivity patterns implicated in anxiety and sleep disturbances.
The present study is an open-label, single-arm pilot clinical trial designed to investigate the feasibility, safety, tolerability, and preliminary clinical effects of tACS in adults with GAD and chronic insomnia. Participants will undergo 20 stimulation sessions administered over four consecutive weeks (five sessions per week). Stimulation will be delivered using the Nexalin device at a frequency of 77.5 Hz and an intensity of 15 mA. Electrodes will be positioned over the frontal pole (Fpz) and bilateral mastoid regions according to the international 10-20 EEG system.
Clinical assessments will be conducted at baseline, at the end of the 4-week treatment phase, and at a 4-week post-treatment follow-up visit. The study will examine changes in anxiety severity, sleep quality, mood symptoms, global clinical status, and cognitive/functional performance to characterize the potential therapeutic effects of this intervention.
The trial will be conducted at the Interdisciplinary Neuromodulation Service of the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo Medical School (IPq-HCFMUSP). Findings from this pilot study are intended to inform the design of future randomized, sham-controlled clinical trials and contribute to the expanding investigation of transcranial alternating current stimulation as a potential treatment modality in anxiety and sleep disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label pilot trial with a single arm receiving 20 sessions of transcranial alternating current stimulation (tACS) over four weeks.
| Arm | Type | Receives |
|---|---|---|
| tACS Group | Experimental | Device: Transcranial Alternating Current Stimulation (tACS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Alternating Current Stimulation (tACS)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. | Device | tACS Group |
Primary outcome
Change in Anxiety Severity Measured by the Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline, Week 4, Week 8
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.
Change in Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Time frame: Baseline, Week 4, Week 8
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.
4 secondary outcomes
Change in Depressive Symptoms Measured by the Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline, Week 4, Week 8
Change in Global Clinical Status Measured by the Clinical Global Impression (CGI) Scale
Time frame: Baseline, Week 4, Week 8
Change in Quality of Life Measured by the WHOQOL-BREF
Time frame: Baseline, Week 4, Week 8
Incidence of Treatment-Emergent Adverse Events
Time frame: Throughout the 8-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this article will be made available after deidentification, including study protocol and statistical analysis plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valquíria A Silva, MD, PhD study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation (tACS) in people with Generalized Anxiety Disorder (GAD) and Chronic Insomnia, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre R Brunoni, Professor (+55 (11) 2661-8159, andre.brunoni@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Severity Measured by the Hamilton Anxiety Rating Scale (HAM-A) (time frame: Baseline, Week 4, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.