AnxietyAnsitDCSNCT07116980

Biological and Psychological Markers After Intervention in Adults With GAD

A study testing 'Transcranial Direct Current Stimulation - tDCS in people with Anxiety, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Anxiety
What is being tested?: 'Transcranial Direct Current Stimulation - tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteBrazil
Study dates: 21 Jun 2023to 25 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

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 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Adults under the age of 18;
GAD-7 ≥ 10
Possibility of being present on previously agreed days.

Who cannot join

Being in psychopharmacological treatment for depression;
HAM-D≥23 scale;
have a self-reported severe disorder (psychosis, schizophrenia, substance abuse, major depression);
having had seizures and epilepsy;
having presented substance use disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months;
being pregnant or breastfeeding;
have suffered any type of brain injury or surgery, heart disease or cranial defect.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903

Other trials in Brazil

About this study

Official title: Biological and Psychological Markers After Trancranial Electrical Stimulation in Adults With Generalized Anxiety Disorder

This clinical trial inestigates the effects of transcranial direct current stimulation (tDCS) on anxiety symptoms in adult women with clinically relevant anxiety levels. The intervention involves the application of low-intensity electrical current over the left dorsolateral prefrontal cortex (DLPFC) across twenty consecutive sessions. Participants are randomly assigned to either an active or sham stimulation group in a double-blind design. The study aims to evaluate changes in anxiety symptoms, emotional regulation, and physiological and molecular markers, including EEG activity, heart rate variability (HRV), and salivary levels of cortisol and interleukin-6 (IL-6) plasma. The findings are expected to support the development of complementary, low-cost, and non-pharmacological strategies for anxiety management.

Read the detailed description

Anxiety is one of the biggest causes of disability in the world, and many patients do not respond to conventional treatments. Due to this situation, studies were carried out to understand better understand the mechanisms of psychiatric disorders, and one of the alternatives found was the non-invasive brain stimulation with transcranial direct current (tDCS). The project in question aims to evaluate the effectiveness of tDCS-based intervention in adults with anxiety, comparing with a control group. The results will be measured through questionnaires and tests cognitive effects, as well as analyzes of physiological data and inflammatory markers. The study will be done through an experimental and a control group, with 49 men and women in each group. All data will be collected at the Neuromodulation laboratory at Hospital de Clínicas de Porto Alegre, under the coordination of Professor Wolnei Caumo. Participants will be recruited through previously registered patients on Neuromodulation laboratory at Hospital de Clínicas de Porto Alegre database, and the inclusion criteria and exclusion will be defined according to values of anxiety scales and other characteristics of health. The entire process will be conducted safely. Participants in the experimental and control will have their data collected on the first and last day of the intervention. Each participant will receive a placebo or control intervention of 20 sessions, between the first and the last, and will be blinded between groups.

Conditions: Anxiety
Being tested: 'Transcranial Direct Current Stimulation - tDCS
Keywords: anxiety, tDCS, IL-6, Cortisol, HRV, EEG
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

'Transcranial Direct Current Stimulation - tDCSDevice
Participants will receive by trained personnel, transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC). According to the international 10-20 EEG system, the anodal electrode will be placed over the left F3 position and the cathodal electrode over the right F4 position. Active stimulation will be delivered using a constant current of 2 milliamperes (mA) for 20 minutes per session. The intervention will consist of twelve consecutive daily sessions (Monday to Friday), totaling four week of treatment. A certified tDCS device will be used, programmed to deliver a ramp-up and ramp-down period of 30 seconds.
In the sham condition, the same electrode montage will be used; however, the device will automatically ramp down the current after 30 seconds, mimicking the initial tingling sensation without producing lasting neuromodulatory effects. This sham protocol is commonly used to ensure participant blinding in tDCS studies.

Study groups in NCT07116980
Study group	Role	What they receive
responds to the placebo effect Intervention: Transcranial Direct Current Stimulation - tDCS	Placebo comparator	Patients will receive tDCS stimulation treatment dorsolateral prefrontal cortex. According to the 10-20 EEG system, the anode will be placed on the left F3 and the cathode on the contralateral F4. Placebo stimulation uses a current of 2 milliamps for the first 30 seconds and again for the last 30 seconds. The tDCS application time will be 20 minutes Device: s-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it Device: a-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it Receives: Device: 'Transcranial Direct Current Stimulation - tDCS
No placebo effect responds Intervention: Transcranial Direct Current Stimulation - tDCS	Active comparator	Patients will receive tDCS stimulation treatment dorsolateral prefrontal cortex According to the 10-20 EEG system, the anode will be placed on the left F3 and the cathode on the contralateral F4. Active stimulation uses a current of 2 milliamps for 20 minutes. Device: s-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it Device: a-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it Receives: Device: 'Transcranial Direct Current Stimulation - tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Generalized Anxiety Symptoms as Assessed by the GAD-7 Scale
Change in anxiety symptoms will be assessed by the total change in the GAD-7 score, a 7-item self-administered scale that measures the severity of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Measured: 1 month

Secondary outcomes (6)

Change in the Anxiety Sensitivity Index-Revised (ASI-R) Total Score
The change in anxiety sensitivity will be assessed by the total change in the Anxiety Sensitivity Index-Revised (ASI-R) score, a 36-item questionnaire that measures the fear of anxiety-related sensations. Higher scores indicate greater anxiety sensitivity.
Measured: 1 month
Change in Pain Intensity as Measured by the Central Sensitization Inventory (CSI) score
The change in pain intensity will be assessed by the Central Sensitization Inventory (CSI), a 25-item self-report questionnaire that assesses common symptoms associated with central sensitization. The scale is scored from 0 to 100, with higher scores indicating higher levels of central sensitization.
Measured: 1 month
Change in Subjective Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) score
The change in subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a self-rated questionnaire that assesses sleep quality over the last month. The scale includes seven component scores, and a global score is derived, ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: 1 month
Change in Absolute Alpha Band Power (8-12 Hz) at Electrode Site [F3/F4/C3/C4/P3/P4] as Assessed by Electroencephalogram (EEG).
Absolute alpha band power will be calculated from resting EEG recordings and expressed in µV²/Hz. Recordings will be acquired from the [specific electrode site] electrode.
Measured: 1 month
Change in Heart Rate Variability (HRV) as Assessed by the Standard Deviation of NN Intervals (SDNN)
SDNN will be collected from 3-minute resting recordings and expressed in milliseconds (ms).
This specifies the exact HRV metric (SDNN) and its unit, making it clear and quantifiable
Measured: 1 month
Change in Interhemispheric Absolute Alpha Band Power Asymmetry (8-12 Hz) Between [F3 and F4 / C3 and C4 / P3 and P4] as Assessed by Electroencephalogram (EEG)
Interhemispheric absolute alpha band power asymmetry will be calculated from resting EEG recordings and expressed as a ratio. Recordings will be acquired from [F3 and F4 / C3 and C4 / P3 and P4] electrode pairs.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202325 Jun 2024

First posted12 Aug 2025
Study start21 Jun 2023
Primary completion30 Jan 2024
Study completion25 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Hospital de Clinicas de Porto AlegreThe 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: Randomised
Intervention model: Parallel groups
Model description: Double-blind, randomized, parallel-group, simulation-controlled clinical trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07116980
Sponsor's protocol ID: 69019123.3.0000.5327
Acronym: AnsitDCS
Status last verified: Aug 2025
First submitted: 18 Jun 2025
Last updated: 12 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Given the potential for this study to be extended in future research protocols involving different variables, the current stage is not appropriate for public data sharing.

Publications

Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
PubMed 27372845
Chalmers JA, Quintana DS, Abbott MJ, Kemp AH. Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014 Jul 11;5:80. doi: 10.3389/fpsyt.2014.00080. eCollection 2014.
PubMed 25071612
Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.
PubMed 27160468
Palm U, Hasan A, Strube W, Padberg F. tDCS for the treatment of depression: a comprehensive review. Eur Arch Psychiatry Clin Neurosci. 2016 Dec;266(8):681-694. doi: 10.1007/s00406-016-0674-9. Epub 2016 Feb 3.
PubMed 26842422
Shiozawa P, Leiva AP, Castro CD, da Silva ME, Cordeiro Q, Fregni F, Brunoni AR. Transcranial direct current stimulation for generalized anxiety disorder: a case study. Biol Psychiatry. 2014 Jun 1;75(11):e17-8. doi: 10.1016/j.biopsych.2013.07.014. Epub 2013 Aug 16. No abstract available.
PubMed 23958182
Brunoni AR, Vanderhasselt MA. Working memory improvement with non-invasive brain stimulation of the dorsolateral prefrontal cortex: a systematic review and meta-analysis. Brain Cogn. 2014 Apr;86:1-9. doi: 10.1016/j.bandc.2014.01.008. Epub 2014 Feb 8.
PubMed 24514153

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biological and Psychological Markers After Trancranial Electrical Stimulation in Adults With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT07116980
Acronym / sponsor ID: AnsitDCS / 69019123.3.0000.5327
Conditions: Anxiety
Keywords: anxiety, tDCS, IL-6, Cortisol, HRV, EEG
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Hospital de Clinicas de Porto AlegreUniversity, hospital or other
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study start: 21 Jun 2023 (actual)
Primary completion: 30 Jan 2024 (actual)
Study completion: 25 Jun 2024 (actual)
First posted: 12 Aug 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Double-blind, randomized, parallel-group, simulation-controlled clinical trial

Arm	Type	Receives
responds to the placebo effect Intervention: Transcranial Direct Current Stimulation - tDCS	Placebo comparator	Device: 'Transcranial Direct Current Stimulation - tDCSPatients will receive tDCS stimulation treatment dorsolateral prefrontal cortex. According to the 10-20 EEG system, the anode will be placed on the left F3 and the cathode on the contralateral F4. Placebo stimulation uses a current of 2 milliamps for the first 30 seconds and again for the last 30 seconds. The tDCS application time will be 20 minutes Device: s-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it Device: a-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
No placebo effect responds Intervention: Transcranial Direct Current Stimulation - tDCS	Active comparator	Device: 'Transcranial Direct Current Stimulation - tDCSPatients will receive tDCS stimulation treatment dorsolateral prefrontal cortex According to the 10-20 EEG system, the anode will be placed on the left F3 and the cathode on the contralateral F4. Active stimulation uses a current of 2 milliamps for 20 minutes. Device: s-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it Device: a-tDCS - Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Adults under the age of 18;
GAD-7 ≥ 10
Possibility of being present on previously agreed days.

Key exclusion criteria (7 listed)

Being in psychopharmacological treatment for depression;
HAM-D≥23 scale;
have a self-reported severe disorder (psychosis, schizophrenia, substance abuse, major depression);
having had seizures and epilepsy;
having presented substance use disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months;

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 Direct Current Stimulation - tDCSParticipants will receive by trained personnel, transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC). According to the international 10-20 EEG system, the anodal electrode will be placed over the left F3 position and the cathodal electrode over the right F4 position. Active stimulation will be delivered using a constant current of 2 milliamperes (mA) for 20 minutes per session. The intervention will consist of twelve consecutive daily sessions (Monday to Friday), totaling four week of treatment. A certified tDCS device will be used, programmed to deliver a ramp-up and ramp-down period of 30 seconds. In the sham condition, the same electrode montage will be used; however, the device will automatically ramp down the current after 30 seconds, mimicking the initial tingling sensation without producing lasting neuromodulatory effects. This sham protocol is commonly used to ensure participant blinding in tDCS studies.	Device	No placebo effect responds Intervention: Transcranial Direct Current Stimulation - tDCS, responds to the placebo effect Intervention: Transcranial Direct Current Stimulation - tDCS

Primary outcome

Change in Generalized Anxiety Symptoms as Assessed by the GAD-7 Scale
Time frame: 1 month
Change in anxiety symptoms will be assessed by the total change in the GAD-7 score, a 7-item self-administered scale that measures the severity of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.

6 secondary outcomes

Change in the Anxiety Sensitivity Index-Revised (ASI-R) Total Score
Time frame: 1 month
Change in Pain Intensity as Measured by the Central Sensitization Inventory (CSI) score
Time frame: 1 month
Change in Subjective Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) score
Time frame: 1 month
Change in Absolute Alpha Band Power (8-12 Hz) at Electrode Site [F3/F4/C3/C4/P3/P4] as Assessed by Electroencephalogram (EEG).
Time frame: 1 month
Change in Heart Rate Variability (HRV) as Assessed by the Standard Deviation of NN Intervals (SDNN)
Time frame: 1 month
Change in Interhemispheric Absolute Alpha Band Power Asymmetry (8-12 Hz) Between [F3 and F4 / C3 and C4 / P3 and P4] as Assessed by Electroencephalogram (EEG)
Time frame: 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Background: PubMed 27372845Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.
Background: PubMed 25071612Chalmers JA, Quintana DS, Abbott MJ, Kemp AH. Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014 Jul 11;5:80. doi: 10.3389/fpsyt.2014.00080. eCollection 2014.
Background: PubMed 27160468Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.
Background: PubMed 26842422Palm U, Hasan A, Strube W, Padberg F. tDCS for the treatment of depression: a comprehensive review. Eur Arch Psychiatry Clin Neurosci. 2016 Dec;266(8):681-694. doi: 10.1007/s00406-016-0674-9. Epub 2016 Feb 3.
Background: PubMed 23958182Shiozawa P, Leiva AP, Castro CD, da Silva ME, Cordeiro Q, Fregni F, Brunoni AR. Transcranial direct current stimulation for generalized anxiety disorder: a case study. Biol Psychiatry. 2014 Jun 1;75(11):e17-8. doi: 10.1016/j.biopsych.2013.07.014. Epub 2013 Aug 16. No abstract available.
Background: PubMed 24514153Brunoni AR, Vanderhasselt MA. Working memory improvement with non-invasive brain stimulation of the dorsolateral prefrontal cortex: a systematic review and meta-analysis. Brain Cogn. 2014 Apr;86:1-9. doi: 10.1016/j.bandc.2014.01.008. Epub 2014 Feb 8.
Individual participant dataSharing planned: No. Given the potential for this study to be extended in future research protocols involving different variables, the current stage is not appropriate for public data sharing.

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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. This study is not recruiting at the moment.

Wolnei Caumo, PhD study director

Hospital de Clinicas de Porto Alegre

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 Direct Current Stimulation - tDCS in people with Anxiety, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 12 Aug 2025. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Generalized Anxiety Symptoms as Assessed by the GAD-7 Scale (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07116980, which also lists 6 linked publications.

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 12 Aug 2025.