Biological and Psychological Markers After Intervention in Adults With GAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-21

Study Completion Date

2024-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study.

NCT02900053

Post-traumatic Stress Disorder

COMPLETED NA

CES for the Treatment of GAD in Young Adults

NCT06124014

Generalized Anxiety Disorder

ACTIVE_NOT_RECRUITING NA

Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder

NCT01681329

Generalized Anxiety Disorder

COMPLETED NA

Implementation of Psychological Treatment in Generalized Anxiety

NCT03079336

Generalized Anxiety Disorder

COMPLETED NA

Assessing the Clinical Utility of tACS

NCT03305328

Anxiety Disorders and Symptoms Sensory Disorders Hypervigilance +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized, parallel-group, simulation-controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The researcher will receive equipment already programmed by a research assistant, therefore, the researcher who will deliver the tDCS to perform the stimulation will not know the programmed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent assessors who will not participate in consultations where guidance on the use of tDCS will be provided will be trained to assess follow-up outcomes. Patients will not know the type of intervention received, as the sham condition produces a stimulus, but without the expected effects. Blinding will be evaluated at the end of treatment using a standardized instrument.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

responds to the placebo effect Intervention: Transcranial Direct Current Stimulation - tDCS

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

Group Type PLACEBO_COMPARATOR

'Transcranial Direct Current Stimulation - tDCS

Intervention Type DEVICE

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.

No placebo effect responds Intervention: Transcranial Direct Current Stimulation - tDCS

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

Group Type ACTIVE_COMPARATOR

'Transcranial Direct Current Stimulation - tDCS

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

'Transcranial Direct Current Stimulation - tDCS

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes