Effects of Transcranial Electrical Stimulation in Chronic Stress (NEUROSTIM)

February 3, 2025 updated by: Egas Moniz - Cooperativa de Ensino Superior, CRL

Effects of Transcranial Electrical Stimulation by Continuous Current on the Right and Left Dorsolateral Prefrontal Cortex Associated or Not with Non-invasive Vagus Nerve Stimulation in Adult Individuals with Chronic Stress

This clinical trial aims to determine if Transcranial electrical stimulation by direct current (tDCS) and transauricular Vagus Nerve Stimulation (tVNS) treatments are effective in reducing stress symptoms, distress and improving sleep quality in adults. The main questions it aims to answer are:

  • Determine if tDCS effectively reduces the intensity of stress symptoms in adults.
  • Determine if tDCS is effective in reducing levels of distress in adults.
  • Determine if tDCS is effective in improving sleep quality.
  • Determine if tVNS is effective in reducing the intensity of stress symptoms in adults.
  • Determine if tVNS is effective in reducing levels of distress in adults.
  • Determine if tVNS is effective in improving sleep quality.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Stress is a disorder that significantly impacts the lives of affected individuals. Pharmacological treatment has limitations, justifying the search for non-pharmacological interventions. tDCS is a technique that modulates neuronal excitability and has shown promising results in various disorders.

Psychological stress affects a wide range of brain functions and poses risks for many mental disorders. However, effective therapies to alleviate or reverse its deleterious effects are lacking. Given that the pathophysiology of stress involves brain regions such as the prefrontal cortex, central amygdaloid nucleus, amygdala, medial amygdaloid nucleus, and ventral hippocampus, thus making the condition complex, there is a need for studies evaluating the effects of this intervention. We aim to contribute to the understanding of the role of tDCS and tVNS in managing stress.

Before participating in this research, volunteers will receive all information related to the study's objectives and methodological procedures. After agreeing to participate, they will sign the Informed Consent Form.

Study Location Patients will be selected following an evaluation based on inclusion and exclusion criteria and referred to the Clinic School of the Federal University of Alfenas (MG/Brazil), at the Laboratory of Neuroscience, Neuromodulation, and Pain Study (LANNED), located in the city of Alfenas, Minas Gerais, and at the Neuromodulation and Pain Unit (UNP) by the Egas Moniz Center for Interdisciplinary Research (CiiEM) of the Egas Moniz School of Health and Science, in the municipality of Almada, Setúbal - Portugal.

The design of the double-blind randomized clinical trial will be conducted, ensuring that participants are randomly assigned to experimental and sham groups and that the researcher applying the technique and the participants will not be aware of the allocation. The protocol will consist of 5 consecutive sessions of 20 minutes each. Data related to the anamnesis, ISSL, PSS-10, and PSQI will be evaluated at five different time points (Figure 1): before the intervention (T0), immediately after the end of the intervention (T1), and four weeks (T2) after the intervention ends (follow-up), following the CONSORT/2010 recommendations.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
    • Setubal
      • Almada, Setubal, Portugal
        • Egas Moniz Scholl Of Health and Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • individuals previously diagnosed with stress.
  • Obtain a score above 4 on the Lipp Adult Stress Symptom Inventory (ISSL);
  • Must be able to read and understand the purpose of the research and respond to the assessment instruments.
  • Must acknowledge and agree with the informed consent form.

Exclusion Criteria:

  • smokers;
  • be pregnant;
  • initiation and/or change in psychotropic drug dosage in the last three months;
  • use of anxiolytics or antidepressants;
  • substance dependence;
  • history of dizziness or seizures;
  • signs of severity and/or indications for hospitalization or psychotherapy;
  • diagnosis of depression; diagnosis of anxiety; bipolar mood disorder with depressive, manic, or hypomanic symptoms in the past year;
  • schizophrenia or other psychotic disorders;
  • autism;
  • diagnosis of epilepsy or use of anticonvulsants;
  • contraindications for tDCS (metal implants, tumor, previous brain surgery, significant cranioencephalic anatomical alterations);
  • contraindications for non-invasive vagus nerve stimulation (cochlear implant, ear plastic surgery, ear malformation);
  • adverse effects detected in the group treated with tDCS and tVNS, including itching, tingling, headache, burning sensation, and discomfort.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS True Modulation
Participants will be delivered true treatment for 20 minutes each session
Device: tDCS
For true tDCS, the technique will be performed with the anode over the right dorsolateral prefrontal cortex and the cathode over the left dorsolateral prefrontal cortex, positioned at F4 and F3, respectively, according to the International 10/20 Electrode Placement System. The current intensity will be set to 2 milliamperes (mA) for 20 minutes over five consecutive days.
Other Names:
  • transcranial Direct Current Stimulation
Sham Comparator: tDCS Sham group
Sham group will be delivers a simulated treatment; the current will be applied for only 60 seconds, with the setup remaining in place for 20 minutes.
Device: tDCS
For true tDCS, the technique will be performed with the anode over the right dorsolateral prefrontal cortex and the cathode over the left dorsolateral prefrontal cortex, positioned at F4 and F3, respectively, according to the International 10/20 Electrode Placement System. The current intensity will be set to 2 milliamperes (mA) for 20 minutes over five consecutive days.
Other Names:
  • transcranial Direct Current Stimulation
Experimental: tVNS True
For true tVNS stimulation, the technique will be performed with the electrodes positioned on the upper concha of the left ear, using gel for better current distribution.
Device: tVNS
For true tVNS stimulation, the technique will be performed with the electrodes positioned on the upper concha of the left ear, using gel for better current distribution.
Other Names:
  • transcutaneous Vagus Nerve Stimulation
Sham Comparator: tVNS Sham
For sham tVNS stimulation, the technique will be performed in the same way as true stimulation; however, the device will be programmed to deliver 0 Hz.
Device: tVNS
For true tVNS stimulation, the technique will be performed with the electrodes positioned on the upper concha of the left ear, using gel for better current distribution.
Other Names:
  • transcutaneous Vagus Nerve Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress Symptoms assessment
Time Frame: From enrollment to follow up at 1 month
Stress will be assessed using self reported Lipp's Inventory of Stress Symptoms for Adults (LISS). The LISS consists of a questionnaire that assesses physical and psychological symptoms of stress across three time frames: alert (ranging from 0 to 15), resistance (ranging from 0 to 15), quasi-exhaustion or exhaustion (ranging from 0 to 23). Higher scores mean a worse outcome.
From enrollment to follow up at 1 month
Perceived Stress assessment
Time Frame: From enrollment to follow up at 1 month
Perceived Stress will be assessed using the Perceived Stress Scale (PSS-10). The test ranges from 0 (min) to 40 (max). Higher scores mean a a worst outcome.
From enrollment to follow up at 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress Assessment
Time Frame: From enrollment to followup at 1 month
Distress will be assessed using the Kessler Psychological Distress Scale (K10). the scale range is from 10 (min) to 50 (max). Higher scores mean a worse outcome.
From enrollment to followup at 1 month
Sleep Quality
Time Frame: From enrollment to follow up at 1 month
Stress will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21. Higher scores mean a worse outcome
From enrollment to follow up at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Collaborators

Universidade Federal de Alfenas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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