Effects of Transcranial Electrical Stimulation in Chronic Stress

NCT06813209 | Not Yet Recruiting

• 1 other identifier: 1328
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Sleep

Keywords

Transcranial electrical stimulation by direct current; tDCS; non-invasive vagus nerve stimulation; stress; tVNS

Outcome Measures

Primary Outcomes (2)

• Stress Symptoms assessment

  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

  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 Outcomes (2)

• Distress Assessment

  From enrollment to followup at 1 month

• Sleep Quality

  From enrollment to follow up at 1 month

Study Arms (4)

tDCS True Modulation

EXPERIMENTAL

Participants will be delivered true treatment for 20 minutes each session

Device: tDCS

tDCS Sham group

SHAM COMPARATOR

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

tVNS True

EXPERIMENTAL

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

tVNS Sham

SHAM COMPARATOR

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

Interventions

tDCS DEVICE

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.

Also known as: transcranial Direct Current Stimulation

tDCS Sham group; tDCS True Modulation

tVNS DEVICE

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.

Also known as: transcutaneous Vagus Nerve Stimulation

tVNS Sham; tVNS True

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• Universidade Federal de Alfenas: collaborator

Study Sites (1)

Egas Moniz Scholl Of Health and Science

Almada, Setúbal District, Portugal

Location

Related Publications (3)

• Brunoni AR, Nitsche MA, Bolognini N, Bikson M, Wagner T, Merabet L, Edwards DJ, Valero-Cabre A, Rotenberg A, Pascual-Leone A, Ferrucci R, Priori A, Boggio PS, Fregni F. Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions. Brain Stimul. 2012 Jul;5(3):175-195. doi: 10.1016/j.brs.2011.03.002. Epub 2011 Apr 1.

  PMID: 22037126 BACKGROUND

• Alyan E, Saad NM, Kamel N, Yusoff MZ, Zakariya MA, Rahman MA, Guillet C, Merienne F. Frontal Electroencephalogram Alpha Asymmetry during Mental Stress Related to Workplace Noise. Sensors (Basel). 2021 Mar 11;21(6):1968. doi: 10.3390/s21061968.

  PMID: 33799722 BACKGROUND

• Loftus AM, Yalcin O, Baughman FD, Vanman EJ, Hagger MS. The impact of transcranial direct current stimulation on inhibitory control in young adults. Brain Behav. 2015 May;5(5):e00332. doi: 10.1002/brb3.332. Epub 2015 Mar 19.

  PMID: 25874165 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Luciano Maia Alves Ferreira, PhD

CONTACT

+351913548646; lucianomaia@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: February 6, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)