StressNEUROSTIMNCT06813209
Effects of Transcranial Electrical Stimulation in Chronic Stress
A study testing tDCS and tVNS in people with Stress and Sleep, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- tDCS and tVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2025to Apr 2027
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Egas Moniz Scholl Of Health and Science
Almada, Setúbal District
About this study
Official title: 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.
Read the 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.
- Being tested
- tDCS, tVNS
- Keywords
- Transcranial electrical stimulation by direct current, tDCS, non-invasive vagus nerve stimulation, stress, tVNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called transcranial Direct Current Stimulation
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.
tVNSDevice
Also called transcutaneous Vagus Nerve Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS True Modulation | Experimental | Participants will be delivered true treatment for 20 minutes each session Receives: 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. Receives: 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. Receives: 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. Receives: Device: tVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to follow up at 1 month
Secondary outcomes (2)
Distress Assessment
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.
Measured: From enrollment to followup at 1 month
Sleep Quality
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
Measured: From enrollment to follow up at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Alfenas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813209
- Sponsor's protocol ID
- 1328
- Acronym
- NEUROSTIM
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22037126Alyan 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.
PubMed 33799722Loftus 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.
PubMed 25874165
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06813209
- Acronym / sponsor ID
- NEUROSTIM / 1328
- Keywords
- Transcranial electrical stimulation by direct current, tDCS, non-invasive vagus nerve stimulation, stress, tVNS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- Universidade Federal de Alfenas
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Feb 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS True Modulation | Experimental | Device: tDCSParticipants will be delivered true treatment for 20 minutes each session |
| tDCS Sham group | Sham comparator | Device: tDCSSham 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. |
| tVNS True | Experimental | Device: tVNSFor 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. |
| tVNS Sham | Sham comparator | Device: tVNSFor 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- smokers;
- be pregnant;
- initiation and/or change in psychotropic drug dosage in the last three months;
- use of anxiolytics or antidepressants;
- substance dependence;
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 |
|---|---|---|
| tDCSAlso: transcranial Direct Current StimulationFor 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. | Device | tDCS Sham group, tDCS True Modulation |
| tVNSAlso: transcutaneous Vagus Nerve StimulationFor 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 Sham, tVNS True |
Primary outcome
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.
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.
2 secondary outcomes
Distress Assessment
Time frame: From enrollment to followup at 1 month
Sleep Quality
Time frame: From enrollment to follow up at 1 month
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 6 Feb 2025.
- Results publication: PubMed 22037126Brunoni 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.
- Results publication: PubMed 33799722Alyan 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.
- Results publication: PubMed 25874165Loftus 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and tVNS in people with Stress and Sleep, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 4 inclusion and 14 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: opening soon, as of the sponsor's last update on 6 Feb 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 Portugal. 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?
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 Luciano Maia Alves Ferreira, PhD (+351913548646, lucianomaia@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Symptoms assessment (time frame: From enrollment to follow up at 1 month). 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?
On the ClinicalTrials.gov record for NCT06813209, which also lists 3 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 6 Feb 2025.