Persistent Post-concussive SymptomstaVNS-PPCSNCT07017257
Transcutaneous Auricular Vagus Nerve Stimulation for Persistent Post-concussion Symptoms
A study testing Active taVNS in people with Persistent Post-concussive Symptoms, run by University of Liege at 1 site in Belgium.
Trial summary
Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Post-concussive Symptoms
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 28 May 2025to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65;
- Between 4 weeks and 1-year post-diagnosis of a concussion;
- Score equal or above 16 on the Rivermead Post-Concussion Questionnaire;
- Intact skin at the electrode site.
Who cannot join
- History of chronic neurological or psychological disorders (still untreated 6 months preceding inclusion);
- Pregnancy or breastfeeding;
- Presence of an active implant (e.g., pacemaker, cochlear implant);
- History of myocardial infarction or cardiac arrhythmia;
- Excessive alcohol consumption (> 14 drinks per week) and/or drug (> 1x/week) use within the past 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, Liège, 4000
Nicolas Lejeune, MD, PhD, +3243663795, nicolas.lejeune@uliege.be
About this study
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial
Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, holds promise as a therapeutic option by leveraging the bottom-up modulation of brain activity via the auricular branch of the vagus nerve. This study aims to evaluate the neurophysiological and clinical effects of taVNS on brain activity and symptomatology in patients with PPCS through a randomized, controlled, double-blind trial.
Read the detailed description
PPCS occur in 30-50% of individuals following a concussion and can persist for months, causing somatic complaints (e.g., headaches and dizziness), cognitive impairments (e.g., memory and concentration issues), emotional disturbances (e.g., anxiety and depression), and sleep disorders. Despite their long-term consequences, effective treatments for PPCS remain scarce. Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising non-invasive technique that stimulates the auricular branch of the vagus nerve to induce bottom-up effects on brain activity, potentially alleviating PPCS.
This randomized, controlled, double-blind clinical trial will evaluate the cumulative and direct neurophysiological and clinical effects of taVNS (tVNS Technologies GmbH, Germany) in 48 patients aged 18 to 65 years who experienced a diagnosed concussion between 4 weeks and 1 year prior to enrollment and suffer from PPCS. Participants will be randomized to either an active taVNS group or a sham stimulation group.
Patients will undergo a total of 15 taVNS sessions over two weeks, including two visits at the University Hospital of Liège (first and last session) and 13 self-administered sessions at home. Symptom severity, including headaches, depression, anxiety, sleep disturbances, and overall quality of life, will be measured using validated questionnaires, while cognitive function (i.e., attention, working memory, executive functions) will be assessed through neuropsychological tests. Additionally, electroencephalographic (EEG) and electrocardiogram (ECG) recordings will be used to measure changes in brain activity and heart rate, respectively, focusing on alterations in power spectral density and functional connectivity patterns that may correlate with clinical improvements.
Follow-up assessments will occur one-month post-intervention via a phone call to collect questionnaires assessing symptom severity and quality of life.
This protocol aims to provide robust evidence on the efficacy and mechanisms of taVNS for PPCS while advancing our understanding of the neurophysiological changes associated with this therapeutic approach.
Interim analyses will be conducted after the inclusion of 24 patients to evaluate preliminary data. These analyses will also allow for adjustments to the sample size, if necessary, to maintain the study's statistical power.
Patients who did not complete 80% of the sessions (12 sessions) will be excluded from the study.
- Conditions
- Persistent Post-concussive Symptoms
- Being tested
- Active taVNS, Sham taVNS
- Keywords
- Vagus nerve stimulation, Transcutaneous electrical nerve stimulation, Non-invasive brain stimulation, Persistent post-concussive symptoms, High-density EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active taVNSDevice
Patients will receive active taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will range from 1 to 3 mA, adjusted to the patient's pain threshold, with a pulse width of 250 μsec and a frequency of 25Hz.
Sham taVNSDevice
Patients will receive sham taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will be fixed at 100 µA, with a pulse width of 250 μsec and a frequency of 25 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | Patients will undergo 15 sessions of 30-min active taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home.
To monitor safety, participants will report any side effects after each session.
To monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response.
A follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview. Receives: Device: Active taVNS |
| Sham taVNS | Sham comparator | Patients will undergo 15 sessions of 30-min sham taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home.
To monitor safety, participants will report any side effects after each session.
To monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response.
A follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview. Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of taVNS on symptom severity in patients with PPCS
The investigators will evaluate the effects of taVNS on the severity of PPCS, as measured by the Rivermead Post-Concussion Questionnaire (RPQ). The RPQ consists of 16 items scored on a 5-point Likert scale (0 = not experienced at all, 4 = severe problem). Total scores range from 0 to 64, with higher scores indicating worse symptom severity. The RPQ will be administered at four time points: baseline, mid-treatment, post-intervention, and one-month follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on brain activity in patients with PPCS
The investigators will assess the effects of taVNS on brain activity using electroencephalography (EEG). Specific metrics analyzed will include:
- Power spectral density across frequency bands: delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-45 Hz).
- Functional connectivity patterns across cortical regions based on EEG coherence or phase-locking value.
These parameters will be extracted from EEG data collected before and after the first and final taVNS sessions.
Measured: From enrollment to the end of the treatment at 2 weeks.
Secondary outcomes (10)
Effects of taVNS on cognitive functions in patients with PPCS
Cognitive performance will be assessed using the Test of Attentional Performance (TAP v2.3.1). Individual domain scores will be reported according to test-specific metrics. This assessment will be performed at baseline and after the intervention.
Measured: From enrollment to the end of the treatment at 2 weeks.
Effects of taVNS on verbal memory in patients with PPCS
The Rey Auditory Verbal Learning Test (RAVLT) will be performed to evaluate verbal memory. This test will be conducted at baseline and post-intervention. Individual domain scores will be reported. This assessment will be performed at baseline and after the intervention.
Measured: From enrollement to the end of the treatment at 2 weeks.
Effects of taVNS on heart rate variability in patients with PPCS
The investigators will assess heart rate variability (HRV) using electrocardiogram (ECG) recordings. Heart rate variability measurements will be performed before and after the first and final taVNS sessions.
Measured: From enrollment to the end of the treatment at 2 weeks.
Effects of taVNS on headaches in patients with PPCS
The Headache Impact Test (HIT-6) will be used to evaluate the severity of headaches. Scores range from 36 to 78, with higher scores indicating worse impact. This questionnaire will be administered at three time points: baseline, post-intervention and at one-month follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effect of taVNS on sleep quality in patients with PPCS
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) (score range: 0-21; higher scores = worse sleep quality). This questionnaire will be administered at baseline, post-intervention, and follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on daytime sleepiness in patients with PPCS
Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS) (score range: 0-24; higher scores = greater daytime sleepiness). This questionnaire will be administered at baseline, post-intervention, and follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on sleep changes in patients with PPCS
Changes in sleep will be assessed using the Sleep and Concussion Questionnaire (SCQ) (score range: 0-36; higher scores = greater severity and frequency of sleep disturbances). This questionnaire will be administered at baseline, post-intervention, and follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on depressive symptoms in patients with PPCS
Depressive symptoms will be evaluated using the Beck Depression Inventory (BDI-II) (score range: 0-63; higher scores = more severe depression). This questionnaire will be administered at baseline, post-intervention, and follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on anxiety symptoms in patients with PPCS
Anxiety symptoms will be evaluated using the Beck Anxiety Inventory (BAI) (score range: 0-63; higher scores = more severe anxiety) This questionnaire will be administered at baseline, post-intervention, and follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on quality of life in patients with PPCS
The Quality of Life after Brain Injury Questionnaire (QOLIBRI) will be used to assess quality of life. The total score ranges from 0 to 100, with higher scores indicating better quality of life. This questionnaire will be administered at three time points: baseline, post-intervention and at one-month follow-up.
Measured: From enrollment to the end of the study at 6 weeks (including follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start28 May 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Post-concussive SymptomsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Sart Tilman, Liege
- Responsible party
- Principal investigator, Aurore Thibaut, University of Liege
- Investigators
- Nicolas Lejeune, MD, PhD, Principal investigator, NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of LiègeAurore Thibaut, PT, PhD, Principal investigator, NeuroRecovery Lab, GIGA-Consciousness, GIGA Institute, University of Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017257
- Sponsor's protocol ID
- 2024-373
- Acronym
- taVNS-PPCS
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07017257
- Acronym / sponsor ID
- taVNS-PPCS / 2024-373
- Conditions
- Persistent Post-concussive Symptoms
- Keywords
- Vagus nerve stimulation, Transcutaneous electrical nerve stimulation, Non-invasive brain stimulation, Persistent post-concussive symptoms, High-density EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- University Hospital Sart Tilman, Liege
- Study start
- 28 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 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.
Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, holds promise as a therapeutic option by leveraging the bottom-up modulation of brain activity via the auricular branch of the vagus nerve. This study aims to evaluate the neurophysiological and clinical effects of taVNS on brain activity and symptomatology in patients with PPCS through a randomized, controlled, double-blind trial.
Detailed description
PPCS occur in 30-50% of individuals following a concussion and can persist for months, causing somatic complaints (e.g., headaches and dizziness), cognitive impairments (e.g., memory and concentration issues), emotional disturbances (e.g., anxiety and depression), and sleep disorders. Despite their long-term consequences, effective treatments for PPCS remain scarce. Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising non-invasive technique that stimulates the auricular branch of the vagus nerve to induce bottom-up effects on brain activity, potentially alleviating PPCS.
This randomized, controlled, double-blind clinical trial will evaluate the cumulative and direct neurophysiological and clinical effects of taVNS (tVNS Technologies GmbH, Germany) in 48 patients aged 18 to 65 years who experienced a diagnosed concussion between 4 weeks and 1 year prior to enrollment and suffer from PPCS. Participants will be randomized to either an active taVNS group or a sham stimulation group.
Patients will undergo a total of 15 taVNS sessions over two weeks, including two visits at the University Hospital of Liège (first and last session) and 13 self-administered sessions at home. Symptom severity, including headaches, depression, anxiety, sleep disturbances, and overall quality of life, will be measured using validated questionnaires, while cognitive function (i.e., attention, working memory, executive functions) will be assessed through neuropsychological tests. Additionally, electroencephalographic (EEG) and electrocardiogram (ECG) recordings will be used to measure changes in brain activity and heart rate, respectively, focusing on alterations in power spectral density and functional connectivity patterns that may correlate with clinical improvements.
Follow-up assessments will occur one-month post-intervention via a phone call to collect questionnaires assessing symptom severity and quality of life.
This protocol aims to provide robust evidence on the efficacy and mechanisms of taVNS for PPCS while advancing our understanding of the neurophysiological changes associated with this therapeutic approach.
Interim analyses will be conducted after the inclusion of 24 patients to evaluate preliminary data. These analyses will also allow for adjustments to the sample size, if necessary, to maintain the study's statistical power.
Patients who did not complete 80% of the sessions (12 sessions) will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: Active taVNSPatients will undergo 15 sessions of 30-min active taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home. To monitor safety, participants will report any side effects after each session. To monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response. A follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview. |
| Sham taVNS | Sham comparator | Device: Sham taVNSPatients will undergo 15 sessions of 30-min sham taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home. To monitor safety, participants will report any side effects after each session. To monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response. A follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65;
- Between 4 weeks and 1-year post-diagnosis of a concussion;
- Score equal or above 16 on the Rivermead Post-Concussion Questionnaire;
- Intact skin at the electrode site.
Key exclusion criteria (5 listed)
- History of chronic neurological or psychological disorders (still untreated 6 months preceding inclusion);
- Pregnancy or breastfeeding;
- Presence of an active implant (e.g., pacemaker, cochlear implant);
- History of myocardial infarction or cardiac arrhythmia;
- Excessive alcohol consumption (> 14 drinks per week) and/or drug (> 1x/week) use within the past 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 |
|---|---|---|
| Active taVNSPatients will receive active taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will range from 1 to 3 mA, adjusted to the patient's pain threshold, with a pulse width of 250 μsec and a frequency of 25Hz. | Device | Active taVNS |
| Sham taVNSPatients will receive sham taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will be fixed at 100 µA, with a pulse width of 250 μsec and a frequency of 25 Hz. | Device | Sham taVNS |
Primary outcome
Effects of taVNS on symptom severity in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
The investigators will evaluate the effects of taVNS on the severity of PPCS, as measured by the Rivermead Post-Concussion Questionnaire (RPQ). The RPQ consists of 16 items scored on a 5-point Likert scale (0 = not experienced at all, 4 = severe problem). Total scores range from 0 to 64, with higher scores indicating worse symptom severity. The RPQ will be administered at four time points: baseline, mid-treatment, post-intervention, and one-month follow-up.
Effects of taVNS on brain activity in patients with PPCS
Time frame: From enrollment to the end of the treatment at 2 weeks.
The investigators will assess the effects of taVNS on brain activity using electroencephalography (EEG). Specific metrics analyzed will include: * Power spectral density across frequency bands: delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-45 Hz). * Functional connectivity patterns across cortical regions based on EEG coherence or phase-locking value. These parameters will be extracted from EEG data collected before and after the first and final taVNS sessions.
10 secondary outcomes
Effects of taVNS on cognitive functions in patients with PPCS
Time frame: From enrollment to the end of the treatment at 2 weeks.
Effects of taVNS on verbal memory in patients with PPCS
Time frame: From enrollement to the end of the treatment at 2 weeks.
Effects of taVNS on heart rate variability in patients with PPCS
Time frame: From enrollment to the end of the treatment at 2 weeks.
Effects of taVNS on headaches in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
Effect of taVNS on sleep quality in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on daytime sleepiness in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on sleep changes in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on depressive symptoms in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on anxiety symptoms in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
Effects of taVNS on quality of life in patients with PPCS
Time frame: From enrollment to the end of the study at 6 weeks (including follow-up).
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 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Persistent Post-concussive Symptoms
Not yet recruiting
SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
Persistent Post-concussive Symptoms, Post Traumatic Headache
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.
Nicolas Lejeune, MD, PhD principal investigator
NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of Liège
Aurore Thibaut, PT, PhD principal investigator
NeuroRecovery Lab, GIGA-Consciousness, GIGA Institute, University of Liège
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active taVNS in people with Persistent Post-concussive Symptoms, run by University of Liege at 1 site in Belgium.
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 5 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 Belgium. 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 Mélanie Louras, MSc (+32479925739, melanie.louras@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of taVNS on symptom severity in patients with PPCS (time frame: From enrollment to the end of the study at 6 weeks (including follow-up).). 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?
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 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.