Patients With Persistent Post-concussion SymptomsStim-PPCSNCT07895797
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
A study testing tDCS 8 channels in people with Patients With Persistent Post-concussion Symptoms, run by University of Liege at 1 site in Belgium.
Trial summary
In this randomized, sham-controlled, two-group, parallel, single-session study, the investigators aim to identify EEG biomarkers associated with cerebellar transcranial direct current stimulation (tDCS) in patients with persistent post-concussion symptoms (PPCS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Persistent Post-concussion Symptoms
- What is being tested?
- tDCS 8 channels
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2026to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 18 years or older;
- Have received a medical diagnosis of concussion within the 12 months prior to recruitment;
- Exhibit persistent post-concussion symptoms (PPCS) with a score ≥16 on the Rivermead Post-Concussion Symptoms Questionnaire
Who cannot join
- Identified risk for tDCS exposure according to the Transcranial Direct Current Stimulation Safety Screening Tool
- Neurological or psychiatric disorders with a prior medical diagnosis that could alter brain network connectivity before the concussion
- Use of medications (antidepressants, anxiolytics, antipsychotics, antiepileptics) that may affect brain connectivity.
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
Centre Neurologique et de réadaptation Fonctionnelle
Tinlot, Liege, 4557
Lejeune Nicolas, +32043232323, nicolas.lejeune@uliege.be
About this study
Official title: Identification of EEG Biomarkers Associated With Transcranial Direct Current Stimulation in Patients With Persistent Post-Concussion Symptoms
In this randomized, sham-controlled, two-group, parallel, single-session study, the investigators aim to identify EEG biomarkers associated with cerebellar transcranial direct current stimulation (tDCS) in patients with persistent post-concussion symptoms (PPCS). Cerebellar tDCS will be used to modulate brain network connectivity, which is known to be altered in PPCS. The study will include 38 participants, each completing a single session including EEG recordings before and after stimulation. Participants will be randomly assigned to one of two conditions: 1) active cerebellar tDCS, or 2) sham stimulation.By focusing on EEG functional connectivity and related signal metrics, this study aims to better understand the neural mechanisms of cerebellar tDCS and support the development of targeted interventions for patients with PPCS.
- Being tested
- tDCS 8 channels, sham tDCS 8 channels
- Keywords
- electroencephalography, persistent post-concussion symptoms, transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS 8 channelsDevice
Transcranial direct current stimulation is a non-invasive brain stimulation technique that delivers a weak direct electrical current through scalp electrodes to modulate neuronal excitability (<2mA). Cerebellar tDCS will be administered using an 8-channel montage optimized with the Stimweaver software (Neuroelectrics, Barcelona, Spain) to maximize current density over the cerebellum while minimizing off-target effects. A constant direct current will be applied for 20 minutes, with a 30-second ramp-up at the beginning and a 30-second ramp-down at the end. Other Name:
sham tDCS 8 channelsDevice
Transcranial direct current stimulation is a non-invasive brain stimulation technique that delivers a weak direct electrical current through scalp electrodes to modulate neuronal excitability (<2 mA). The device used has a sham setting that allows sham stimulation to be delivered while the interventionist remains blinded.Other Name:
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Active tDCS participants will receive high-definition cerebellar transcranial direct current stimulation using a multi-electrode montage optimized to target bilateral cerebellar regions. The electrode configuration is identical across conditions and has been defined using computational modeling to maximize focality while limiting current spread to adjacent areas. The stimulation consists of a 30-second ramp-up phase, followed by 20 minutes of continuous stimulation, and a 30-second ramp-down phase. Receives: Device: tDCS 8 channels |
| Sham tDCS | Sham comparator | Sham tDCS participants will undergo the same high-definition cerebellar electrode montage as the active tDCS group, ensuring identical setup and participant experience. However, no sustained current is delivered to the scalp. The protocol includes brief ramp-up and ramp-down phases at the beginning and end of the session to mimic the sensations of real stimulation, while preventing any meaningful modulation of cortical excitability. This approach, established in previous studies, maintains blinding of participants to the stimulation condition. The investigator administering the stimulation will also be blinded, as the tDCS device allows double blinding, with identical screen displays in both sham and active conditions. Receives: Device: sham tDCS 8 channels |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Functional Connectivity in the Alpha Band (dwPLI)
EEG functional connectivity will be assessed using the debiased weighted Phase Lag Index (dwPLI) in the alpha frequency band (8-12 Hz). This metric quantifies the consistency of phase relationships between EEG signals across brain regions while minimizing the effects of volume conduction. It will be used to evaluate changes in large-scale brain network connectivity associated with cerebellar transcranial direct current stimulation (tDCS) in patients with persistent post-concussion symptoms (PPCS). Differences in connectivity patterns between pre- and post-stimulation recordings, as well as between active and sham groups, will be analyzed.
Measured: EEG functional connectivity will be assessed at two time points: immediately before and immediately after the stimulation session.
Secondary outcomes (12)
Signal entropy and complexity
Signal entropy and complexity refer to quantitative measures of the irregularity, unpredictability, and informational richness of EEG brain activity. These metrics capture the degree of order versus randomness in neural signals and are used to assess changes in brain dynamics induced by the intervention.
Measured: Immediately before and immediately after the stimulation session
EEG microstate
EEG microstate analysis will be conducted to examine temporal dynamics of large-scale brain networks. Metrics will include microstate duration, coverage, and occurrence. These will be computed from resting-state EEG recordings acquired before and after stimulation to explore modulation of brain network organization.
Measured: Immediately before and immediately after the stimulation session
EEG spectral analysis (alpha peak and spectral slope)
Spectral properties of EEG signals will be analyzed, including alpha peak frequency and spectral slope. These measures provide insight into oscillatory activity and excitation-inhibition balance. Analyses will be performed on resting-state EEG recordings collected pre- and post-intervention.
Measured: Immediately before and immediately after the stimulation session
Phase-amplitude coupling
Analyses will assess phase-amplitude coupling and coherence to evaluate cross-frequency interactions and synchronization between brain regions. These measures will be derived from resting-state EEG recordings before and after stimulation.
Measured: Immediately before and immediately after the stimulation session
Alpha band participation coefficient
The participation coefficient in the alpha band will be computed to assess the integration of brain regions within large-scale networks. This will be derived from resting-state EEG data collected pre- and post-intervention.
Measured: Immediately before and immediately after the stimulation session
Rivermead Post-Concussion Symptoms Questionnaire
Post-concussion symptoms will be assessed using the French version of the Rivermead questionnaire. This self-reported measure evaluates the severity of common post-concussion symptoms and will be used to characterize baseline symptom burden.
Measured: Pre-intervention (baseline)
Simple Reaction Time Task
Participants will complete a computerized simple reaction time task to assess processing speed and motor responsiveness. Performance will be compared before and after stimulation.
Measured: Pre-intervention and immediately post-intervention
SCAT6 symptom evaluation
The SCAT6 symptom evaluation (Step 2) will be used to assess immediate concussion-related symptoms. This questionnaire will be administered before and after the intervention to explore changes in symptom severity.
Measured: Pre-intervention and immediately post-intervention
Sustained Attention Task (TAP)
A computerized cognitive task assessing attention will be administered pre- and post-intervention. Performance metrics will be analyzed to evaluate potential cognitive effects of the stimulation.
Measured: Pre-intervention and immediately post-intervention
Blinding assessment
A blinding questionnaire will be completed by both the participant and the interventionist to assess the effectiveness of blinding between active and sham stimulation conditions.
Measured: Immediately post-intervention
Adverse events reporting
Adverse events will be assessed using a standardized questionnaire as described in Reckow et al. This will capture any discomfort or side effects associated with the intervention.
Measured: Immediately post-intervention
Sociodemographic characteristics and medical history
Sociodemographic data will be collected to characterize the study population, including age, gender, level of education, employment status, physical activity level, and substance use (alcohol, tobacco, and drugs). Participants' medical history and current medication use will be recorded to characterize baseline health status and control for potential confounding factors in analyses.
Measured: Pre-intervention (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Persistent Post-concussion 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Nicolas LEJEUNE, University of Liege
- Investigators
- Nicolas Lejeune, Principal investigator, University of Liege - CHU LiegeGéraldine Martens, Study chair, University of LiegeFanny Montulet, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895797
- Sponsor's protocol ID
- Stim-PPCS : 2026-183
- Acronym
- Stim-PPCS
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to qualified researchers whose requests are methodologically sound and for legitimate scientific purposes, following publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of EEG Biomarkers Associated With Transcranial Direct Current Stimulation in Patients With Persistent Post-Concussion Symptoms
- ClinicalTrials.gov ID
- NCT07895797
- Acronym / sponsor ID
- Stim-PPCS / Stim-PPCS : 2026-183
- Keywords
- electroencephalography, persistent post-concussion symptoms, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
In this randomized, sham-controlled, two-group, parallel, single-session study, the investigators aim to identify EEG biomarkers associated with cerebellar transcranial direct current stimulation (tDCS) in patients with persistent post-concussion symptoms (PPCS). Cerebellar tDCS will be used to modulate brain network connectivity, which is known to be altered in PPCS. The study will include 38 participants, each completing a single session including EEG recordings before and after stimulation. Participants will be randomly assigned to one of two conditions: 1) active cerebellar tDCS, or 2) sham stimulation.By focusing on EEG functional connectivity and related signal metrics, this study aims to better understand the neural mechanisms of cerebellar tDCS and support the development of targeted interventions for patients with PPCS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCS 8 channelsActive tDCS participants will receive high-definition cerebellar transcranial direct current stimulation using a multi-electrode montage optimized to target bilateral cerebellar regions. The electrode configuration is identical across conditions and has been defined using computational modeling to maximize focality while limiting current spread to adjacent areas. The stimulation consists of a 30-second ramp-up phase, followed by 20 minutes of continuous stimulation, and a 30-second ramp-down phase. |
| Sham tDCS | Sham comparator | Device: sham tDCS 8 channelsSham tDCS participants will undergo the same high-definition cerebellar electrode montage as the active tDCS group, ensuring identical setup and participant experience. However, no sustained current is delivered to the scalp. The protocol includes brief ramp-up and ramp-down phases at the beginning and end of the session to mimic the sensations of real stimulation, while preventing any meaningful modulation of cortical excitability. This approach, established in previous studies, maintains blinding of participants to the stimulation condition. The investigator administering the stimulation will also be blinded, as the tDCS device allows double blinding, with identical screen displays in both sham and active conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be aged 18 years or older;
- Have received a medical diagnosis of concussion within the 12 months prior to recruitment;
- Exhibit persistent post-concussion symptoms (PPCS) with a score ≥16 on the Rivermead Post-Concussion Symptoms Questionnaire
Key exclusion criteria (3 listed)
- Identified risk for tDCS exposure according to the Transcranial Direct Current Stimulation Safety Screening Tool
- Neurological or psychiatric disorders with a prior medical diagnosis that could alter brain network connectivity before the concussion
- Use of medications (antidepressants, anxiolytics, antipsychotics, antiepileptics) that may affect brain connectivity.
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 |
|---|---|---|
| tDCS 8 channelsTranscranial direct current stimulation is a non-invasive brain stimulation technique that delivers a weak direct electrical current through scalp electrodes to modulate neuronal excitability (<2mA). Cerebellar tDCS will be administered using an 8-channel montage optimized with the Stimweaver software (Neuroelectrics, Barcelona, Spain) to maximize current density over the cerebellum while minimizing off-target effects. A constant direct current will be applied for 20 minutes, with a 30-second ramp-up at the beginning and a 30-second ramp-down at the end. Other Name: | Device | Active tDCS |
| sham tDCS 8 channelsTranscranial direct current stimulation is a non-invasive brain stimulation technique that delivers a weak direct electrical current through scalp electrodes to modulate neuronal excitability (<2 mA). The device used has a sham setting that allows sham stimulation to be delivered while the interventionist remains blinded.Other Name: | Device | Sham tDCS |
Primary outcome
EEG Functional Connectivity in the Alpha Band (dwPLI)
Time frame: EEG functional connectivity will be assessed at two time points: immediately before and immediately after the stimulation session.
EEG functional connectivity will be assessed using the debiased weighted Phase Lag Index (dwPLI) in the alpha frequency band (8-12 Hz). This metric quantifies the consistency of phase relationships between EEG signals across brain regions while minimizing the effects of volume conduction. It will be used to evaluate changes in large-scale brain network connectivity associated with cerebellar transcranial direct current stimulation (tDCS) in patients with persistent post-concussion symptoms (PPCS). Differences in connectivity patterns between pre- and post-stimulation recordings, as well as between active and sham groups, will be analyzed.
12 secondary outcomes
Signal entropy and complexity
Time frame: Immediately before and immediately after the stimulation session
EEG microstate
Time frame: Immediately before and immediately after the stimulation session
EEG spectral analysis (alpha peak and spectral slope)
Time frame: Immediately before and immediately after the stimulation session
Phase-amplitude coupling
Time frame: Immediately before and immediately after the stimulation session
Alpha band participation coefficient
Time frame: Immediately before and immediately after the stimulation session
Rivermead Post-Concussion Symptoms Questionnaire
Time frame: Pre-intervention (baseline)
Simple Reaction Time Task
Time frame: Pre-intervention and immediately post-intervention
SCAT6 symptom evaluation
Time frame: Pre-intervention and immediately post-intervention
Sustained Attention Task (TAP)
Time frame: Pre-intervention and immediately post-intervention
Blinding assessment
Time frame: Immediately post-intervention
Adverse events reporting
Time frame: Immediately post-intervention
Sociodemographic characteristics and medical history
Time frame: Pre-intervention (baseline)
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available to qualified researchers whose requests are methodologically sound and for legitimate scientific purposes, following publication of the primary study results.
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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.
Nicolas Lejeune principal investigator
University of Liege - CHU Liege
Géraldine Martens study chair
University of Liege
Fanny Montulet study director
University of Liege
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 8 channels in people with Patients With Persistent Post-concussion 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 3 inclusion and 3 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 26 Oct 2026. 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 Nicolas Lejeune (+32043232323, nicolas.lejeune@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Functional Connectivity in the Alpha Band (dwPLI) (time frame: EEG functional connectivity will be assessed at two time points: immediately before and immediately after the stimulation session.). 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 26 Oct 2026.