- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07895797
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients (Stim-PPCS)
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nicolas Lejeune
- Numer telefonu: +32043232323
- E-mail: nicolas.lejeune@uliege.be
Lokalizacje studiów
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Liege
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Tinlot, Liege, Belgia, 4557
- Centre Neurologique et de réadaptation Fonctionnelle
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Kontakt:
- Lejeune Nicolas
- Numer telefonu: +32043232323
- E-mail: nicolas.lejeune@uliege.be
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Active tDCS
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. |
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: |
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Pozorny komparator: Sham tDCS
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. |
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: |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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EEG Functional Connectivity in the Alpha Band (dwPLI)
Ramy czasowe: EEG functional connectivity will be assessed at two time points: immediately before and immediately after the stimulation session.
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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. |
EEG functional connectivity will be assessed at two time points: immediately before and immediately after the stimulation session.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Permutation entropy (PE)
Ramy czasowe: Immediately before and immediately after the stimulation session
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Permutation Entropy (PE) will be calculated from EEG signals to quantify the temporal irregularity and unpredictability of brain activity. PE is a dimensionless measure. |
Immediately before and immediately after the stimulation session
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Normalized Lempel-Ziv Complexity (LZC)
Ramy czasowe: Immediately before and immediately after the stimulation session
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Normalized Lempel-Ziv Complexity (LZC) will be calculated from EEG signals to quantify the diversity and complexity of brain activity patterns. LZC is a dimensionless measure. |
Immediately before and immediately after the stimulation session
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EEG microstate
Ramy czasowe: Immediately before and immediately after the stimulation session
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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. |
Immediately before and immediately after the stimulation session
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EEG spectral analysis (alpha peak and spectral slope)
Ramy czasowe: Immediately before and immediately after the stimulation session
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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. |
Immediately before and immediately after the stimulation session
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Phase-amplitude coupling
Ramy czasowe: Immediately before and immediately after the stimulation session
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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. |
Immediately before and immediately after the stimulation session
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Alpha band participation coefficient
Ramy czasowe: Immediately before and immediately after the stimulation session
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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. |
Immediately before and immediately after the stimulation session
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Rivermead Post-Concussion Symptoms Questionnaire
Ramy czasowe: Pre-intervention (baseline)
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Post-concussion symptoms will be assessed using the French version of the Rivermead Post-Concussion Symptoms Questionnaire (total score range: 0-64, with higher scores indicating greater symptom severity). This self-reported measure evaluates the severity of common post-concussion symptoms and will be used to characterize baseline symptom burden. |
Pre-intervention (baseline)
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Simple Reaction Time Task
Ramy czasowe: Pre-intervention and immediately post-intervention
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Participants will complete a computerized simple reaction time task to assess processing speed and motor responsiveness. Performance will be compared before and after stimulation. |
Pre-intervention and immediately post-intervention
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Sport concussion assessment tool 6 (SCAT6)
Ramy czasowe: Pre-intervention and immediately post-intervention
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The SCAT6 symptom evaluation (Step 2) will be used to assess immediate concussion-related symptoms (total score range: 0-132, with higher scores indicating greater symptom severity). This questionnaire will be administered before and after the intervention to explore changes in symptom severity. |
Pre-intervention and immediately post-intervention
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Sustained Attention Task (TAP)
Ramy czasowe: Pre-intervention and immediately post-intervention
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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. |
Pre-intervention and immediately post-intervention
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Blinding assessment
Ramy czasowe: Immediately post-intervention
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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. |
Immediately post-intervention
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Adverse events reporting
Ramy czasowe: Immediately post-intervention
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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. |
Immediately post-intervention
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Sociodemographic characteristics and medical history
Ramy czasowe: Pre-intervention (baseline)
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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. |
Pre-intervention (baseline)
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Nicolas Lejeune, University of Liege - CHU Liege
- Krzesło do nauki: Géraldine Martens, University of Liege
- Dyrektor Studium: Fanny Montulet, University of Liege
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Stim-PPCS : 2026-183
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
IPD and supporting information will be made available after publication of the primary study results upon reasonable request and subject to approval. Data will be stored in Dataverse ULiège under restricted access for an indefinite period.
Kryteria dostępu do udostępniania IPD
Access to the anonymized individual participant data (IPD) and supporting information, including the study protocol, data dictionary, and statistical analysis code, will be granted to qualified researchers upon reasonable request.
Requests will be evaluated by the principal investigator based on scientific validity, methodological quality, and compliance with the original ethical approval and informed consent.
Approved users will receive access through a secure institutional repository (e.g., ULiège Dataverse)
Only de-identified data will be shared.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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