Trial · NCT07895797
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | EEG Functional Connectivity in the Alpha Band (dwPLI) | 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. |
| Secondary | Permutation entropy (PE) | Immediately before and immediately after the stimulation session | Permutation Entropy (PE) will be calculated from EEG signals to quantify the temporal irregularity and unpredictability of brain activity. PE is a dimensionless measure. |
| Secondary | Normalized Lempel-Ziv Complexity (LZC) | Immediately before and immediately after the stimulation session | 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. |
| Secondary | EEG microstate | Immediately before and immediately after the stimulation session | 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. |
| Secondary | EEG spectral analysis (alpha peak and spectral slope) | Immediately before and immediately after the stimulation session | 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. |
| Secondary | Phase-amplitude coupling | Immediately before and immediately after the stimulation session | 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. |
| Secondary | Alpha band participation coefficient | Immediately before and immediately after the stimulation session | 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. |
| Secondary | Rivermead Post-Concussion Symptoms Questionnaire | Pre-intervention (baseline) | 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. |
| Secondary | Simple Reaction Time Task | Pre-intervention and immediately post-intervention | Participants will complete a computerized simple reaction time task to assess processing speed and motor responsiveness. Performance will be compared before and after stimulation. |
| Secondary | Sport concussion assessment tool 6 (SCAT6) | Pre-intervention and immediately post-intervention | 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. |
| Secondary | Sustained Attention Task (TAP) | Pre-intervention and immediately post-intervention | 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. |
| Secondary | Blinding assessment | Immediately post-intervention | 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. |
| Secondary | Adverse events reporting | Immediately post-intervention | 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. |
| Secondary | Sociodemographic characteristics and medical history | Pre-intervention (baseline) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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