NCT07468032 Dynamic Causal Modeling of Neuromodulation of Action Speed Via Targeted TMS-EEG
| NCT ID | NCT07468032 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Temporal Perturbation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-01-06 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke is a major cause of long-term disability, with cognitive and motor deficits-especially action slowing and executive dysfunction-being strong predictors of poor recovery outcomes. Recent advances in network neuroscience suggest that action speed is governed by interactions between specific prefrontal and premotor regions. However, the precise neural mechanisms underlying action slowing in stroke remain unclear, limiting the efficacy of current rehabilitation approaches. This study integrates high-density EEG, fNIRS and dynamic causal modeling (DCM), and rTMS to map and modulate the neural circuits involved in action speed. In the first phase, we will assess the role of seven key brain regions in action speed modulation by applying virtual lesions using single-pulse TMS in 60 healthy individuals. In the second phase, we will apply offline intermittent theta burst stimulation (iTBS) to the most relevant regions and evaluate its impact on action speed. Finally, in the clinical phase, we will administer individualized iTBS to 20 stroke patients to enhance action speed. Patients will be assessed at baseline, immediately post-treatment, and after one and three months to track improvements in action speed using DCM and behavioral tests. Changes in connectivity and action speed performance will be compared to healthy controls to refine treatment parameters. Secondary outcomes include executive function and daily life motor performance. Longitudinal follow-up will determine the persistence of improvements, informing future personalized rehabilitation strategies. By characterizing effective connectivity changes post-stroke, we aim to refine neuromodulation strategies and develop a personalized rTMS approach. Our hypothesis is that targeting specific regions identified through integration of EEG, fNIRS and DCM can enhance action speed, ultimately improving functional recovery. This personalized approach could lead to more effective rehabilitation protocols, tailored to individual brain damage patterns.
Eligibility Criteria
Inclusion Criteria: * The control group consists of individuals who are : * neurologically healthy, * meaning they do not have any medical conditions that could interfere with cognitive performance or its measurement. * not have any contraindications for undergoing MRI scans or TMS, such as epilepsy, which could be triggered by magnetic stimulation. * The patient group will include : * individuals who have experienced a hemispheric stroke but with specific criteria ( stroke must not have affected key prefrontal regions that are targeted in the study, ensuring that the observed motor slowing is due to network dysfunction rather than direct structural damage to these regions) * be free of other cognitive impairments or medical conditions that could confound the study's results. Exclusion Criteria: * participants with neurological, * psychiatric, or general conditions known to alter test performance or cognitive function, according to a previously validated method will be excluded. * any contraindication to MRI and TMS (e.g., epilepsy). * For stroke patients, the lesion delineated on MRI must spare the prefrontal target structures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07468032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Temporal Perturbation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07468032 currently recruiting?
Yes, NCT07468032 is actively recruiting participants. Contact the research team at Godefroy.Olivier@chu-amiens.fr for enrollment information.
Where is the NCT07468032 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT07468032 clinical trial?
NCT07468032 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 80 participants.