Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07468032
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Causal Modeling of Neuromodulation of Action Speed Via Targeted TMS-EEG
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Dynamic Causal Modeling of Neuromodulation of Action Speed Via Targeted TMS-EEG
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAS
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: