Dynamic Causal Modeling of Neuromodulation of Action Speed Via Targeted TMS-EEG (NAS)

March 10, 2026 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80000
        • Recruiting
        • CHU Amiens
        • Contact:
        • Principal Investigator:
          • Etienne Allart, Pr
        • Sub-Investigator:
          • Ardalan Aarabi, Pr
        • Sub-Investigator:
          • Hervé Devanne, Pr
        • Sub-Investigator:
          • Pierre Morel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Lesions
Healthy participants will undergo TMS-induced perturbations targeting seven key brain regions to evaluate their involvement in modulating action speed.
Other: Phase 1 functional MRI (fMRI)

3D T1-weighted imaging (T1w) and (10 min) resting-state functional MRI (fMRI) will be acquired for each healthy subject to identify target regions for TMS interventions.

Phase 1 aims to assess the impact of temporary disruption (caused by virtual lesions (VL)) on action speed, measured by reaction time (RT) using a simple reaction time (SRT) task in healthy subjects
Experimental: iTBS
Healthy participants will receive iTBS to the most relevant brain regions to evaluate its impact on action speed.
Other: Phase 2 functional MRI (fMRI)
Phase 2 will assess the effects of intermittent theta burst stimulation (iTBS) on improving action speed in healthy individuals.
Experimental: Individualized iTBS
Stroke patients will receive tailored iTBS to enhance action speed, with assessments at multiple time points.
Other: Phase 3 functional MRI (fMRI)
Phase 3 administers iTBS to enhance action speed in stroke patients within the first six months post-stroke, leveraging individualized action speed models to tailor interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variations in action speed is the reaction time
Time Frame: day 0
variations in action speed is the reaction time measured during a simple reaction time task, in which participants respond as quickly as possible to a visual stimulus using the index finger of their preferred hand.
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation between both groups of brain connectivity values
Time Frame: day 0
changes in brain connectivity values induced by rTMS in healthy controls and post-stroke patients.
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

CHRU LILLE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2025_843_0195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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