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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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