Temporal PerturbationNASNCT07468032
Dynamic Causal Modeling of Neuromodulation of Action Speed Via Targeted TMS-EEG
A study testing Phase 1 functional MRI (fMRI), Phase 2 functional MRI (fMRI) and Phase 3 functional MRI (fMRI) in people with Temporal Perturbation and Virtual Lesion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporal Perturbation, Virtual Lesion, EEG
- What is being tested?
- Phase 1 functional MRI (fMRI), Phase 2 functional MRI (fMRI) and Phase 3 functional MRI (fMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, Picardie, 80000
Olivier Godefroy, MD-PhD, ++33322668240, godefroy.olivier@chu-amiens.fr
Etienne Allart, Pr
About this study
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.
- Conditions
- Temporal Perturbation, Virtual Lesion, EEG, fNIRS, TMS, Stroke Lesions
- Being tested
- Phase 1 functional MRI (fMRI), Phase 2 functional MRI (fMRI), Phase 3 functional MRI (fMRI)
- Keywords
- Temporal perturbation, Virtual lesion, EEG, fNIRS, TMS, stroke lesions, action slowing, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 functional MRI (fMRI)Other
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
Phase 2 functional MRI (fMRI)Other
Phase 2 will assess the effects of intermittent theta burst stimulation (iTBS) on improving action speed in healthy individuals.
Phase 3 functional MRI (fMRI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Lesions | Experimental | Healthy participants will undergo TMS-induced perturbations targeting seven key brain regions to evaluate their involvement in modulating action speed. Receives: Other: Phase 1 functional MRI (fMRI) |
| iTBS | Experimental | Healthy participants will receive iTBS to the most relevant brain regions to evaluate its impact on action speed. Receives: Other: Phase 2 functional MRI (fMRI) |
| Individualized iTBS | Experimental | Stroke patients will receive tailored iTBS to enhance action speed, with assessments at multiple time points. Receives: Other: Phase 3 functional MRI (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
variations in action speed is the reaction time
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.
Measured: day 0
Secondary outcomes (1)
variation between both groups of brain connectivity values
changes in brain connectivity values induced by rTMS in healthy controls and post-stroke patients.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start6 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal PerturbationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- CHRU LILLE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468032
- Sponsor's protocol ID
- PI2025_843_0195
- Acronym
- NAS
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Causal Modeling of Neuromodulation of Action Speed Via Targeted TMS-EEG
- ClinicalTrials.gov ID
- NCT07468032
- Acronym / sponsor ID
- NAS / PI2025_843_0195
- Conditions
- Temporal Perturbation, Virtual Lesion, EEG, fNIRS, TMS, Stroke Lesions
- Keywords
- Temporal perturbation, Virtual lesion, EEG, fNIRS, TMS, stroke lesions, action slowing, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- CHRU LILLE
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Lesions | Experimental | Other: Phase 1 functional MRI (fMRI)Healthy participants will undergo TMS-induced perturbations targeting seven key brain regions to evaluate their involvement in modulating action speed. |
| iTBS | Experimental | Other: Phase 2 functional MRI (fMRI)Healthy participants will receive iTBS to the most relevant brain regions to evaluate its impact on action speed. |
| Individualized iTBS | Experimental | Other: Phase 3 functional MRI (fMRI)Stroke patients will receive tailored iTBS to enhance action speed, with assessments at multiple time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 :
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Virtual Lesions |
| Phase 2 functional MRI (fMRI)Phase 2 will assess the effects of intermittent theta burst stimulation (iTBS) on improving action speed in healthy individuals. | Other | iTBS |
| 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. | Other | Individualized iTBS |
Primary outcome
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.
1 secondary outcome
variation between both groups of brain connectivity values
Time frame: day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1 functional MRI (fMRI), Phase 2 functional MRI (fMRI) and Phase 3 functional MRI (fMRI) in people with Temporal Perturbation and Virtual Lesion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GODEFROY Olivier, Pr (33+322668240, Godefroy.Olivier@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variations in action speed is the reaction time (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.