StrokeATTACKNCT03784534
Brain Network Models of Motor Recovery After Stroke
A study testing Imaging, Clinical and behavioral testing : Motor recovery progress and Clinical and behavioral testing : Motor skills in people with Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
As with other real=world connected systems, studying the network structure of multiple interactions in the brain (holism versus reductionism) has profound implications in the comprehension of emergent complex phenomena like, for example, the capability to functionally reorganize after cerebrovascular "attacks" or… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Imaging, Clinical and behavioral testing : Motor recovery progress and Clinical and behavioral testing : Motor skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First ever stroke
- Delay between stroke onset and inclusion=10 days
- Upper limb motor deficit assessed by the Fugl Meyer score
- Written consent given
- French health insurance
- MMSE score > 26 for healthy volunteers
Who cannot join
- Aged 18 to 85 years
- Contra indication for MRI, unwilling to be informed a brain abnormality discovered on MRI other than the known one
- Life threatening condition during the year of follow up
- Surgery of the upper limb that impact the functional abilities
- Pregnancy, people under legal guardian
- Rankin score > 2 before the stroke
- Subjects already involved in a therapeutic trial
- Territorial sequelae old to the imagery
Trial locations and contacts
1 site in 1 country.
France1 site
Urgences cérébro-vasculaires, Hôpital Pitié-Salpêtrière
Paris, 75013
About this study
As with other real=world connected systems, studying the network structure of multiple interactions in the brain (holism versus reductionism) has profound implications in the comprehension of emergent complex phenomena like, for example, the capability to functionally reorganize after cerebrovascular "attacks" or stroke. This dynamic skill, which is known in neuroscience as brain plasticity, is not only interesting from a network perspective, but it also plays a crucial role in determining the motor/cognitive recovery of patients who survive a stroke.
Network analysis of functional connectivity (FC) patterns estimated from neuroimaging techniques such as electroencephalography (EEG), magnetoencephalography (MEG) and functional magnetic resonance imaging (fMRI) has allowed a major breakthrough in the understanding of physiopathology of stroke from a system perspective. Recent evidence from cross=sectional studies1,2 highlights that stroke lesions generally induce i) critical deviation from optimal (i.e. small=world) network topologies supporting both segregated and integrated information processing, ii) altered inter=hemispheric connectivity and modularity, iii) and abnormal region centrality in the ipsilesional hemisphere as well as in the contralesional hemisphere. While these findings provide new descriptors on how stroke lesions affect the functional brain network organization and how this correlates with the resulting behavioral impairment (e.g. hemiplegia, aphasia), they only represent a static picture of the brain plasticity, which is instead intrinsically dynamic, and partially inform on the chances of single patients to recover their motor/cognitive functions. These aspects dramatically limit the investigator's ability to fully understand the brain organizational mechanisms after stroke and to probe the predictive power of possible network=based neuromarkers of recovery. The ATTACK project aims to overcome these technological and methodological barriers by implementing the following three=fold strategy:
- acquiring a longitudinal dataset of brain and behavioral data in stroke patients and healthy controls,
- developing new analytic tools to characterize and generate temporally dynamic brain networks,
- building network=based models of functional recovery after stroke, accounting for individual patients.
Read the detailed description
The major thrust of this project is to develop a fundamentally new technology that overpasses current views in brain network analysis in an effort to i) identify the organizational mechanisms of brain plasticity underlying recovery in stroke patients and ii) exploit this information to design new diagnostic and prognostic neuromarkers of motor recovery.
ATTACK focuses on the acquisition of a longitudinal dataset (15 patients and 15 age=matched healthy controls). Multimodal data (clinical/functional scales, behavioral measures, brain activity EEG) will be collected from each patient at different phases after stroke across a series of consecutive recording sessions, i.e. +10 days, +1 month, +3 months, +6 months, +12 months after the first stroke event
Patients will be selected with the following inclusion criteria: first=ever infarct lesion, with hand motor impairment. Exclusion criteria will be aged 18 to 85 years, inability to understand the task or perform motor tasks, contraindication to MRI. In each session, patients will be asked to perform several trials of resting state and hand grasping tasks (imagery and execution) in order to study also the intra=session brain changes occurring at short=time scales. Differently from current approaches focusing on fMRI changes, the present project focuses on high= density (64 sensors) EEG data in order to exploit the higher temporal resolution (in the order of ms) and have a much clearer understanding of the motor processes occurring at rapid oscillatory ranges (e.g. ERD/ERS). Furthermore, the high portability of EEG systems has the advantage to perform recording sessions at the patient's bedside, or even at home, in a totally non=invasive way, thus decreasing the impact on patient life in the hospital.
Clinical and behavioral data will be also collected from each patient to assess their motor recovery progress. Different scores include the ARAT, hand grip strength, NIHSS with motor subitems and Rankin score. Finally, anatomical MRI (T1 and tensor imaging) scan will be acquired for each patient after the subacute phase (+3 months) in order to locate and assess the severity/size of the lesion. These scores and data will be eventually used as covariates for the brain network topological changes. The first recording session will be performed at the Stroke unit of the Hospital Pitié_Salpêtrière. Subsequent sessions will be performed at the ICM, operated by the Centre EEG/MEG (CENIR).
The same data will be also collected at the ICM from the group of age-matched healthy subjects according to the same protocols and timing. This data are crucial in that they will be used to assess the statistical significance of the changes observed in the stroke patients. Recording sessions will be conducted in compliance with French regulations, including provisions relating to biomedical research in the Public Health Code, the French Bioethics law, the French Data Protection Act, and the World Medical Association Declaration of Helsinki.
- Conditions
- Stroke
- Being tested
- Imaging, Clinical and behavioral testing : Motor recovery progress, Clinical and behavioral testing : Motor skills
- Keywords
- EEG, Recovery, Motor
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingOther
high= density (64 sensors) EEG and anatomical MRI (T1 and tensor imaging) scan
Clinical and behavioral testing : Motor recovery progressBehavioural
NIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, test of Ashworth
Clinical and behavioral testing : Motor skillsBehavioural
the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Subjects will be asked to perform:
* high= density (64 sensors) EEG
* clinical and behavioral data will be also collected from each subject to evaluate their motor skills: the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer
* anatomical MRI (T1 and tensor imaging) scan) Receives: Other: Imaging; Behavioral: Clinical and behavioral testing : Motor skills |
| Patients | Experimental | Patients will be asked to perform:
* high= density (64 sensors) EEG
* clinical and behavioral data will be also collected from each patient to assess their motor recovery progress: the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, NIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, Fugl Meyer, test of Ashworth
* anatomical MRI (T1 and tensor imaging) scan) Receives: Other: Imaging; Behavioral: Clinical and behavioral testing : Motor recovery progress; Behavioral: Clinical and behavioral testing : Motor skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)
EEG centrality in M1 (arbitrary unit: [0-1])
Measured: 1 year
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)
onnectivity indice: density of connectivity between cerebral hemispheres (arbitrary unit: [0-1])
Measured: 1 year
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)
connectivity indice: network efficiency determined by areas topological distance (arbitrary unit: [0-1])
Measured: 1 year
Secondary outcomes (3)
Describe the changes in EEG connectivity during motor recovery
EEG centrality in M1 (arbitrary unit: [0-1]
Measured: 1 year
Describe the changes in EEG connectivity during motor recovery
connectivity indice: density of connectivity between cerebral hemispheres (arbitrary unit: [0-1])
Measured: 1 year
Describe the changes in EEG connectivity during motor recovery
connectivity indice: network efficiency determined by areas topological distance (arbitrary unit: [0-1])
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start4 Sep 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Model description
- Pathophysiological and longitudinal study with no therapeutic intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784534
- Sponsor's protocol ID
- C17-75
- Other IDs
- 2018-A02765-50
- Acronym
- ATTACK
- Status last verified
- Mar 2025
- First submitted
- 10 Dec 2018
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Models of Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03784534
- Acronym / sponsor ID
- ATTACK / C17-75
- Conditions
- Stroke
- Keywords
- EEG, Recovery, Motor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 24 Dec 2018 (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.
As with other real=world connected systems, studying the network structure of multiple interactions in the brain (holism versus reductionism) has profound implications in the comprehension of emergent complex phenomena like, for example, the capability to functionally reorganize after cerebrovascular "attacks" or stroke. This dynamic skill, which is known in neuroscience as brain plasticity, is not only interesting from a network perspective, but it also plays a crucial role in determining the motor/cognitive recovery of patients who survive a stroke.
Network analysis of functional connectivity (FC) patterns estimated from neuroimaging techniques such as electroencephalography (EEG), magnetoencephalography (MEG) and functional magnetic resonance imaging (fMRI) has allowed a major breakthrough in the understanding of physiopathology of stroke from a system perspective. Recent evidence from cross=sectional studies1,2 highlights that stroke lesions generally induce i) critical deviation from optimal (i.e. small=world) network topologies supporting both segregated and integrated information processing, ii) altered inter=hemispheric connectivity and modularity, iii) and abnormal region centrality in the ipsilesional hemisphere as well as in the contralesional hemisphere. While these findings provide new descriptors on how stroke lesions affect the functional brain network organization and how this correlates with the resulting behavioral impairment (e.g. hemiplegia, aphasia), they only represent a static picture of the brain plasticity, which is instead intrinsically dynamic, and partially inform on the chances of single patients to recover their motor/cognitive functions. These aspects dramatically limit the investigator's ability to fully understand the brain organizational mechanisms after stroke and to probe the predictive power of possible network=based neuromarkers of recovery. The ATTACK project aims to overcome these technological and methodological barriers by implementing the following three=fold strategy:
- acquiring a longitudinal dataset of brain and behavioral data in stroke patients and healthy controls,
- developing new analytic tools to characterize and generate temporally dynamic brain networks,
- building network=based models of functional recovery after stroke, accounting for individual patients.
Detailed description
The major thrust of this project is to develop a fundamentally new technology that overpasses current views in brain network analysis in an effort to i) identify the organizational mechanisms of brain plasticity underlying recovery in stroke patients and ii) exploit this information to design new diagnostic and prognostic neuromarkers of motor recovery.
ATTACK focuses on the acquisition of a longitudinal dataset (15 patients and 15 age=matched healthy controls). Multimodal data (clinical/functional scales, behavioral measures, brain activity EEG) will be collected from each patient at different phases after stroke across a series of consecutive recording sessions, i.e. +10 days, +1 month, +3 months, +6 months, +12 months after the first stroke event
Patients will be selected with the following inclusion criteria: first=ever infarct lesion, with hand motor impairment. Exclusion criteria will be aged 18 to 85 years, inability to understand the task or perform motor tasks, contraindication to MRI. In each session, patients will be asked to perform several trials of resting state and hand grasping tasks (imagery and execution) in order to study also the intra=session brain changes occurring at short=time scales. Differently from current approaches focusing on fMRI changes, the present project focuses on high= density (64 sensors) EEG data in order to exploit the higher temporal resolution (in the order of ms) and have a much clearer understanding of the motor processes occurring at rapid oscillatory ranges (e.g. ERD/ERS). Furthermore, the high portability of EEG systems has the advantage to perform recording sessions at the patient's bedside, or even at home, in a totally non=invasive way, thus decreasing the impact on patient life in the hospital.
Clinical and behavioral data will be also collected from each patient to assess their motor recovery progress. Different scores include the ARAT, hand grip strength, NIHSS with motor subitems and Rankin score. Finally, anatomical MRI (T1 and tensor imaging) scan will be acquired for each patient after the subacute phase (+3 months) in order to locate and assess the severity/size of the lesion. These scores and data will be eventually used as covariates for the brain network topological changes. The first recording session will be performed at the Stroke unit of the Hospital Pitié_Salpêtrière. Subsequent sessions will be performed at the ICM, operated by the Centre EEG/MEG (CENIR).
The same data will be also collected at the ICM from the group of age-matched healthy subjects according to the same protocols and timing. This data are crucial in that they will be used to assess the statistical significance of the changes observed in the stroke patients. Recording sessions will be conducted in compliance with French regulations, including provisions relating to biomedical research in the Public Health Code, the French Bioethics law, the French Data Protection Act, and the World Medical Association Declaration of Helsinki.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pathophysiological and longitudinal study with no therapeutic intervention
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Imaging, Behavioral: Clinical and behavioral testing : Motor skillsSubjects will be asked to perform: * high= density (64 sensors) EEG * clinical and behavioral data will be also collected from each subject to evaluate their motor skills: the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer * anatomical MRI (T1 and tensor imaging) scan) |
| Patients | Experimental | Other: Imaging, Behavioral: Clinical and behavioral testing : Motor recovery progress, Behavioral: Clinical and behavioral testing : Motor skillsPatients will be asked to perform: * high= density (64 sensors) EEG * clinical and behavioral data will be also collected from each patient to assess their motor recovery progress: the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, NIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, Fugl Meyer, test of Ashworth * anatomical MRI (T1 and tensor imaging) scan) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First ever stroke
- Delay between stroke onset and inclusion=10 days
- Upper limb motor deficit assessed by the Fugl Meyer score
- Written consent given
- French health insurance
Key exclusion criteria (8 listed)
- Aged 18 to 85 years
- Contra indication for MRI, unwilling to be informed a brain abnormality discovered on MRI other than the known one
- Life threatening condition during the year of follow up
- Surgery of the upper limb that impact the functional abilities
- Pregnancy, people under legal guardian
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 |
|---|---|---|
| Imaginghigh= density (64 sensors) EEG and anatomical MRI (T1 and tensor imaging) scan | Other | Healthy volunteers, Patients |
| Clinical and behavioral testing : Motor recovery progressNIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, test of Ashworth | Behavioural | Patients |
| Clinical and behavioral testing : Motor skillsthe ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer | Behavioural | Healthy volunteers, Patients |
Primary outcome
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)
Time frame: 1 year
EEG centrality in M1 (arbitrary unit: [0-1])
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)
Time frame: 1 year
onnectivity indice: density of connectivity between cerebral hemispheres (arbitrary unit: [0-1])
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)
Time frame: 1 year
connectivity indice: network efficiency determined by areas topological distance (arbitrary unit: [0-1])
3 secondary outcomes
Describe the changes in EEG connectivity during motor recovery
Time frame: 1 year
Describe the changes in EEG connectivity during motor recovery
Time frame: 1 year
Describe the changes in EEG connectivity during motor recovery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging, Clinical and behavioral testing : Motor recovery progress and Clinical and behavioral testing : Motor skills in people with Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 28 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year) (time frame: 1 year). The study lists 3 primary outcomes in all. 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 28 Mar 2025.