StrokeMAPPYNCT03223571
Brain Plasticity Mapping Post-stroke
An observational study of Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The investigators believe that the initial cerebral connectivity as well as its evolution immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Motor rehabilitation training
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2017to 27 Jul 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants were recruited at the university hospitals of Montpellier and Nimes, where they were treated for an first-ever supra-tentorial stroke.
Who may be able to join
- over 18 yrs, first-ever supratentorial stroke, motor déficits (fugl-meyer score < 30/66)
Who cannot join
- aphasia
- cognitive troubles
- hemineglect (Bergego scale > 15)
- contra-indications for magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Plasticity in Stroke Patients : Functional and Anatomical Connectivty
The investigators believe that the initial cerebral connectivity as well as its evolution immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be analyzed. Clinical, kinematic and imaging (MRI) data will be compared with 12 healthy controls. Kinematic movement information has been collected within the fMRI. By integrating multi-modal clinical, kinematic and MRI, the study aims to identify biomarkers of recovery to improve patient specific evaluation post-stroke in order to adapt rehabilitation protocols accordingly and to improve functional gain.
Read the detailed description
Most people post-stroke are confronted with important sensorimotor deficits of the upper-limb. The identification of clinical, kinematic and MRI biomarkers seems preliminary to i) understand recovery mechanisms, ii) model recovery, and iii) to optimize and personalize rehabilitation strategies that favors adaptive cerebral plasticity and diminish functional deficits.
MAPPY is a complementary study to the interregional PHRC MARGAUT (Medical Adaptive Rehabilitation Games for Arm Use Therapy, EudraCT/ID RCB 2010-A00596-33, Clinical Trial: NCT01554449). Data will be available for 21 participants post-stroke and 12 healthy controls. It includes 1/ clinical data (clinical patient characteristics, Fugl-Meyer Upper Limb scores, Box and Block Test, Wolf Motor Function test, Motor Activity Log), 2/ kinematic data of an elbow flexion/extension task within the fMRI, and 3/ fMRI data (Diffusion images, T2, FLAIR, perfusion, and vascular imaging, 3DT1, fMRI, fMRI resting-state).
It has already been established that isolated clinical evaluation cannot provide a reliable recovery prognosis, nor allow for precise personalization of rehabilitation protocols. In contrast, it has been demonstrated that kinematic movement characteristics can have an additional value concerning the prognosis and evolution of recovery. Finally, changes in clinical and kinematic characteristics are thought to reflect cerebral reorganization. Its principal processes are well described: extended activations around the lesioned area, activation of secondary motor areas and additional activation of regions in the contralesional hemisphere. However, how these changes are linked to actual behavior remains less clear. In healthy people there seems to be a link between control strategies and kinematic characteristics. In addition, post-stroke, links between movement smoothness and secondary motor area recruitment have been described. Therefore, the longitudinal and multimodal approach applied in this study offers the unique opportunity to study functional connectivity early post-stroke as well as its evolution after 6 weeks of rehabilitation. Functional connectivity will be confronted with changes in anatomical connectivity, kinematic movement characteristics, clinical scores, and the initial and final stroke volume and its penumbra. The investigators aim to characterize cerebral plasticity via cerebral connectivity post-stroke and its evolution over recovery, as well as to identify biomarkers to predict motor recovery immediately post-stroke by integrating clinical, kinematic and MRI data to progress towards a personal modilisation of motor recovery post-stroke.
- Conditions
- Stroke
- Being tested
- Motor rehabilitation training
- Keywords
- stroke, Upper arm, Cerebral plasticity, Functional connectivity, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor rehabilitation trainingOther
Post-stroke participants receive 6 week of rehabilitation training of the paretic upper-limb.
| Study group | Role | What they receive |
|---|---|---|
| Early post-stroke (<2 months) | Participants within 2 months of a first supra-tentorial ischeamic stroke, that show a motor deficit of the upper-limb (Fugl Meyer upper limb score < 30/66), older than 18yrs, without aphasie, cognitive troubles or hemineglect Post-stroke participants receive 6 week of motor rehabilitation training of the paretic upper-limb. Receives: Other: Motor rehabilitation training | |
| Controls | Healthy people with no history of neurological pathologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional connectivity
fMRI based functional connectivity between regions of interest (ROI)(e.g. sensorimotor network) during rest and activity, early after stroke and after 6 weeks of routine rehabilitation. The functional connectivity will be quantified using the CONN toolbox, running under MATLAB (the mathworks) that calculates the correlation in spontaneous low frequency BOLD (blood-oxygen-level dependent) fluctuations between ROI. A correlation was considered significant at p < 0.05, with a two-sided cluster extended FDR (false rate discovery) correction.
Measured: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Secondary outcomes (1)
change in anatomical connectivity
Comparing the anatomical connectivity patterns with functional connectivity patterns. Anatomical connectivity will be quantified with the fractional anisotropy and mean diffusivity that quantify white matter modifications (FMRIB's Diffusion Toolbox).
Measured: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start27 Jul 2017
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LAFFONT, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223571
- Sponsor's protocol ID
- UF9858
- Acronym
- MAPPY
- Status last verified
- Jun 2018
- First submitted
- 28 Jun 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Plasticity in Stroke Patients : Functional and Anatomical Connectivty
- ClinicalTrials.gov ID
- NCT03223571
- Acronym / sponsor ID
- MAPPY / UF9858
- Conditions
- Stroke
- Keywords
- stroke, Upper arm, Cerebral plasticity, Functional connectivity, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 21 Jul 2017 (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.
The investigators believe that the initial cerebral connectivity as well as its evolution immediate post-stroke could be correlated to the amount of motor recovery. Therefore a cohort of 21 people early post-stroke, and 6 weeks post standard routine rehabilitation will be analyzed. Clinical, kinematic and imaging (MRI) data will be compared with 12 healthy controls. Kinematic movement information has been collected within the fMRI. By integrating multi-modal clinical, kinematic and MRI, the study aims to identify biomarkers of recovery to improve patient specific evaluation post-stroke in order to adapt rehabilitation protocols accordingly and to improve functional gain.
Detailed description
Most people post-stroke are confronted with important sensorimotor deficits of the upper-limb. The identification of clinical, kinematic and MRI biomarkers seems preliminary to i) understand recovery mechanisms, ii) model recovery, and iii) to optimize and personalize rehabilitation strategies that favors adaptive cerebral plasticity and diminish functional deficits.
MAPPY is a complementary study to the interregional PHRC MARGAUT (Medical Adaptive Rehabilitation Games for Arm Use Therapy, EudraCT/ID RCB 2010-A00596-33, Clinical Trial: NCT01554449). Data will be available for 21 participants post-stroke and 12 healthy controls. It includes 1/ clinical data (clinical patient characteristics, Fugl-Meyer Upper Limb scores, Box and Block Test, Wolf Motor Function test, Motor Activity Log), 2/ kinematic data of an elbow flexion/extension task within the fMRI, and 3/ fMRI data (Diffusion images, T2, FLAIR, perfusion, and vascular imaging, 3DT1, fMRI, fMRI resting-state).
It has already been established that isolated clinical evaluation cannot provide a reliable recovery prognosis, nor allow for precise personalization of rehabilitation protocols. In contrast, it has been demonstrated that kinematic movement characteristics can have an additional value concerning the prognosis and evolution of recovery. Finally, changes in clinical and kinematic characteristics are thought to reflect cerebral reorganization. Its principal processes are well described: extended activations around the lesioned area, activation of secondary motor areas and additional activation of regions in the contralesional hemisphere. However, how these changes are linked to actual behavior remains less clear. In healthy people there seems to be a link between control strategies and kinematic characteristics. In addition, post-stroke, links between movement smoothness and secondary motor area recruitment have been described. Therefore, the longitudinal and multimodal approach applied in this study offers the unique opportunity to study functional connectivity early post-stroke as well as its evolution after 6 weeks of rehabilitation. Functional connectivity will be confronted with changes in anatomical connectivity, kinematic movement characteristics, clinical scores, and the initial and final stroke volume and its penumbra. The investigators aim to characterize cerebral plasticity via cerebral connectivity post-stroke and its evolution over recovery, as well as to identify biomarkers to predict motor recovery immediately post-stroke by integrating clinical, kinematic and MRI data to progress towards a personal modilisation of motor recovery post-stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early post-stroke (<2 months) | – | Other: Motor rehabilitation trainingParticipants within 2 months of a first supra-tentorial ischeamic stroke, that show a motor deficit of the upper-limb (Fugl Meyer upper limb score < 30/66), older than 18yrs, without aphasie, cognitive troubles or hemineglect Post-stroke participants receive 6 week of motor rehabilitation training of the paretic upper-limb. |
| Controls | – | –Healthy people with no history of neurological pathologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited at the university hospitals of Montpellier and Nimes, where they were treated for an first-ever supra-tentorial stroke.
Key inclusion criteria (1 listed)
- over 18 yrs, first-ever supratentorial stroke, motor déficits (fugl-meyer score < 30/66)
Key exclusion criteria (4 listed)
- aphasia
- cognitive troubles
- hemineglect (Bergego scale > 15)
- contra-indications for magnetic resonance imaging
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 |
|---|---|---|
| Motor rehabilitation trainingPost-stroke participants receive 6 week of rehabilitation training of the paretic upper-limb. | Other | Early post-stroke (<2 months) |
Primary outcome
Change in functional connectivity
Time frame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
fMRI based functional connectivity between regions of interest (ROI)(e.g. sensorimotor network) during rest and activity, early after stroke and after 6 weeks of routine rehabilitation. The functional connectivity will be quantified using the CONN toolbox, running under MATLAB (the mathworks) that calculates the correlation in spontaneous low frequency BOLD (blood-oxygen-level dependent) fluctuations between ROI. A correlation was considered significant at p < 0.05, with a two-sided cluster extended FDR (false rate discovery) correction.
1 secondary outcome
change in anatomical connectivity
Time frame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
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 8 Jun 2018.
- Individual participant dataSharing planned: Undecided. NC
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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
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Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
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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.
Isabelle LAFFONT, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Montpellier 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 1 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: finished, as of the sponsor's last update on 8 Jun 2018. 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?
Change in functional connectivity (time frame: from V0 (<2 months post-stroke) to V1 (V0+6wks).). 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 8 Jun 2018.