Clinical trial NCT03223571: Brain Plasticity Mapping Post-stroke
Official title: Brain Plasticity in Stroke Patients : Functional and Anatomical Connectivty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
Upper arm
Cerebral plasticity
Functional connectivity
Rehabilitation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited at the university hospitals of Montpellier and Nimes, where they were treated for an first-ever supra-tentorial stroke.

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

- over 18 yrs, first-ever supratentorial stroke, motor déficits (fugl-meyer score \< 30/66)

Exclusion criteria:

* aphasia
* cognitive troubles
* hemineglect (Bergego scale \> 15)
* contra-indications for magnetic resonance imaging

Primary outcomes:
measure: Change in functional connectivity
timeFrame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Secondary outcomes:
measure: change in anatomical connectivity
timeFrame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Other outcomes:
measure: change in kinematic scores
timeFrame: from V0 (<2 months post-stroke) to V1 (V0+6wks)
measure: change in Fugl-Meyer upper-limb assessement score
timeFrame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
measure: change in Lesion characteristics.
timeFrame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Isabelle LAFFONT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: