Brain Plasticity Mapping Post-stroke (MAPPY)

June 7, 2018 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

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.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.
Other: Motor rehabilitation training
Post-stroke participants receive 6 week of rehabilitation training of the paretic upper-limb.
Controls
Healthy people with no history of neurological pathologies

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
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.
from V0 (<2 months post-stroke) to V1 (V0+6wks).

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
change in anatomical connectivity
Time Frame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
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).
from V0 (<2 months post-stroke) to V1 (V0+6wks).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in kinematic scores
Time Frame: from V0 (<2 months post-stroke) to V1 (V0+6wks)
Analysis of the correlation between functional connectivity outcomes and kinematic characteristics that are calculated on the 3D displacement of the hand in space during a flexion and extension of the elbow in the vertical plane within the fMRI. Calculated kinematics include the frequency, the amplitude, the smoothness and the directness of the movement.
from V0 (<2 months post-stroke) to V1 (V0+6wks)
change in Fugl-Meyer upper-limb assessement score
Time Frame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Correlation analysis of the functional connectivity outcomes with the clinical performance scores.
from V0 (<2 months post-stroke) to V1 (V0+6wks).
change in Lesion characteristics.
Time Frame: from V0 (<2 months post-stroke) to V1 (V0+6wks).
Analysis of possible correlation between the initial lesion volume with functional connectivity patterns.
from V0 (<2 months post-stroke) to V1 (V0+6wks).

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.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabelle LAFFONT, MD, PhD, University Hospital, Montpellier

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.
July 27, 2017

Primary Completion (Actual)

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.
July 27, 2017

Study Completion (Actual)

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.
July 27, 2017

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).
June 28, 2017

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.
July 19, 2017

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.
July 21, 2017

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.
June 8, 2018

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.
June 7, 2018

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.
June 1, 2018

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.
  • UF9858

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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