Brain Plasticity Mapping Post-stroke

NCT03223571 | Completed DMC

• 1 other identifier: UF9858
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; Upper arm; Cerebral plasticity; Functional connectivity; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• change in anatomical connectivity

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

Other Outcomes (3)

• change in kinematic scores

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

• change in Fugl-Meyer upper-limb assessement score

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

• change in Lesion characteristics.

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

Study Arms (2)

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

Controls

Healthy people with no history of neurological pathologies

Interventions

Motor rehabilitation training OTHER

Post-stroke participants receive 6 week of rehabilitation training of the paretic upper-limb.

Early post-stroke (<2 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Isabelle LAFFONT, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 21, 2017
• Study Start: July 27, 2017
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

FR (1)