Biomarkers to Predict Gain From Therapy in Motor Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2021-06-26

Brief Summary

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The aim is to determine predictors of treatment response, i.e gain from rehabilitation training, in post stroke upper limb deficits. The investigators will like to answer the following question: "What is this patient's potential for recovery, given his profile?" The investigators propose to conduct a longitudinal physiopathological study on the stroke patients with motor deficits who entered the rehab center of Pitié Salpêtrière hospital. The investigators will benefit from the organization, which is already in place (clinical asssessments and training) to add MRI, TMS and EEG recordings, as well as genotype analysis before the training offered in the rehabilitation unit. The investigators will repeat these assessments after the training (immeadiately and 6 weeks after).

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Detailed Description

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The protocol is based on 10 visits. The three main one are V1, V9 and V10. V1, V9 and V10 are the assessments visits with clinical scores, MRI TMS and EEG recordings. These are made before the training (V1), immediately after the 6 weeks of training (V9) and 6 weeks after (V10) V5 is a visit where the investigators will clinically assess the patients at three weeks of the training.

The other visits (V2, V3, V4, V6, V7, V8) consist in recording an EEG while patients are under training each week during six weeks.

Conditions

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Stroke Motor Activity Biomarker

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

physiopathological study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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stroke patients

stroke patients with upper limb motor deficit receiving standard care of rehab

Group Type OTHER

standard stroke rehabilitation

Intervention Type BEHAVIORAL

standard rehabilitation according to the french standard care and to the severity of the patient

Interventions

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standard stroke rehabilitation

standard rehabilitation according to the french standard care and to the severity of the patient

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

(i) First-ever stroke patients (ii) Upper limb motor impairment (Fugl Meyer scale) (iii) post stroke delay between 7 and 42 days (iv) affiliated to french health care (v) Suitable for task based oriented training in the rehab center

Exclusion Criteria

(i) age \< 18 or \> 85 years (ii) Hemianopia (iii) contra-indications to MRI or TMS assessments (iv) life threatening conditions (v) patients under legal protection (vi) pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No