Biomarkers to Predict Gain From Therapy in Motor Stroke

Not Applicable

Completed

• Conditions: Motor Activity; Stroke; Biomarker
• Interventions: Behavioral: standard stroke rehabilitation

• Registration Number: NCT03739892
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Start: 2019-01-08
• Primary Completion: 2021-06-26
• Study Completion: 2021-06-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stroke patients	standard stroke rehabilitation	stroke patients with upper limb motor deficit receiving standard care of rehab

Primary Outcome Measures

Name	Time	Method
Changes in a composite motor score post-pre training is the gain from therapy Candidates biomarkers: MRI, EEG, TMS, genotype	6 weeks between pre and post assessment	Changes in motor score Candidates biomarkers: MRI, EEG, TMS, genotypes post-pre training is the gain from therapy

Secondary Outcome Measures

Name	Time	Method
Changes in a composite motor score post-pre training is the gain from therapy	12 weeks between pre and post assessment	Changes in motor score Candidates biomarkers: MRI, EEG, TMS, genotypes post-pre training is the gain from therapy

Trial Locations

Locations (1)

ICM; 🇫🇷 Paris, France