Biomarkers to Predict Gain From Therapy in Motor Stroke (GAIN)

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Motor Activity; Biomarker
• Intervention / Treatment: Behavioral: standard stroke rehabilitation

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • ICM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: stroke patients; stroke patients with upper limb motor deficit receiving standard care of rehab	Behavioral: standard stroke rehabilitation; standard rehabilitation according to the french standard care and to the severity of the patient

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• Jacquemont T, Valabregue R, Daghsen L, Moulton E, Zavanone C, Lamy JC, Rosso C. Association between superior longitudinal fasciculus, motor recovery, and motor outcome after stroke: a cohort study. Front Neurol. 2023 Jul 14;14:1157625. doi: 10.3389/fneur.2023.1157625. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Actual): June 26, 2021
• Study Completion (Actual): June 26, 2021

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Stroke; Motor Activity
• Other Study ID Numbers: C17-54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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