Biomarkers to Predict Gain From Therapy in Motor Stroke

NCT03739892 | Completed

• 1 other identifier: C17-54
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Motor Activity; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in a composite motor score post-pre training is the gain from therapy

  12 weeks between pre and post assessment

Study Arms (1)

stroke patients

OTHER

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

Behavioral: standard stroke rehabilitation

Interventions

standard stroke rehabilitation BEHAVIORAL

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

stroke patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

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

Study Sites (1)

ICM

Paris, 75013, France

Location

Related Publications (1)

• 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.

  PMID: 37521287 BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: physiopathological study

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 14, 2018
• Study Start: January 8, 2019
• Primary Completion: June 26, 2021
• Study Completion: June 26, 2021
• Last Updated: August 29, 2025

Record last verified: 2025-03

Locations

FR (1)