Biomarkers to Predict Gain From Therapy in Motor Stroke

Stroke Clinical Trial

— GAIN  

Official title:

Biomarkers to Predict Gain From Therapy in Motor Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03739892
• Other study ID #: C17-54
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: October 2020

Study information

• Verified date: November 2018
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Charlotte ROSSO, MD PhD
• Phone: +33142162103
• Email: charlotte.rosso[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Biomarker
• Motor Activity
• Stroke

Intervention

Behavioral:
• standard stroke rehabilitation
standard rehabilitation according to the french standard care and to the severity of the patient

Locations

Country	Name	City	State
France	ICM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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