Back to resultsBiomarkers to Predict Gain From Therapy in Motor Stroke (GAIN)
Primary Purpose
Stroke, Motor Activity, Biomarker
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard stroke rehabilitation
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
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
Sites / Locations
- ICM
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
stroke patients
Arm Description
stroke patients with upper limb motor deficit receiving standard care of rehab
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03739892
First Posted
November 5, 2018
Last Updated
November 9, 2018
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03739892
Brief Title
Biomarkers to Predict Gain From Therapy in Motor Stroke
Acronym
GAIN
Official Title
Biomarkers to Predict Gain From Therapy in Motor Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Activity, Biomarker
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
physiopathological study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stroke patients
Arm Type
Other
Arm Description
stroke patients with upper limb motor deficit receiving standard care of rehab
Intervention Type
Behavioral
Intervention Name(s)
standard stroke rehabilitation
Intervention Description
standard rehabilitation according to the french standard care and to the severity of the patient
Primary Outcome Measure Information:
Title
Changes in a composite motor score post-pre training is the gain from therapy Candidates biomarkers: MRI, EEG, TMS, genotype
Description
Changes in motor score Candidates biomarkers: MRI, EEG, TMS, genotypes post-pre training is the gain from therapy
Time Frame
6 weeks between pre and post assessment
Secondary Outcome Measure Information:
Title
Changes in a composite motor score post-pre training is the gain from therapy
Description
Changes in motor score Candidates biomarkers: MRI, EEG, TMS, genotypes post-pre training is the gain from therapy
Time Frame
12 weeks between pre and post assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte ROSSO, MD PhD
Phone
+33142162103
Email
charlotte.rosso@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Dupont, MD PhD
Phone
+33142164115
Email
sophie.dupont@aphp.fr
Facility Information:
Facility Name
ICM
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Rosso, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Biomarkers to Predict Gain From Therapy in Motor Stroke
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