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Biomarkers to Predict Gain From Therapy in Motor Stroke

Biomarkers to Predict Gain From Therapy in Motor Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03739892
Acronym
GAIN
Enrollment
23
Registered
2018-11-14
Start date
2019-01-08
Completion date
2021-06-26
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Motor Activity, Stroke

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.

Interventions

BEHAVIORALstandard stroke rehabilitation

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

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

physiopathological study

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in a composite motor score post-pre training is the gain from therapy Candidates biomarkers: MRI, EEG, TMS, genotype6 weeks between pre and post assessmentChanges in motor score Candidates biomarkers: MRI, EEG, TMS, genotypes post-pre training is the gain from therapy

Secondary

MeasureTime frameDescription
Changes in a composite motor score post-pre training is the gain from therapy12 weeks between pre and post assessmentChanges in motor score Candidates biomarkers: MRI, EEG, TMS, genotypes post-pre training is the gain from therapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026