Ireland
--:--IST
Recruiting Observational

Prediction of Post-stroke Motor Recovery

NCT04574037 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-04-21
Last updated
2024-02-05

Condition(s) studied

StrokeUpper Limb Motor Deficit

Investigational drug(s) / intervention(s)

Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential)

Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential): Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential) will determine the predictive functional outcome of the upper limb deficit according to the PREP2 algorithm.

Study summary

The prediction of motor recovery in the acute phase of stroke is crucial for several clinical reasons: (i) informing the patient and his relatives, (ii) helping to identify the patient's endorsement (return home or rehabilitation) as well as the adaptation of the rehabilitation program to what can be expected from it. To date, an algorithm (decision tree) proposed by C. Stinear's team named PREP2 is the best predictive tool with 75% of patients well classified at 3 months. It predicts the functional recovery of the upper limb after stroke 3 months before the episode by categorizing recovery as "excellent", "good", "limited" as well as "minor" (poor). With two data (SAFE score, age) or three (SAFE score, Motor evoked potential, NIHSS), the prediction is effective three times out of 4. In the study the team is proposing "PREP-UCV", it would like to validate this algorithm as it is with patients in the active file who are victims of stroke. The expected accuracy is 75% or more. As a secondary objective, the team would like to confirm that it find the same algorithm starting from the initial data from PREP 2 (side of the stroke, type of stroke (ischemic and / or hemorrhagic), involvement of the corticospinal tract on MRI, sex at birth ) as well as two other factors which are also very important: cognitive status (dysexecutive / aphasia / neglect), as well as the neutrophils on lymphocytes ratio.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * age ≥ 18 y-o, * admitted in the Pitié-Salpêtrière stroke unit, * stroke with a upper limb motor deficit, * agree to participate; Exclusion criteria: * contra-indication to MRI or TMS, * patients under legal guardianship , * patients without healthcare insurance

Primary outcome measure(s)

  • Accuracy of classification with the PREP2 decision tree — 6 months
    Proportion of patients well classified in their group of recovery

Trial sites (1)

FacilityCityRegionStatus
Service des Urgences Cérébro-Vasculaires, Hôpital Pitié Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04574037 on ClinicalTrials.gov ↗ ← All trials in France