Clinical trial NCT04574037: Prediction of Post-stroke Motor Recovery
Official title: Prediction of Post-stroke Motor Recovery: the PREP-AVC Algorithm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Upper Limb Motor Deficit
Keywords: stroke
motor
prediction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients with upper limb motor deficits

Brief 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.

Detailed description: Retrospective cohort of stroke patients with a upper limb deficit.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. The accuracy of this prediction will be verified according to the actual state of the patient at 3-6 months. Second, another algorithm will be built taking in account cognitive deficits and biological data to determine if the accuracy is higher. All data will be acquired during the clinical routine work-up.

Eligibility criteria: 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 outcomes:
measure: Accuracy of classification with the PREP2 decision tree
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service des Urgences Cérébro-Vasculaires, Hôpital Pitié Salpêtrière
Study officials:
References: