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NCT04574037: PREP-AVC

Prediction of Post-stroke Motor Recovery

Recruiting now Last updated 5 February 2024
What this trial tests

trial testing Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential) in Stroke in 200 participants. Currently enrolling.

Timeline
21 April 2021
Primary endpoint
1 October 2027
1 October 2027

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date21 April 2021
Primary completion1 October 2027
Estimated completion1 October 2027
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Stroke or Upper Limb Motor Deficit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Stroke

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

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Data sources for this page

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