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NCT04574037Recruiting

Prediction of Post-stroke Motor Recovery

Prediction of Post-stroke Motor Recovery: the PREP-AVC Algorithm

Source: ClinicalTrials.gov · Last updated 5 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
28 Sept 2020
Start date
21 Apr 2021
Primary completion date
1 Oct 2027
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Stroke
NCT number
NCT04574037

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 21 Apr 2021 to the primary completion date, 1 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • contra-indication to MRI or TMS,
  • patients under legal guardianship ,
  • patients without healthcare insurance

Who the study is looking for

  • age ≥ 18 y-o,
  • admitted in the Pitié-Salpêtrière stroke unit,
  • stroke with a upper limb motor deficit,
  • agree to participate;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service des Urgences Cérébro-Vasculaires, Hôpital Pitié Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.