Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT06784518
Eligibility Criteria:
Inclusion Criteria:
* Adult (age greater than or equal to 18 years) less than 75 years of age, both sexes;
* single supratentorial ischemic stroke confirmed by brain imaging
* Upper limb deficit defined by a SAFE score \<5 (SAFE Stinear protocol, prognosis of post-stroke upper limb recovery) on D3 of stroke. This corresponds to the sum of shoulder abduction and finger extension according to the MRC (Medical Research Council) scale for each of these movements out of 5.
* Absence of comprehension disorders limiting participation;
* Patient covered by french social security;
* Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature).
Non-Inclusion Criteria:
* Multiple ischemic strokes or history of clinically significant stroke ;
* Posterior fossa stroke ;
* Hemorrhagic stroke;
* Patient who have undergone thrombolysis or mechanical thrombectomy;
* Extensive Fazekas grade 3 vascular leukopathy;
* Pre-existing neurodegenerative pathology;
* Patient with severe dyspnea or swallowing disorders who cannot undergo brain MRI;
* Adults under legal protection (safeguard of justice, curatorship, guardianship, family habilitation), persons deprived of liberty;
* Women declaring that they are pregnant or breast-feeding;
* Patient participating in another therapeutic or drug intervention study that may have an impact on the effect of cerebral neuroplasticity on the SPECTRE study;
* Patients with contraindications to MRI pacemaker or implantable defibrillator, neurosurgical clips, cochlear implants, intra-orbital or encephalic metallic foreign bodies, stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago, claustrophobia.
Exclusion Criteria:
* If the prognostic group according to the PREP2 algorithm (good, limited and poor) has already been reached during motor evoked potential assessment the patient is excluded.
* Recurrence of clinically significant stroke (with worsening NIHSS score \> 4) during study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06784518
Study Brief:
Protocol Section:
NCT06784518