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NCT06784518

Stroke Cerebral Reorganization Pathways (SPECTRE)

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

Summary

SPECTRE is a prospective longitudinal study in order to identify whether patients with different degrees of motor recovery are distinguished by distinct brain post-stroke plasticity patterns in the acute and sub-acute phases. This study allows close longitudinal follow-up of patients with severe clinical motor impairment using functional MRI to study cerebral neuroplasticity after ischemic stroke in the acute and sub-acute phase in patients with upper limb motor impairement, taking into account prognostic criteria used in current practice.

Official title: Stroke Cerebral Reorganization Pathways Longitudinal Study After Stroke of the Clinical Motor Pattern and the Cerebral Reorganization According to the Different Damaged Motor Pathways (Main and Accessory) (SPECTRE)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-01

Completion Date

2029-03

Last Updated

2026-04-02

Healthy Volunteers

Conditions

Brain Diseases Ischemic Stroke Stroke Brain Infarction Stroke Rehabilitation

Interventions

OTHER

Clinical scores and functional MRI

Motor evoked potentials between Day 3-Day 7 of the stroke, for a equal distribution of patients into three prognostic groups according to the PREP2 algorithm (good, limited and poor). Longitudinal follow-up with clinical scores and functional MRI at Day 7-Day 10, Day 30, Month 3 and Month 6 of stroke.

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.

Locations (1)

Rennes Chu

Rennes, France, France