Stroke Cerebral Reorganization Pathways (SPECTRE)

NCT ID: NCT06784518

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-02-01

Brief 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.

Detailed Description

Patients are recruited as they are admitted to the neurovascular department. The SAFE score from the Stinear study is taken on Day 3 of the stroke, followed by 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.

Patients will ultimately be classified and analyzed according to their effective motor recovery at 6 months, using the Fugl-Meyer score.

The investigators will then conduct a comprehensive analysis of brain connectivity, examining both the anatomical structure of the brain, its functional activity and the dynamic interactions between certain regions of interest over time.

Conditions

Brain Diseases; Ischemic Stroke; Stroke; Brain Infarction; Stroke Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients

Three prognostic groups according to the PREP2 algorithm (good, limited and poor).

21 evaluable patients divided into 3 balanced prognostic groups.

Group Type: EXPERIMENTAL

Clinical scores and functional MRI

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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).

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maud GUILLEN, Md

Role: PRINCIPAL_INVESTIGATOR

RENNES CHU

Locations

Rennes Chu

Rennes, France, France

Countries

France

Central Contacts

Maud GUILLEN, Md

Role: CONTACT

maud.guillen@chu-rennes.fr

299284122 ext. +33

Isabelle LEROYER

Role: CONTACT

isabelle.leroyer@chu-rennes.fr

299284321 ext. +33

Facility Contacts

Maud GUILLEN, Md

Role: primary

maud.guillen@chu-rennes.fr

299284122 ext. +33

Maud GUILLEN, Md

Role: backup

Clément TRACOL, Md

Role: backup

Simon BUTET, Md

Role: backup

Stéphanie LEPLAIDEUR, Md

Role: backup

Other Identifiers

2024-A02034-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

35RC22_9907-11_SPECTRE

Identifier Type: -

Identifier Source: org_study_id