Clinical trial NCT06784518: Stroke Cerebral Reorganization Pathways (SPECTRE)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Brain Diseases
Ischemic Stroke
Stroke
Brain Infarction
Stroke Rehabilitation
Keywords: stroke
Rehabilitation
Upper Limb
Neuroplasticity
Connectivity
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, prospective, cohort, interventional study with minimal risks and constraints according to the Loi Jardé (RIPH2).

Longitudinal follow-up of patients.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in effective connectivity of Brain data (fMRI activity and CST tractography)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Effective connectivity of brain data
timeFrame: From Day 7-Day 10 to 6 months
measure: Changes in Structural connectivity of brain data
timeFrame: From Day7-Day 10 to 6 months
measure: Changes in Modification of brain activity of brain data
timeFrame: From Day 7-Day 10 to 6 months
measure: Changes in Ipsilesional / contralesional laterality index of brain data
timeFrame: From Day 7-Day 10 to 6 months
measure: Changes in perfusion of brain data
timeFrame: From Day 7-Day 10 to 6 months
measure: Changes in Degree of corticospinal FA ratio of brain data
timeFrame: From Day 7-Day 10 to 6 months
measure: Changes in patients' clinical profile in terms of motricity
timeFrame: 6 months
measure: Changes in patients' clinical profile in terms of motricity
timeFrame: 6 months
measure: Changes in patients' clinical profile in quality of life
timeFrame: 6 months
measure: Changes in patients' clinical profile in independence
timeFrame: 6 months
measure: Changes in patients' clinical profile in spasticity
timeFrame: 6 months
measure: Changes in clinical profile in terms of motor skills
timeFrame: Day 7-Day 10
measure: Changes in clinical profile in terms of motor skills
timeFrame: Day 30
measure: Changes in clinical profile in terms of motor skills
timeFrame: 3 months
measure: Changes in clinical profile in terms of motor skills
timeFrame: 6 months
measure: Changes in clinical profile in terms of of global impairment
timeFrame: Day 7-Day 10
measure: Changes in clinical profile in terms of of global impairment
timeFrame: Day 30
measure: Changes in clinical profile in terms of of global impairment
timeFrame: 3 months
measure: Changes in clinical profile in terms of of global impairment
timeFrame: 6 months
measure: Changes in neurological events
timeFrame: From enrollment to the end of evaluation at 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes Chu
Study officials:
affiliation: RENNES CHU
name: Maud GUILLEN, Md
role: PRINCIPAL_INVESTIGATOR
References: