Stroke Cerebral Reorganization Pathways (SPECTRE)

NCT06784518 | Not Yet Recruiting

• 2 other identifiers: 35RC22_9907-11_SPECTRE2024-A02034-43
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stroke; Rehabilitation; Upper Limb; Neuroplasticity; Connectivity

Outcome Measures

Primary Outcomes (1)

• Changes in effective connectivity of Brain data (fMRI activity and CST tractography)

  Descriptive analysis of topological measures of effective connectivity graphs as a function of effective motor recovery (Fugl-Meyer score - Upper Extremity) at 6 months. The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.

  6 months

Secondary Outcomes (20)

• Changes in Effective connectivity of brain data

  From Day 7-Day 10 to 6 months

• Changes in Structural connectivity of brain data

  From Day7-Day 10 to 6 months

• Changes in Modification of brain activity of brain data

  From Day 7-Day 10 to 6 months

• Changes in Ipsilesional / contralesional laterality index of brain data

  From Day 7-Day 10 to 6 months

• Changes in perfusion of brain data

  From Day 7-Day 10 to 6 months

Study Arms (1)

Patients

EXPERIMENTAL

Three prognostic groups according to the PREP2 algorithm (good, limited and poor). 21 evaluable patients divided into 3 balanced prognostic groups.

Other: Clinical scores and functional MRI

Interventions

Clinical scores and functional MRI 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.

Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes Chu

Rennes, France, 35033, France

Location

MeSH Terms

Conditions

Brain Diseases; Ischemic Stroke; Stroke; Brain Infarction

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Maud GUILLEN, Md

  RENNES CHU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maud GUILLEN, Md

CONTACT

299284122; maud.guillen@chu-rennes.fr

Isabelle LEROYER

CONTACT

299284321; isabelle.leroyer@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, cohort, interventional study with minimal risks and constraints according to the Loi Jardé (RIPH2). Longitudinal follow-up of patients.

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 20, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

FR (1)