Stroke Cerebral Reorganization Pathways (SPECTRE)

Launched by RENNES UNIVERSITY HOSPITAL · Jan 17, 2025

Keywords

ClinConnect Summary

The SPECTRE clinical trial is designed to study how the brain adapts and changes after a stroke, particularly in patients who experience different levels of recovery in their ability to move. Researchers want to understand how these changes, known as brain plasticity, happen in the early phases after an ischemic stroke, which is caused by a blockage of blood flow to the brain. The study will use special brain imaging techniques to observe these changes in participants who have difficulty using their arms.

To participate in this trial, individuals must be between the ages of 18 and 75 and have had a single ischemic stroke confirmed by imaging. They should also show a specific level of arm movement impairment as measured by a standard test. Participants will need to give their consent, and those who cannot sign due to physical limitations can have a family member help. It's important to note that people with certain medical histories, such as multiple strokes or specific conditions affecting the brain, will not be eligible to join. Throughout the study, participants can expect regular follow-ups and brain scans to help researchers learn more about recovery after a stroke.

Gender

ALL

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.