Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06784518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-20
First Post:
2024-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stroke Cerebral Reorganization Pathways (SPECTRE)
Sponsor:
Rennes University Hospital
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPECTRE
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A02034-43 | REGISTRY | N° ID-RCB | View |