Stroke Cerebral Reorganization Pathways (SPECTRE)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRennes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Clinical scores and functional MRI
Other interventionMotor 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: PatientsExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Changes in Effective connectivity of brain data
Longitudinal analysis of topological measures of effective connectivity graphs (between Region of interest (ROIs)) according to recovery categories defined by the Fugl-Meyer score.
Time frame
From Day 7-Day 10 to 6 months2
Changes in Structural connectivity of brain data
Analysis of topological measures of structural connectivity graphs according to recovery categories defined by the Fugl-Meyer score.
Time frame
From Day7-Day 10 to 6 months3
Changes in Modification of brain activity of brain data
Longitudinal analysis of brain activity (expressed as variation in BOLD hemodynamic response) at rest and during a motor task (between ROIs) according to recovery categories defined by the Fugl-Meyer score.
Time frame
From Day 7-Day 10 to 6 months4
Changes in Ipsilesional / contralesional laterality index of brain data
Longitudinal analysis of the ipsilesional/counterlesional laterality index of activations in sensorimotor areas according to recovery categories defined by the Fugl-Meyer score.
Time frame
From Day 7-Day 10 to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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