An interventional study of Clinical scores and functional MRI in Brain Diseases, Ischemic Stroke and Stroke, sponsored by Rennes University Hospital. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Other
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Compared within Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Non-Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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
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.
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 months
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 months
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 months
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 months
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 months
Changes in perfusion of brain data
Longitudinal analysis of perfusion (infratentorial, interhemispheric, intrahemispheric) according to recovery categories defined by the Fugl-Meyer score.
Time frame: From Day 7-Day 10 to 6 months
Changes in Degree of corticospinal FA ratio of brain data
Longitudinal analysis of the degree of FA ratio of the cortico-spinal tract (injured hemisphere / healthy hemisphere) according to the recovery categories defined by the Fugl-Meyer score.
Time frame: From Day 7-Day 10 to 6 months
Changes in patients' clinical profile in terms of motricity
Changes in Motor scores Motor index for upper and lower limbs according to recovery categories defined by the Fugl-Meyer score. The Motricity Index can be used to assess the motor impairment in a patient who has had a stroke. This test includes a motor test on the upper limb with a score from 0 to 100, combined with a motor test on the lower limb with a score from 0 to 100. The sum of these two scores is divided by 2 for a total out of 100. A high score indicates good recovery."
Time frame: 6 months
Changes in patients' clinical profile in terms of motricity
Changes in Action Research Arm Test (ARAT) score according to recovery categories defined by the Fugl-Meyer score. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, higher scores will indicate better performance. The ARAT scores is a continuous measure, with no categorical cutoff scores.
Time frame: 6 months
Changes in patients' clinical profile in quality of life
Progression in The Stroke Impact Scale (SIS) score according to recovery categories defined by the Fugl-Meyer score. The SIS contains 59 items measuring eight domains: strength (4 items), hand functionality (5 items), ADL / IADL (10 items), mobility (9 items), communication (7 items), emotions (9 items), memory / thinking (7 items), and social participation (8 items). A final item assessing overall stroke recovery is asked of the patient (score out of 100). The minimum score is 60, the maximum is 300. A high score indicates a good quality of life.
Time frame: 6 months
Changes in patients' clinical profile in independence
Progression in The Composite Functional Independence Scale (MIF) score according to recovery categories defined by the Fugl-Meyer score. The MIF consists of 18 items measuring patients' performance in performance in activities of daily living, including cognitive and relational aspects. For each item (from 1 to 18), the therapist chooses the patient's level of incapacity from 1 (total assistance) to 7 (total independence). The total score is calculated by adding up the disability level figures for each item. The minimum score is 18, the maximum is 126. A high score indicates complete independence.
Time frame: 6 months
Changes in patients' clinical profile in spasticity
Progression in Changes in Tardieu Scale according to recovery categories defined by the Fugl-Meyer score. The Tardieu Scale are clinical measures of muscle spasticity in patients with neurological conditions. The Tardieu Scale quantify spasticity by assessing the muscle's response to stretch applied at given velocities. The examiner evaluates the muscle group's reaction to stretch at a specified velocity with 2 parameters: X (quality of muscle reaction) and Y (angle of muscle reaction).
Time frame: 6 months
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score. The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke. 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: Day 7-Day 10
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score. The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke. 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: Day 30
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score. The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke. 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: 3 months
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score. The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke. 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 months
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score. This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: \> 25 - severe neurological deficits, 5-14 - moderate neurological deficits, \< 5 - mild deficits.
Time frame: Day 7-Day 10
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score. This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: \> 25 - severe neurological deficits, 5-14 - moderate neurological deficits, \< 5 - mild deficits.
Time frame: Day 30
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score. This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: \> 25 - severe neurological deficits, 5-14 - moderate neurological deficits, \< 5 - mild deficits.
Time frame: 3 months
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score. This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: \> 25 - severe neurological deficits, 5-14 - moderate neurological deficits, \< 5 - mild deficits.
Time frame: 6 months
Changes in neurological events
Changes in significant clinical worsening defined by a worsening of the NIHSS score by 4 points, epileptic seizure. This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: \> 25 - severe neurological deficits, 5-14 - moderate neurological deficits, \< 5 - mild deficits.
Time frame: From enrollment to the end of evaluation at 6 months
Plan to share: Undecided
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