Stroke is a major cause of disability over the world. While acute therapies have made huge progresses, the number of survivors leaving with clinical consequences of stroke is increasing. Beyond stroke itself, secondary neurodegeneration of disconnected areas, especially of central hubs such as the substantia nigra or the thalamus, could significantly impact the overall outcome of the patients. Data have identified iron accumulation within the disconnected areas as potentially accelerating neurodegeneration. In this research, the main objective is test whether long-term chelation through Deferiprone (Ferrirpox®, Chiesi) administered daily from 3-to-5 days following stroke to 6 months could avoid iron accumulation as measured with Magnetic resonance imaging (MRI) within disconnected areas (substantia nigra). MRI imaging methods such as the quantification of the transverse relaxation rate R2\* provide highly correlated information to the histologically measured iron load
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Quantification of iron will be performed through Magnetic Resonance Imaging
Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d
CHU Bordeaux
Bordeaux, France
CHU de Lille
Lille, France
R2* Index within the homolateral black substance
Iron load : 95th percentile of the values of MRI R2\*
Time frame: Day 1
R2* Index within the homolateral black substance
Iron load : 95th percentile of the values of MRI R2\*
Time frame: 6 Month
R2* Index within the thalamus and the middle nucleus of the homolateral thalamus
Iron load : 95th percentile of the values of MRI R2\*
Time frame: Day 1
R2* Index within the thalamus and the middle nucleus of the homolateral thalamus
Iron load : 95th percentile of the values of MRI R2\*
Time frame: 6 Month
R2* Relaxivity values
R2\* relaxivity values (95th percentile) measured on MRI
Time frame: Day 1
R2* Relaxivity values
R2\* relaxivity values (95th percentile) measured on MRI
Time frame: 6 Month
Fugl-Meyer Score
Fugl Meyer Upper Limb Motor Scale assesses tone, strength and motor of upper limbs. The total score is on 66 points for the upper limbs to which the evaluation will be limited. A higher score indicates better motor performance. The test time is about 20 minutes.
Time frame: Day 1
Fugl-Meyer Score
Fugl Meyer Upper Limb Motor Scale assesses tone, strength and motor of upper limbs. The total score is on 66 points for the upper limbs to which the evaluation will be limited. A higher score indicates better motor performance. The test time is about 20 minutes.
Time frame: 3 Month
Fugl-Meyer Score
Fugl Meyer Upper Limb Motor Scale assesses tone, strength and motor of upper limbs. The total score is on 66 points for the upper limbs to which the evaluation will be limited. A higher score indicates better motor performance. The test time is about 20 minutes.
Time frame: 6 Month
Box and Block test Score
Manual dexterity of the upper limbs. The test consists of a 2-compartment box containing 150 blocks in one compartment. The patient must pass the maximum number of blocks to the second compartment in 1 minute. The maximum score is 150. A higher score indicates better manual dexterity. The score is evaluated for the right hand and left hand. The test duration is 5 minutes.
Time frame: Day 1
Box and Block test Score
Manual dexterity of the upper limbs. The test consists of a 2-compartment box containing 150 blocks in one compartment. The patient must pass the maximum number of blocks to the second compartment in 1 minute. The maximum score is 150. A higher score indicates better manual dexterity. The score is evaluated for the right hand and left hand. The test duration is 5 minutes.
Time frame: 3 Month
Box and Block test Score
Manual dexterity of the upper limbs. The test consists of a 2-compartment box containing 150 blocks in one compartment. The patient must pass the maximum number of blocks to the second compartment in 1 minute. The maximum score is 150. A higher score indicates better manual dexterity. The score is evaluated for the right hand and left hand. The test duration is 5 minutes.
Time frame: 6 Month
Modified Rankin scale Score
Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability
Time frame: Day 1
Modified Rankin scale Score
Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability
Time frame: 3 Month
Modified Rankin scale Score
Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability
Time frame: 6 Month
Montreal cognitive assessment (MoCA) Score
Cognitive functions evaluation in the areas of attention, concentration, executive functions, episodic memory, language, constructive visual practices, abstract abilities, computation and orientation. The maximum score is 30 points and the pathological threshold is 26/30. The duration of passing is about 15 minutes.
Time frame: Day 1
Montreal cognitive assessment (MoCA) Score
Cognitive functions evaluation in the areas of attention, concentration, executive functions, episodic memory, language, constructive visual practices, abstract abilities, computation and orientation. The maximum score is 30 points and the pathological threshold is 26/30. The duration of passing is about 15 minutes.
Time frame: 3 Month
Montreal cognitive assessment (MoCA) Score
Cognitive functions evaluation in the areas of attention, concentration, executive functions, episodic memory, language, constructive visual practices, abstract abilities, computation and orientation. The maximum score is 30 points and the pathological threshold is 26/30. The duration of passing is about 15 minutes.
Time frame: 6 Month
Center for epidemiologic studies depression scale (CES-D)
Existence of a depressive syndrome. It consists of 20 moral status questions in the previous week that the patient answers on a 6-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 20 questions and ranges from 0 to 60. The score is higher the more severe the depressive disorders. The depressive threshold is typically considered to be \>23 in women and \>17 in men. The transfer time is about 10 minutes.
Time frame: Day 1
Center for epidemiologic studies depression scale (CES-D)
Existence of a depressive syndrome. It consists of 20 moral status questions in the previous week that the patient answers on a 6-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 20 questions and ranges from 0 to 60. The score is higher the more severe the depressive disorders. The depressive threshold is typically considered to be \>23 in women and \>17 in men. The transfer time is about 10 minutes.
Time frame: 3 Month
Center for epidemiologic studies depression scale (CES-D)
Existence of a depressive syndrome. It consists of 20 moral status questions in the previous week that the patient answers on a 6-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 20 questions and ranges from 0 to 60. The score is higher the more severe the depressive disorders. The depressive threshold is typically considered to be \>23 in women and \>17 in men. The transfer time is about 10 minutes.
Time frame: 6 Month
Generalized anxiety disorder scale (GAD-7) scale
Anxiety disorders assessment through 7 questions on items related to anxiety experienced during the previous 14 days that the patient answers on a 4-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 7 questions and ranges from 0 to 21. The higher the score, the more severe the anxiety disorders. The thresholds are usually: 0-4 points = no anxiety; 5-9 points = mild anxiety; 10-14 points = moderate anxiety; 15-21 points = severe anxiety. The transfer time is 5 to 10 minutes.
Time frame: Day 1
Generalized anxiety disorder scale (GAD-7) scale
Anxiety disorders assessment through 7 questions on items related to anxiety experienced during the previous 14 days that the patient answers on a 4-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 7 questions and ranges from 0 to 21. The higher the score, the more severe the anxiety disorders. The thresholds are usually: 0-4 points = no anxiety; 5-9 points = mild anxiety; 10-14 points = moderate anxiety; 15-21 points = severe anxiety. The transfer time is 5 to 10 minutes.
Time frame: 3 Month
Generalized anxiety disorder scale (GAD-7) scale
Anxiety disorders assessment through 7 questions on items related to anxiety experienced during the previous 14 days that the patient answers on a 4-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 7 questions and ranges from 0 to 21. The higher the score, the more severe the anxiety disorders. The thresholds are usually: 0-4 points = no anxiety; 5-9 points = mild anxiety; 10-14 points = moderate anxiety; 15-21 points = severe anxiety. The transfer time is 5 to 10 minutes.
Time frame: 6 Month
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