Clinical trial NCT02664636: Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study
Official title: Pilot Study on the Development of Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium in the Post-stroke Early Recovery Phase Evaluated by Functional Near-infrared Spectroscopy (fNIRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.

Detailed description: The secondary objectives of this study are:

A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from Day 0 to Day 60.

B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.

Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient presents with a severe cognitive disorder
* The patient has severe aphasia with a Boston Diagnostic Aphasia Examination (BDAE) scale score strictly less than 2
* The patient has heminegligence with a bells test \> 6 on the left.
* The patient presents with limited amplitude in the paretic upper limb (shoulder abduction \<60°, elbow flexion \> 30° or dorsal wrist flexion \<20°).
* Imbalanced/uncontrolled epilepsy

Primary outcomes:
measure: Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
timeFrame: Day 0
measure: Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
timeFrame: Day 15
measure: Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
timeFrame: Day 30
measure: Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
timeFrame: Day 45
measure: Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
timeFrame: Day 60
measure: Near-infrared spectroscopy signal analysis: the amplitude peak
timeFrame: Day 0
measure: Near-infrared spectroscopy signal analysis: the amplitude peak
timeFrame: Day 15
measure: Near-infrared spectroscopy signal analysis: the amplitude peak
timeFrame: Day 30
measure: Near-infrared spectroscopy signal analysis: the amplitude peak
timeFrame: Day 45
measure: Near-infrared spectroscopy signal analysis: the amplitude peak
timeFrame: Day 60
measure: Near-infrared spectroscopy signal analysis: the time required to reach the peak
timeFrame: Day 0
measure: Near-infrared spectroscopy signal analysis: the time required to reach the peak
timeFrame: Day 15
measure: Near-infrared spectroscopy signal analysis: the time required to reach the peak
timeFrame: Day 30
measure: Near-infrared spectroscopy signal analysis: the time required to reach the peak
timeFrame: Day 45
measure: Near-infrared spectroscopy signal analysis: the time required to reach the peak
timeFrame: Day 60
measure: Near-infrared spectroscopy signal analysis: the laterality index
timeFrame: Day 0
measure: Near-infrared spectroscopy signal analysis: the laterality index
timeFrame: Day 15
measure: Near-infrared spectroscopy signal analysis: the laterality index
timeFrame: Day 30
measure: Near-infrared spectroscopy signal analysis: the laterality index
timeFrame: Day 45
measure: Near-infrared spectroscopy signal analysis: the laterality index
timeFrame: Day 60
measure: Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
timeFrame: Day 0
measure: Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
timeFrame: Day 15
measure: Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
timeFrame: Day 30
measure: Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
timeFrame: Day 45
measure: Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
timeFrame: Day 60
measure: Voluntary force: average
timeFrame: Day 0
measure: Voluntary force: average
timeFrame: Day 15
measure: Voluntary force: average
timeFrame: Day 30
measure: Voluntary force: average
timeFrame: Day 45
measure: Voluntary force: average
timeFrame: Day 60
measure: Voluntary force: coefficient of variation
timeFrame: Day 0
measure: Voluntary force: coefficient of variation
timeFrame: Day 15
measure: Voluntary force: coefficient of variation
timeFrame: Day 30
measure: Voluntary force: coefficient of variation
timeFrame: Day 45
measure: Voluntary force: coefficient of variation
timeFrame: Day 60
measure: Fugl-Meyer motricity score
timeFrame: Day 0
measure: Fugl-Meyer motricity score
timeFrame: Day 15
measure: Fugl-Meyer motricity score
timeFrame: Day 30
measure: Fugl-Meyer motricity score
timeFrame: Day 45
measure: Fugl-Meyer motricity score
timeFrame: Day 60
Secondary outcomes:
measure: The Box and Block test: The score is the number of blocks transferred in one minute.
timeFrame: Day 0
measure: The Box and Block test: The score is the number of blocks transferred in one minute.
timeFrame: Day 60
measure: The Nine Hole Peg Test: The score is the total time to complete the task.
timeFrame: Day 0
measure: The Nine Hole Peg Test: The score is the total time to complete the task.
timeFrame: Day 60
measure: The Barthell test for autonomy
timeFrame: Day 0
measure: The Barthell test for autonomy
timeFrame: Day 60
Other outcomes:
Locations:
city: Le Grau du Roi
country: France
facility: CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jérôme Froger, MD
role: PRINCIPAL_INVESTIGATOR
References: