Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium Post-stroke: a Pilot Study (ERASM)

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)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Procedure: Physiotherapy; Procedure: Occupational therapy; Procedure: Functional near-infrared spectroscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Grau du Roi, France, 30240
    • CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The study population; The study population consists of patients 20 and 75 years of age who have had a supra-tentorial ischemic or hemorrhagic stroke. The study covers consulting or hospitalized patients at the neurological rehabilitation service (NHS) of Grau du Roi Medical Center, part of the Nîmes University Hospital. Most patients originate from a 2-4 week stay in the neurological acute care, cardiac or polyvalent departments of the University Hospitals of Montpellier or Nîmes. Intervention: Physiotherapy Intervention: Occupational therapy Intervention: Functional near-infrared spectroscopy

Procedure: Physiotherapy; Physiotherapy regimen (days 0 to 60): orthopedic maintenance, work on trunk balance, sensorimotor techniques for restoration of motor skills, exercises for standing balance and walking. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. They occur as daily sessions during the first two weeks and then two sessions / day. This is part of routine care.; Procedure: Occupational therapy; Occupational Therapy (days 0 to 60): Orthopaedic maintenance, exercises for sitting and standing balance, sensorimotor techniques for the restoration of motor skills, grip exercises. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. 1 session is performed per day. This is part of routine care.; Procedure: Functional near-infrared spectroscopy; During the therapy protocol, cortical activation measures using the fNIRS method will be conducted every 15 days (at Day0, Day 15, Day 30, Day 45 and Day 60 for 5 sessions in total) at the technical platform of the Grau du Roi physical therapy centre, during the completion of a standardized motor task (maintaining a level of force) using the healthy upper limb and the paretic upper limb.; Other Names: fNIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 0
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 15
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 30
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 45
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 60
Near-infrared spectroscopy signal analysis: the amplitude peak		Day 0
Near-infrared spectroscopy signal analysis: the amplitude peak		Day 15
Near-infrared spectroscopy signal analysis: the amplitude peak		Day 30
Near-infrared spectroscopy signal analysis: the amplitude peak		Day 45
Near-infrared spectroscopy signal analysis: the amplitude peak		Day 60
Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 0
Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 15
Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 30
Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 45
Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 60
Near-infrared spectroscopy signal analysis: the laterality index		Day 0
Near-infrared spectroscopy signal analysis: the laterality index		Day 15
Near-infrared spectroscopy signal analysis: the laterality index		Day 30
Near-infrared spectroscopy signal analysis: the laterality index		Day 45
Near-infrared spectroscopy signal analysis: the laterality index		Day 60
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength	Voluntary force refers to the force applied during motricity tasks.	Day 0
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength	Voluntary force refers to the force applied during motricity tasks.	Day 15
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength	Voluntary force refers to the force applied during motricity tasks.	Day 30
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength	Voluntary force refers to the force applied during motricity tasks.	Day 45
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength	Voluntary force refers to the force applied during motricity tasks.	Day 60
Voluntary force: average	Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.	Day 0
Voluntary force: average	Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.	Day 15
Voluntary force: average	Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.	Day 30
Voluntary force: average	Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.	Day 45
Voluntary force: average	Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.	Day 60
Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 0
Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 15
Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 30
Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 45
Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 60
Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 0
Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 15
Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 30
Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 45
Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 60

Secondary Outcome Measures

Outcome Measure	Time Frame
The Box and Block test: The score is the number of blocks transferred in one minute.	Day 0
The Box and Block test: The score is the number of blocks transferred in one minute.	Day 60
The Nine Hole Peg Test: The score is the total time to complete the task.	Day 0
The Nine Hole Peg Test: The score is the total time to complete the task.	Day 60
The Barthell test for autonomy	Day 0
The Barthell test for autonomy	Day 60

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jérôme Froger, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: LOCAL/2015/JF-02; 2015-A01624-45 (Other Identifier: RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO