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

Stroke Clinical Trial

— ERASM  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664636
• Other study ID #: LOCAL/2015/JF-02
• Secondary ID: 2015-A01624-45
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: August 25, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi	Le Grau du Roi
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 0	No
Primary	Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 15	No
Primary	Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 30	No
Primary	Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 45	No
Primary	Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation		Day 60	No
Primary	Near-infrared spectroscopy signal analysis: the amplitude peak		Day 0	No
Primary	Near-infrared spectroscopy signal analysis: the amplitude peak		Day 15	No
Primary	Near-infrared spectroscopy signal analysis: the amplitude peak		Day 30	No
Primary	Near-infrared spectroscopy signal analysis: the amplitude peak		Day 45	No
Primary	Near-infrared spectroscopy signal analysis: the amplitude peak		Day 60	No
Primary	Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 0	No
Primary	Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 15	No
Primary	Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 30	No
Primary	Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 45	No
Primary	Near-infrared spectroscopy signal analysis: the time required to reach the peak		Day 60	No
Primary	Near-infrared spectroscopy signal analysis: the laterality index		Day 0	No
Primary	Near-infrared spectroscopy signal analysis: the laterality index		Day 15	No
Primary	Near-infrared spectroscopy signal analysis: the laterality index		Day 30	No
Primary	Near-infrared spectroscopy signal analysis: the laterality index		Day 45	No
Primary	Near-infrared spectroscopy signal analysis: the laterality index		Day 60	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 0	No
Primary	Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 15	No
Primary	Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 30	No
Primary	Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 45	No
Primary	Voluntary force: coefficient of variation	Voluntary force refers to the force applied during motricity tasks.	Day 60	No
Primary	Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 0	No
Primary	Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 15	No
Primary	Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 30	No
Primary	Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 45	No
Primary	Fugl-Meyer motricity score	The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.	Day 60	No
Secondary	The Box and Block test: The score is the number of blocks transferred in one minute.		Day 0	No
Secondary	The Box and Block test: The score is the number of blocks transferred in one minute.		Day 60	No
Secondary	The Nine Hole Peg Test: The score is the total time to complete the task.		Day 0	No
Secondary	The Nine Hole Peg Test: The score is the total time to complete the task.		Day 60	No
Secondary	The Barthell test for autonomy		Day 0	No
Secondary	The Barthell test for autonomy		Day 60	No