fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients (ICM-AVC)
Primary Purpose
D020521
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Walking and Record Cortical Activity
Sponsored by

About this trial
This is an interventional diagnostic trial for D020521 focused on measuring stroke, dual-task, gait parameters, fNIRS
Eligibility Criteria
Inclusion Criteria:
- patient between 55 and 75 years old
- First stroke
- ischemic sylvian or hemorrhagic lobar deep respecting the frontal lobe, subacute phase (J15-J90),
- patient walking 10 meters.
Exclusion Criteria:
- Heminegligencia,
- a history of neurological pathologies, orthopedic pathologies, aphasia, cognitive disorders preceding stroke (dementia, head trauma), acute cardiovascular or respiratory pathologies.
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Walking and Record Cortical Activity
Arm Description
A sensor placement will be performed on the patient's forehead to record brain activity when walking, when performing a mental task, and when performing both tasks at the same time. In parallel, walking will be on a carpet that will record the spatio-temporal parameters of walking.
Outcomes
Primary Outcome Measures
Cost of the Double Task
the double task (DT) cost measured by the average difference in magnitude of hemodynamic responses in HbO2 at the CPF level obtained by the fNIRS between the DT high and low cognitive load.
Secondary Outcome Measures
Impact of the double task on spatio-temporal parameters of walking and on cognition
Spatio-temporal parameters (walking speed, walking time, cadence, pitch length and pitch variability) of walking, measured on GAITRite as a function of the cognitive load of the Double Task (DT)
Evaluate the asymmetry of cerebral activation in different walking conditions
Measurement of the mean difference of hemodynamic HbO2 activation of the CPF between the lesional side and the contralateral side by fNIRS as a function of the cognitive load in Double Task (DT).
Full Information
NCT ID
NCT03559283
First Posted
June 6, 2018
Last Updated
January 3, 2020
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT03559283
Brief Title
fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
Acronym
ICM-AVC
Official Title
Using Functional Near-infrared Spectroscopy (fNIRS) in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
June 26, 2019 (Actual)
Study Completion Date
June 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates cognitive-motor interference in stroke patients who is responsible an alteration of spatio-temporal gait parameters. It's proved in the literature but the underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional imaging technique that evaluates this interference under optimal conditions. The purpose of this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients under different DT conditions.
Detailed Description
Walking is a motor task that involves cognitive functions. The parameters of walking and brain activity are modified in situations requiring significant attentional and cognitive demand. fNIRS is an interesting functional neuroimaging technique for studying cortical activity when performing a Dual Task (DT). To our knowledge, no studies have examined cerebral oxygenation levels in post-stroke patients based on different cognitive loads during walking. Understanding cognitive contributions in a dual-task walking situation is necessary to providing targeted interventions and preventing falls.
Patients included in the study will be evaluated in single cognitive task, with two levels of difficulty, single walking motor task, and dual task with two levels of cognitive difficulty. The fNIRS will record the hemodynamic activity of the prefrontal cortex for the cognitive slope and the GAITRite will record the walking parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
D020521
Keywords
stroke, dual-task, gait parameters, fNIRS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking and Record Cortical Activity
Arm Type
Experimental
Arm Description
A sensor placement will be performed on the patient's forehead to record brain activity when walking, when performing a mental task, and when performing both tasks at the same time. In parallel, walking will be on a carpet that will record the spatio-temporal parameters of walking.
Intervention Type
Diagnostic Test
Intervention Name(s)
Walking and Record Cortical Activity
Intervention Description
The cortical activity of each patient is recorded by NIRS under the following conditions:
Simple task : The patient walks on an electronic walking track (GAITRite system) over 10 meters. The data collected are the spatio-temporal parameters of walking.
Cognitive task alone : two conditions of the n-back test (1-back and 2-back) to study neural activities related to working memory. The duration of realization will be 30 seconds by condition and we retain the number of errors realized.
Double Task : Achievement of the motor task (10-meter walk) is performed at the same time as a "weak" cognitive task (1-back) and a "high" cognitive task (2-back). The spatio-temporal parameters and the number of errors are collected by the observer.
Primary Outcome Measure Information:
Title
Cost of the Double Task
Description
the double task (DT) cost measured by the average difference in magnitude of hemodynamic responses in HbO2 at the CPF level obtained by the fNIRS between the DT high and low cognitive load.
Time Frame
Day of the Inclusion
Secondary Outcome Measure Information:
Title
Impact of the double task on spatio-temporal parameters of walking and on cognition
Description
Spatio-temporal parameters (walking speed, walking time, cadence, pitch length and pitch variability) of walking, measured on GAITRite as a function of the cognitive load of the Double Task (DT)
Time Frame
Day of the Inclusion
Title
Evaluate the asymmetry of cerebral activation in different walking conditions
Description
Measurement of the mean difference of hemodynamic HbO2 activation of the CPF between the lesional side and the contralateral side by fNIRS as a function of the cognitive load in Double Task (DT).
Time Frame
Day of the Inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient between 55 and 75 years old
First stroke
ischemic sylvian or hemorrhagic lobar deep respecting the frontal lobe, subacute phase (J15-J90),
patient walking 10 meters.
Exclusion Criteria:
Heminegligencia,
a history of neurological pathologies, orthopedic pathologies, aphasia, cognitive disorders preceding stroke (dementia, head trauma), acute cardiovascular or respiratory pathologies.
Facility Information:
Facility Name
University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
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