fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
ICM-AVC
Using Functional Near-infrared Spectroscopy (fNIRS) in the Evaluation of Cognitive-motor Interference in Post-stroke Patients
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2018
CompletedFirst Posted
Study publicly available on registry
June 18, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2019
CompletedMarch 27, 2026
June 1, 2019
7 months
June 6, 2018
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day of the Inclusion
Secondary Outcomes (2)
Impact of the double task on spatio-temporal parameters of walking and on cognition
Day of the Inclusion
Evaluate the asymmetry of cerebral activation in different walking conditions
Day of the Inclusion
Study Arms (1)
Walking and Record Cortical Activity
EXPERIMENTALA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Heminegligencia,
- a history of neurological pathologies, orthopedic pathologies, aphasia, cognitive disorders preceding stroke (dementia, head trauma), acute cardiovascular or respiratory pathologies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Limoges, 87042, France
Related Publications (1)
Hermand E, Tapie B, Dupuy O, Fraser S, Compagnat M, Salle JY, Daviet JC, Perrochon A. Prefrontal Cortex Activation During Dual Task With Increasing Cognitive Load in Subacute Stroke Patients: A Pilot Study. Front Aging Neurosci. 2019 Jul 2;11:160. doi: 10.3389/fnagi.2019.00160. eCollection 2019.
PMID: 31312136RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2018
First Posted
June 18, 2018
Study Start
November 26, 2018
Primary Completion
June 26, 2019
Study Completion
June 26, 2019
Last Updated
March 27, 2026
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share