fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients

Not Applicable

Completed

• Conditions: D020521
• Interventions: Diagnostic Test: Walking and Record Cortical Activity

• Registration Number: NCT03559283
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Study Start: 2018-11-26
• Status Verified: 2019-06
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Walking and Record Cortical Activity	Walking and Record Cortical Activity	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.

Primary Outcome Measures

Name	Time	Method
Cost of the Double Task	Day of the Inclusion	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

Name	Time	Method
Impact of the double task on spatio-temporal parameters of walking and on cognition	Day of the Inclusion	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	Day of the Inclusion	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).

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Limoges, France