Walking and Thinking - Brain Activity During Complex Walking in People With Multiple Sclerosis

Study Overview
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Brief Summary
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Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as Multiple Sclerosis (MS) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions. The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. The investigators aim therefore to explore brain function during complex walking in MS (in comparison with people with Parkinson's disease and healthy controls) by investigating the effects of neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in people with MS (in comparison with people with Parkinson's disease and healthy adults).

Official Title
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Walking and Thinking - Brain Activity During Complex Walking in People With Multiple Sclerosis

Conditions
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Aging, Multiple Sclerosis, Gait Disorders, Neurologic, Neuro-Degenerative Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older with an MS diagnosis according to McDonald criteria with the ability to walk without a mobility device for ≥5 minutes continuously. Exclusion Criteria: Disease or condition that affects cognition, gait or balance. MS relapse or change of disease-modifying treatment within the past eight weeks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis<br>People with Multiple Sclerosis, 18 years or older | Other: No intervention<br>* Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions. Dual-task walking with the auditory stroop task. Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right Navigational and dual-task walking (condition 1 and 2 together)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional near infrared spectrometry (fNIRS) | The measurement of changes in concentration of HbO and HHb in the prefrontal cortex will be assessed using a NIRSPORT 2 (NIRx Medizintechnik, Berlin, Germany) device. | During the test session during all three conditions | 
| Gait performance during all conditions | Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system. | During the test session during all three conditions | 
| Dual-task performance-reaction time | Cognitive performance of the dual task will be assessed as errors in the response to the Auditory stroop task. | During the test session during complex walking condition 1 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function- composite score | The cognitive test battery comprised the following tests: The Color-Word Interference Test (CWIT), Verbal Fluency, Trail Making Test (TMT) and Ray Auditory Verbal Learning Test (RAVLT) and Symbol Digit Modalities Test (SDMT). Cognitive function will be assessed as a composite measure of these test together. | During the test session, takes about 50 minutes | 
| Cognitive function - verbal fluency | Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System). | During the test session, takes about 12 minutes | 
| Cognitive function - Attention and psychomotor processing speed | Attention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System). | During the test session, takes about 3 minutes | 
| Cognitive function - Episodic memory | Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT). | During the test session, takes about 30 minutes | 
| Cognitive function - Cognitive processing speed | Cognitive processing speed will be assessed with the Symbol Digit Modalities Test (SDMT) | During the test session, takes about 3 minutes | 
| Cognitive function - Inhibition & task-set switching | Inhibition & task-set switching with the The Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System). | During the test session, takes about 5 minutes | 
| Self-reported level of physical activity | Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better) | Will be answered before the test session in the patients home or during the test session | 
| Physical activity level and intensity | Assessed with accelerometers (Actigraph GT3X+) | For one week after the test session | 
| Overall MS-disability | Assessed with the Expanded Disability Status Scale (EDSS). Higher scores=worse/more severe disability | During the test session | 
| Balance performance | Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p. | During the test session | 
| Anxiety and depression | Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better | Will be answered before the test session in the patients home or during the test session | 
| Walking ability | Self-assessed walking ability with the WALK-12G. | Will be answered before the test session in the patients home or at the test session | 
| Dual-task performance -errors | Cognitive performance of the dual task will be assessed as the reaction time to respond during Auditory stroop | During the test session during dual task conditions | 
| Disability | WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse | Will be answered before the test session in the patients home or during the test session | 
| Impact of Fatigue | Self-assessed impact of fatigue on physical, cognitive, and psychosocial functioning, with the Modified Fatigue Impact Scale (MFIS). 21 items, scored from 0 to 4. Higher scores indicate a larger impact of fatigue. | Will be answered before the test session in the patients home or during the test session | 
| Impact of MS on health | Self-assessed physical and psychological impact of MS on health. 29 items, rated from 1 to 5. Higher score indicates perceived worse physical or psychological impacts of MS, respectively, on health. | Will be answered before the test session in the patients home or during the test session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, brain activity, functional near infrared spectrometry, gait, physical activity