Clinical trial NCT05787704: Walking and Thinking - Brain Activity During Complex Walking in People With Multiple Sclerosis
Official title: Walking and Thinking - Brain Activity During Complex Walking in People With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Gait Disorders, Neurologic
Neuro-Degenerative Disease
Aging
Keywords: functional near infrared spectrometry
gait
physical activity
cognition
brain activity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2023-03-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are studying complex walking in four different populations, people with Multiple Sclerosis, healthy young adults, healthy elderly and elderly with Parkinson's disease. We have during 2022 completed data collection (ClinicalTrials.gov ID: NCT05218213) of healthy young adults, healthy elderly and elderly with Parkinson's disease. Hence, this registration concerns the MS cohort.

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Functional near infrared spectrometry (fNIRS)
timeFrame: During the test session during all three conditions
measure: Gait performance during all conditions
timeFrame: During the test session during all three conditions
measure: Dual-task performance-reaction time
timeFrame: During the test session during complex walking condition 1 and 3
Secondary outcomes:
measure: Cognitive function- composite score
timeFrame: During the test session, takes about 50 minutes
measure: Cognitive function - verbal fluency
timeFrame: During the test session, takes about 12 minutes
measure: Cognitive function - Attention and psychomotor processing speed
timeFrame: During the test session, takes about 3 minutes
measure: Cognitive function - Episodic memory
timeFrame: During the test session, takes about 30 minutes
measure: Cognitive function - Cognitive processing speed
timeFrame: During the test session, takes about 3 minutes
measure: Cognitive function - Inhibition & task-set switching
timeFrame: During the test session, takes about 5 minutes
measure: Self-reported level of physical activity
timeFrame: Will be answered before the test session in the patients home or during the test session
measure: Physical activity level and intensity
timeFrame: For one week after the test session
measure: Overall MS-disability
timeFrame: During the test session
measure: Balance performance
timeFrame: During the test session
measure: Anxiety and depression
timeFrame: Will be answered before the test session in the patients home or during the test session
measure: Walking ability
timeFrame: Will be answered before the test session in the patients home or at the test session
measure: Dual-task performance -errors
timeFrame: During the test session during dual task conditions
measure: Disability
timeFrame: Will be answered before the test session in the patients home or during the test session
measure: Impact of Fatigue
timeFrame: Will be answered before the test session in the patients home or during the test session
measure: Impact of MS on health
timeFrame: Will be answered before the test session in the patients home or during the test session
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Solna
Study officials:
affiliation: Karolinska Institutet
name: Erika Franzén, PhD9
role: PRINCIPAL_INVESTIGATOR
References: