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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05787704
Enrollment
41
Registered
2023-03-28
Start date
2023-04-21
Completion date
2024-05-22
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

functional near infrared spectrometry, gait, physical activity, cognition, brain activity

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).

Interventions

OTHERNo intervention

Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions. 1. Dual-task walking with the auditory stroop task. 2. Navigational walking - a course consisting of a distribution of 45 and 90 degrees turns to the left and right 3. Navigational and dual-task walking (condition 1 and 2 together)

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional near infrared spectrometry (fNIRS)During the test session during all three conditionsThe 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.
Gait performance during all conditionsDuring the test session during all three conditionsGait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.
Dual-task performance-reaction timeDuring the test session during complex walking condition 1 and 3Cognitive performance of the dual task will be assessed as errors in the response to the Auditory stroop task.

Secondary

MeasureTime frameDescription
Cognitive function - Episodic memoryDuring the test session, takes about 30 minutesEpisodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).
Cognitive function - Cognitive processing speedDuring the test session, takes about 3 minutesCognitive processing speed will be assessed with the Symbol Digit Modalities Test (SDMT)
Cognitive function - Inhibition & task-set switchingDuring the test session, takes about 5 minutesInhibition & task-set switching with the The Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System).
Self-reported level of physical activityWill be answered before the test session in the patients home or during the test sessionAssessed with the Frändin-Grimby Scale (score 1-6, higher score=better)
Physical activity level and intensityFor one week after the test sessionAssessed with accelerometers (Actigraph GT3X+)
Overall MS-disabilityDuring the test sessionAssessed with the Expanded Disability Status Scale (EDSS). Higher scores=worse/more severe disability
Cognitive function- composite scoreDuring the test session, takes about 50 minutesThe 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.
Anxiety and depressionWill be answered before the test session in the patients home or during the test sessionAssessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better
Walking abilityWill be answered before the test session in the patients home or at the test sessionSelf-assessed walking ability with the WALK-12G.
Dual-task performance -errorsDuring the test session during dual task conditionsCognitive performance of the dual task will be assessed as the reaction time to respond during Auditory stroop
DisabilityWill be answered before the test session in the patients home or during the test sessionWHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse
Impact of FatigueWill be answered before the test session in the patients home or during the test sessionSelf-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.
Impact of MS on healthWill be answered before the test session in the patients home or during the test sessionSelf-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.
Balance performanceDuring the test sessionAssessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p.
Cognitive function - verbal fluencyDuring the test session, takes about 12 minutesVerbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System).
Cognitive function - Attention and psychomotor processing speedDuring the test session, takes about 3 minutesAttention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026