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NCT Number: NCT05787704

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

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).

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Key information

Conditions

Multiple Sclerosis Aging Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Gait Disorders, Neurologic Immune System Diseases Motor Activity Nervous System Diseases Neuro-Degenerative Disease Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Solna, 17177, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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)

Primary outcomes

  1. Functional near infrared spectrometry (fNIRS)

    Time frame: During the test session during all three conditions

    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.

  2. Gait performance during all conditions

    Time frame: During the test session during all three conditions

    Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.

  3. Dual-task performance-reaction time

    Time frame: During the test session during complex walking condition 1 and 3

    Cognitive performance of the dual task will be assessed as errors in the response to the Auditory stroop task.

Secondary outcomes

  1. Cognitive function- composite score

    Time frame: During the test session, takes about 50 minutes

    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.

  2. Cognitive function - verbal fluency

    Time frame: During the test session, takes about 12 minutes

    Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System).

  3. Cognitive function - Attention and psychomotor processing speed

    Time frame: During the test session, takes about 3 minutes

    Attention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System).

  4. Cognitive function - Episodic memory

    Time frame: During the test session, takes about 30 minutes

    Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).

  5. Cognitive function - Cognitive processing speed

    Time frame: During the test session, takes about 3 minutes

    Cognitive processing speed will be assessed with the Symbol Digit Modalities Test (SDMT)

  6. Cognitive function - Inhibition & task-set switching

    Time frame: During the test session, takes about 5 minutes

    Inhibition & task-set switching with the The Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System).

  7. Self-reported level of physical activity

    Time frame: Will be answered before the test session in the patients home or during the test session

    Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)

  8. Physical activity level and intensity

    Time frame: For one week after the test session

    Assessed with accelerometers (Actigraph GT3X+)

  9. Overall MS-disability

    Time frame: During the test session

    Assessed with the Expanded Disability Status Scale (EDSS). Higher scores=worse/more severe disability

  10. Balance performance

    Time frame: During the test session

    Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p.

  11. Anxiety and depression

    Time frame: Will be answered before the test session in the patients home or during the test session

    Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better

  12. Walking ability

    Time frame: Will be answered before the test session in the patients home or at the test session

    Self-assessed walking ability with the WALK-12G.

  13. Dual-task performance -errors

    Time frame: During the test session during dual task conditions

    Cognitive performance of the dual task will be assessed as the reaction time to respond during Auditory stroop

  14. Disability

    Time frame: Will be answered before the test session in the patients home or during the test session

    WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse

  15. Impact of Fatigue

    Time frame: Will be answered before the test session in the patients home or during the test session

    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.

  16. Impact of MS on health

    Time frame: Will be answered before the test session in the patients home or during the test session

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2023
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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