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Multiple SclerosisNCT05787704

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

An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
41 participants
Where
1 siteSweden
Study dates
21 Apr 2023to 22 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Disease or condition that affects cognition, gait or balance.
  • MS relapse or change of disease-modifying treatment within the past eight weeks.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm, Solna, 17177

Other trials in Sweden

About this study

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).

Being tested
No intervention
Keywords
functional near infrared spectrometry, gait, physical activity, cognition, brain activity
Medical subject headings
Multiple Sclerosis, Gait Disorders, Neurologic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    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)
Study groups in NCT05787704
Study groupRoleWhat they receive
Multiple SclerosisPeople with Multiple Sclerosis, 18 years or older
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the test session during all three conditions

  2. Gait performance during all conditions

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

    Measured: During the test session during all three conditions

  3. Dual-task performance-reaction time

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

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

Secondary outcomes (16)

  1. 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.

    Measured: During the test session, takes about 50 minutes

  2. Cognitive function - verbal fluency

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

    Measured: During the test session, takes about 12 minutes

  3. 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).

    Measured: During the test session, takes about 3 minutes

  4. Cognitive function - Episodic memory

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

    Measured: During the test session, takes about 30 minutes

  5. Cognitive function - Cognitive processing speed

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

    Measured: During the test session, takes about 3 minutes

  6. 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).

    Measured: During the test session, takes about 5 minutes

  7. Self-reported level of physical activity

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

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

  8. Physical activity level and intensity

    Assessed with accelerometers (Actigraph GT3X+)

    Measured: For one week after the test session

  9. Overall MS-disability

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

    Measured: During the test session

  10. Balance performance

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

    Measured: During the test session

  11. Anxiety and depression

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

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

  12. Walking ability

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

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

  13. Dual-task performance -errors

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

    Measured: During the test session during dual task conditions

  14. Disability

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

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

  15. 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.

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

  16. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start21 Apr 2023
  3. Primary completion14 May 2024
  4. Study completion22 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787704
Sponsor's protocol ID
4-1673/2020
Other IDs
2020-03059
Status last verified
Oct 2024
First submitted
15 Mar 2023
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional near infrared spectrometry (fNIRS) (time frame: During the test session during all three conditions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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