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

NCT05787704 | Completed

• 2 other identifiers: 4-1673/20202020-03059
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Cognitive function- composite score

  During the test session, takes about 50 minutes

• Cognitive function - verbal fluency

  During the test session, takes about 12 minutes

• Cognitive function - Attention and psychomotor processing speed

  During the test session, takes about 3 minutes

• Cognitive function - Episodic memory

  During the test session, takes about 30 minutes

• Cognitive function - Cognitive processing speed

  During the test session, takes about 3 minutes

Study Arms (1)

Multiple Sclerosis

People with Multiple Sclerosis, 18 years or older

Other: No intervention

Interventions

No intervention OTHER

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)

Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• with an MS diagnosis according to McDonald criteria
• with the ability to walk without a mobility device for ≥5 minutes continuously.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Solna, 17177, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Erika Franzén, PhD9

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: April 21, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 22, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: We plan to share this when applicable on OSF or similar
• Access Criteria: 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.

Locations

SE (1)