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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787704
• Other study ID #: 4-1673/2020
• Secondary ID: 2020-03059
• Status: Recruiting
• Start date: April 21, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Compliance Office, -KI
• Phone: +46852480000
• Email: compliance[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Gait Disorders, Neurologic
• Multiple Sclerosis
• Nervous System Diseases
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Sclerosis

Intervention

Other:
• No intervention
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)

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Solna

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	During the test session, takes about 50 minutes
Secondary	Cognitive function - verbal fluency	Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System).	During the test session, takes about 12 minutes
Secondary	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).	During the test session, takes about 3 minutes
Secondary	Cognitive function - Episodic memory	Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).	During the test session, takes about 30 minutes
Secondary	Cognitive function - Cognitive processing speed	Cognitive processing speed will be assessed with the Symbol Digit Modalities Test (SDMT)	During the test session, takes about 3 minutes
Secondary	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).	During the test session, takes about 5 minutes
Secondary	Self-reported level of physical activity	Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)	Will be answered before the test session in the patients home or during the test session
Secondary	Physical activity level and intensity	Assessed with accelerometers (Actigraph GT3X+)	For one week after the test session
Secondary	Overall MS-disability	Assessed with the Expanded Disability Status Scale (EDSS). Higher scores=worse/more severe disability	During the test session
Secondary	Balance performance	Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p.	During the test session
Secondary	Anxiety and depression	Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better	Will be answered before the test session in the patients home or during the test session
Secondary	Walking ability	Self-assessed walking ability with the WALK-12G.	Will be answered before the test session in the patients home or at the test session
Secondary	Dual-task performance -errors	Cognitive performance of the dual task will be assessed as the reaction time to respond during Auditory stroop	During the test session during dual task conditions
Secondary	Disability	WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse	Will be answered before the test session in the patients home or during the test session
Secondary	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.	Will be answered before the test session in the patients home or during the test session
Secondary	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.	Will be answered before the test session in the patients home or during the test session