- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Erika Franzén, PhD
- Phone Number: +46852488878
- Email: erika.franzen@ki.se
Study Contact Backup
- Name: Compliance Office, -KI
- Phone Number: +46852480000
- Email: compliance@ki.se
Study Locations
-
-
Solna
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Stockholm, Solna, Sweden, 17177
- Recruiting
- Karolinska Institutet
-
Contact:
- Erika Franzén, PhD
- Phone Number: +46852488878
- Email: erika.franzen@ki.se
-
Principal Investigator:
- Erika Franzén, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multiple Sclerosis
People with Multiple Sclerosis, 18 years or older
|
Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During the test session during all three conditions
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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.
|
During the test session during all three conditions
|
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.
|
During the test session during complex walking condition 1 and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
During the test session, takes about 30 minutes
|
Physical activity level and intensity
Time Frame: For one week after the test session
|
Assessed with accelerometers (Actigraph GT3X+)
|
For one week after the test session
|
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
|
Will be answered before the test session in the patients home or during the test session
|
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
|
During the test session during dual task conditions
|
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
|
Will be answered before the test session in the patients home or during the test session
|
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.
|
During the test session, takes about 50 minutes
|
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).
|
During the test session, takes about 12 minutes
|
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).
|
During the test session, takes about 3 minutes
|
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)
|
During the test session, takes about 3 minutes
|
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).
|
During the test session, takes about 5 minutes
|
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)
|
Will be answered before the test session in the patients home or during the test session
|
Overall MS-disability
Time Frame: During the test session
|
Assessed with the Expanded Disability Status Scale (EDSS).
Higher scores=worse/more severe disability
|
During the test session
|
Balance performance
Time Frame: During the test session
|
Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p.
|
During the test session
|
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.
|
Will be answered before the test session in the patients home or at the test session
|
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.
|
Will be answered before the test session in the patients home or during the test session
|
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.
|
Will be answered before the test session in the patients home or during the test session
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erika Franzén, PhD9, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neurologic Manifestations
- Multiple Sclerosis
- Sclerosis
- Nervous System Diseases
- Neurodegenerative Diseases
- Gait Disorders, Neurologic
Other Study ID Numbers
- 4-1673/2020
- 2020-03059 (Ethical permit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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