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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05787704
Other study ID # 4-1673/2020
Secondary ID 2020-03059
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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