Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease

Parkinson Disease Clinical Trial

— ParkMOVE  

Official title:

Walking and Thinking - Brain Activity During Complex Walking in Aging and Parkinson's Disease (Part of the ParkMOVE Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218213
• Other study ID #: 2020-03059
• Status: Recruiting
• Start date: January 21, 2022
• Est. completion date: July 1, 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 Parkinson's disease (PD) 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 healthy and PD by investigating the effects of age and 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 young, older healthy adults and people with PD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Healthy young:

Inclusion criteria:

-18 to 50 years

Exclusion criteria:

• Disease or condition that affects cognition, gait or balance.
• Severe hearing or visual impairments that affects participation in the assessments Healthy elderly:

Inclusion criteria:

• =60 years of age,
• 23 or more on the Montreal Cognitive Assessment (MoCA)

Exclusion criteria:

• Disease or condition that affects gait or balance.
• Severe hearing or visual impairments that affects participation in the assessments Parkinson cohort:

Inclusion criteria:

• =60 years of age
• a clinical diagnosis of PD=6 months prior to enrollment
• with the ability to walk without a mobility device for =5 minutes continuously.

Exclusion criteria:

• People with speech difficulties (e.g. aphasia)
• cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions
• severe freezing of gait
• Severe hearing or visual impairments that affects participation in the assessments
• Other neurological diseases
• Other disease that can affect gait or balance.

Related Conditions & MeSH terms

• Aging
• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

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 dual task conditions
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). 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 - 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)	Through study completion, an average of 1 year
Secondary	Physical activity level and intensity	Assessed with accelerometers (Actigraph GT3X+)	For one week after the test session
Secondary	Motor function/disease severity	Assessed with the movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Higher scores = worse/more symptoms	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