Clinical trial NCT06906276: Brain Activity During Complex Walking in People With Atypical Parkinsonian Syndromes
Official title: Walking and Thinking - Brain Activity During Complex Walking in Atypical Parkinsonian Syndromes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gait Disorders, Neurologic
Atypical Parkinson Disease
fNIRS
Aging
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2025-04-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are studying complex walking in different populations, such as 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. In 2024, we completed data collection in people with Multiple Sclerosis (NCT05787704).

Hence, this registration concerns the atypical parkinsonism cohort.

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 atypical Parkinson's disease (APD) 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 ecologically valid state. The investigators aim therefore to explore brain function during complex walking in healthy and APD 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 older healthy adults and people with APD.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of PSP according to Movement Disorder Society (MDS) (2017) or
* MSA according to MDS criteria (2022)
* the ability to walk with or without a mobility device for ≤5 minutes continuously

Exclusion Criteria:

* cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions
* severe freezing of gait
* Severe hearing or visual impairments that affect participation in the assessments
* Other neurological diseases
* Other diseases that can affect gait or balance.

Primary outcomes:
measure: Functional near infrared spectrometry (fNIRS)
timeFrame: Baseline
measure: Gait performance during all conditions
timeFrame: Baseline
measure: Dual-task performance-reaction time
timeFrame: Baseline
Secondary outcomes:
measure: Resting-state functional near infrared spectrometry (rsfNIRS)
timeFrame: Baseline
measure: Cognitive function- composite score
timeFrame: Baseline
measure: Cognitive function - verbal fluency
timeFrame: Baseline
measure: Cognitive function - Attention and psychomotor processing speed
timeFrame: Baseline
measure: Cognitive function - Episodic memory
timeFrame: Baseline
measure: Cognitive function - Inhibition & task-set switching
timeFrame: Baseline
measure: Self-reported level of physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: Baseline
measure: Motor function/disease severity
timeFrame: Baseline
measure: Balance performance
timeFrame: Baseline
measure: Anxiety and depression
timeFrame: Baseline
measure: Walking ability
timeFrame: Baseline
measure: Dual-task performance -errors
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Franziska Albrecht, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Erika Franzén, Prof,
role: PRINCIPAL_INVESTIGATOR
References: