Brain Activity During Complex Walking in People With Atypical Parkinsonian Syndromes

Walking and Thinking - Brain Activity During Complex Walking in Atypical Parkinsonian Syndromes

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Gait Disorders, Neurologic; Atypical Parkinson Disease; fNIRS
• Intervention / Treatment: Other: Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Compliance Office Karolinska Insitutet; Phone Number: +46852480000; Email: compliance@ki.se
• Study Contact Backup: Name: Erika Franzén, Prof,; Phone Number: +46852488878; Email: erika.franzen@ki.se

Study Locations

• Sweden
  • Solna, Sweden, 17177
    • Recruiting
    • Karolinska Institutet
    • Contact: Erika Franzén; Phone Number: 0046737121593; Email: erika.franzen@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atypical Parkinsonian syndromes; -People with either Progressive supranuclear palsy or Multiple system atrophy	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Gait performance during all conditions	Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.	Baseline
Dual-task performance-reaction time	Cognitive performance of the dual task will be assessed as errors in the response to the Auditory Stroop task.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression	Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better	Baseline
Resting-state functional near infrared spectrometry (rsfNIRS)	The measurement of changes in concentration of HbO and HHb in the whole cortex will be assessed using a NIRSPORT 2 (NIRx Medizintechnik, Berlin, Germany) device during 2x 10min of rest, while seated in a comfortable chair.	Baseline
Cognitive function- composite score	The cognitive test battery comprised the following tests: The Color-Word Interference Test (CWIT), Verbal Fluency, Trail Making Test (TMT), Ray Auditory Verbal Learning Test (RAVLT), and Symbol Digit Modalities Test (SDMT). Cognitive function will be assessed as a composite measure of these tests together.	Baseline
Cognitive function - verbal fluency	Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System).	Baseline
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).	Baseline
Cognitive function - Episodic memory	Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).	Baseline
Cognitive function - Inhibition & task-set switching	Inhibition & task-set switching with the Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System)	Baseline
Self-reported level of physical activity	Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)	Baseline
Physical activity	Assessed with accelerometers (Actigraph GT3X+) for seven consecutive days after the clinical visit	Baseline
Motor function/disease severity	Assessed with the movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Higher scores = worse/more symptoms	Baseline
Balance performance	Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p,	Baseline
Walking ability	Self-assessed walking ability with the WALK-12G.	Baseline
Dual-task performance -errors	Cognitive performance of the dual task will be assessed as the reaction time to respond during the Auditory Stroop	Baseline
Disability	WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse	Baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Franziska Albrecht, PhD, Karolinska Institutet; Principal Investigator: Erika Franzén, Prof,, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Basal Ganglia Diseases; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic; Parkinsonian Disorders
• Other Study ID Numbers: 4-2452/2024; 2020-03059 (Other Identifier: other Study ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient, provided that the recipient has an approved ethics application.
• IPD Sharing Time Frame: We plan to share this when applicable on OSF
• IPD Sharing Access Criteria: The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request. Any sharing of data will be regulated via a data transfer and user agreement with the recipient.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No