Brain Activity During Complex Walking in People With Atypical Parkinsonian Syndromes

NCT06906276 | Recruiting

• 2 other identifiers: 4-2452/20242020-03059
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Disorders, Neurologic; Atypical Parkinson Disease; fNIRS; Aging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Resting-state functional near infrared spectrometry (rsfNIRS)

  Baseline

• Cognitive function- composite score

  Baseline

• Cognitive function - verbal fluency

  Baseline

• Cognitive function - Attention and psychomotor processing speed

  Baseline

• Cognitive function - Episodic memory

  Baseline

Study Arms (1)

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.

Interventions

Assessment of brain activity with fNIRS and behavioural assessments (motor, motor-cognitive and cognitive) during three complex walking conditions. OTHER

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)

Atypical Parkinsonian syndromes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Solna, Solna, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic; Parkinson Disease, Familial, Type 1

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Franziska Albrecht, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Erika Franzén, Prof,

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Compliance Office Karolinska Insitutet

CONTACT

+46852480000; compliance@ki.se

Erika Franzén, Prof,

CONTACT

+46852488878; erika.franzen@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Erika Franzén, RPT, PhD

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 2, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: We plan to share this when applicable on OSF
• 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.

Locations

SE (1)