Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06906276

Brain Activity During Complex Walking in People With 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gait Disorders, Neurologic Aging Atypical Parkinson Disease Nervous System Diseases Neurologic Manifestations Parkinson Disease, Familial, Type 1 Pathological Conditions, Signs and Symptoms Signs and Symptoms fNIRS

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Functional near infrared spectrometry (fNIRS)

    Time frame: Baseline

    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.

  2. Gait performance during all conditions

    Time frame: Baseline

    Gait variables such as stride time and/or velocity will be analyzed with the APDM mobility system.

  3. Dual-task performance-reaction time

    Time frame: Baseline

    Cognitive performance of the dual task will be assessed as errors in the response to the Auditory Stroop task.

Secondary outcomes

  1. Resting-state functional near infrared spectrometry (rsfNIRS)

    Time frame: Baseline

    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.

  2. Cognitive function- composite score

    Time frame: Baseline

    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.

  3. Cognitive function - verbal fluency

    Time frame: Baseline

    Verbal function, initiation & task-set switching with the Verbal Fluency test from D-KEFS (Delis-Kaplan Executive Function System).

  4. Cognitive function - Attention and psychomotor processing speed

    Time frame: Baseline

    Attention and psychomotor processing speed will be assessed with the Trail Making Test (TMT) from D-KEFS (Delis-Kaplan Executive Function System).

  5. Cognitive function - Episodic memory

    Time frame: Baseline

    Episodic memory will be assessed with the Ray Auditory Verbal Learning Test (RAVLT).

  6. Cognitive function - Inhibition & task-set switching

    Time frame: Baseline

    Inhibition & task-set switching with the Color-Word Interference Test (CWIT) from D-KEFS (Delis-Kaplan Executive Function System)

  7. Self-reported level of physical activity

    Time frame: Baseline

    Assessed with the Frändin-Grimby Scale (score 1-6, higher score=better)

  8. Physical activity

    Time frame: Baseline

    Assessed with accelerometers (Actigraph GT3X+) for seven consecutive days after the clinical visit

  9. Motor function/disease severity

    Time frame: Baseline

    Assessed with the movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Higher scores = worse/more symptoms

  10. Balance performance

    Time frame: Baseline

    Assessed with the Mini-BESTest (Balance Evaluation Systems test), 0-28p,

  11. Anxiety and depression

    Time frame: Baseline

    Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better

  12. Walking ability

    Time frame: Baseline

    Self-assessed walking ability with the WALK-12G.

  13. Dual-task performance -errors

    Time frame: Baseline

    Cognitive performance of the dual task will be assessed as the reaction time to respond during the Auditory Stroop

  14. Disability

    Time frame: Baseline

    WHO Disability Assessment Schedule (WHODAS) version 2.0, 12 self-assessed questions (12 to 60) more points=worse

Study contacts

Contact information is provided by the study sponsor or research team.

Compliance Office Karolinska Insitutet

CONTACT

[email protected]

+46852480000

Erika Franzén, Prof,

CONTACT

[email protected]

+46852488878

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.