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Brain Activity During Gait in Parkinson's (BARC-PD)

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ClinicalTrials.gov Identifier: NCT04863560
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborators:
Parkinson's Foundation
Northumbria Healthcare NHS Foundation Trust
Information provided by (Responsible Party):
Northumbria University

Brief Summary:

Lay Summary:

Walking problems, such as slow and short steps, are very common in Parkinson's disease and lead to increased falls risk, as well as reduced mobility and quality of life. Walking issues are difficult to treat as medication interventions do not restore walking ability in people with Parkinson's, therefore physiotherapy approaches are used to help improve walking. Various physiotherapy strategies have been used, such as internal (thinking about bigger steps) or external prompts. External prompts include auditory (a metronome beat to step in time to), visual (lines to step over on the floor) and tactile (metronome-like vibration to step with) prompts that are very commonly used to improve walking in Parkinson's. However, the reason why walking improves in people with Parkinson's with these physiotherapy strategies is unknown, which has led to not all patients benefiting and only short-term walking improvements being seen.

The main issues are that it is unclear if these various internal or external prompt strategies are effective with the progression of Parkinson's disease, and it is unknown which type of strategy is most effective at different disease stages or with more severe walking impairment, such as freezing (the inability to progress walking for short periods despite wanting to do so). Being able to use specific brain regions to pay attention to different internal or external prompts has been suggested to be the reason why people with Parkinson's can overcome their walking problems, but this has not been tested. Therefore, this study will use state-of-the-art digital technology to measure walking and brain activity changes with different internal and external prompts. The investigators think that the walking improvement with different prompt strategies relies on the ability to activate specific brain regions, and that brain region activity in response to internal or external prompts will change at different stages of Parkinson's disease.

Ultimately, understanding the reasons why people benefit from these physiotherapy strategies and who benefits most from specific strategies will enable clinicians to provide more timely and efficient treatment for people with Parkinson's, and to develop more effective strategies to further improve walking.


Condition or disease Intervention/treatment
Parkinson Disease Other: Auditory Cueing Other: Visual Cueing Other: tactile Cueing

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Brain Activity Response to Cues During Gait in Parkinson's
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hoehn & Yahr stage I (H&YI)
- 20 Hoehn & Yahr stage I (early disease, minimal symptoms)
Other: Auditory Cueing
Metronome beat to step in time with

Other: Visual Cueing
Lines on the floor to step over

Other: tactile Cueing
Vibration to step in time with (metronome like)

Hoehn & Yahr stage II (H&YII)
- 30 Hoehn & Yahr stage II (mild disease, no balance issues)
Other: Auditory Cueing
Metronome beat to step in time with

Other: Visual Cueing
Lines on the floor to step over

Other: tactile Cueing
Vibration to step in time with (metronome like)

Hoehn & Yahr stage III (H&YIII)
- 30 Hoehn & Yahr stage III (moderate disease, balance issues)
Other: Auditory Cueing
Metronome beat to step in time with

Other: Visual Cueing
Lines on the floor to step over

Other: tactile Cueing
Vibration to step in time with (metronome like)




Primary Outcome Measures :
  1. Change in cortical oxygenated hemoglobin (HbO2) signal during walking [ Time Frame: immediately after intervention ]
    Change in cortical oxygenated hemoglobin (HbO2) measured while walking with cueing, which will be quantified with a wireless functional near infrared spectroscopy (fNIRS) system

  2. Change in cortical power spectral densities during walking [ Time Frame: immediately after intervention ]
    Change in cortical power spectral densities of EEG signals from cortex with cueing, which will be quantified with a mobile electroencephalography (EEG) system


Secondary Outcome Measures :
  1. Change in Stride Length (m) [ Time Frame: immediately after intervention ]
    Change in stride length with cueing

  2. Change in Gait Speed (m/s) [ Time Frame: immediately after intervention ]
    Change in speed of walking with cueing

  3. Change in Stride Time (s) [ Time Frame: immediately after intervention ]
    Change in time taken to complete a stride when walking with cues

  4. Change in Gait Variability (SD) [ Time Frame: immediately after intervention ]
    Change in variability (standard deviation; SD) of gait when walking with cues



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will involve 80 participants with PD, who will be split into groups dependent on the severity of their disease (classified with the Hoehn and Yahr (H&Y) scale); n=20 H&Y stage I (early disease, minimal symptoms); n=30 H&Y stage II (mild disease, no balance issues); n=30 H&Y stage III (moderate disease, balance issues).

Within the H&Y stage II and III groups, we will also ensure recruitment of a sub-group of n=15 individuals who self-report FOG within each group (n=30 total with FOG), which will provide a sub-group for further data analysis. We will limit FOG sub-group recruitment to these groups as we do not expect any individuals with FOG to be in H&Y stage I.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's by a movement disorder specialist according to United Kingdom (UK) brain bank criteria
  • Hoehn & Yahr (H&Y) stage I-III
  • Aged >50 years
  • Able to walk and stand unaided
  • Adequate hearing (as evaluated by the whisper test; stand 2m behind subject and whisper a 2 syllable word, subject repeats word) and vision capabilities (as measured using a Snellen chart - 6/18-6/12).
  • Stable medication for the past 1 month and anticipated over a period of 6 months

Exclusion Criteria:

  • Psychiatric co-morbidity (e.g., major depressive disorder as determined by Geriatric Depression Scale - short form (GDS-15); <10 [26])
  • Clinical diagnosis of dementia or other severe cognitive impairment (Montreal cognitive assessment <21 [27])
  • History of stroke, traumatic brain injury or other neurological disorders (other than PD, for the PD group)
  • Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
  • Unstable medical condition including cardio-vascular instability in the past 6 months
  • Unable to comply with the testing protocol or currently participating in another interfering research project
  • Interfering therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863560


Contacts
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Contact: Samuel Stuart, PhD 01912233343 sam.stuart@northumbria.ac.uk

Locations
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United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United Kingdom
Northumbria University Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7XA
Contact: Samuel Stuart, PhD    01912233343    sam.stuart@northumbria.ac.uk   
Contact: Rosie Morris, PhD       rosie.e.morris@northumbria.ac.uk   
Sub-Investigator: Julia Das         
Northumbria Healthcar NHS foundation trust Recruiting
North Shields, United Kingdom, NE29 8NH
Contact: Richard Walker    01912932709    richard.walker@northumbria-healthcare.nhs.uk   
Sponsors and Collaborators
Northumbria University
Parkinson's Foundation
Northumbria Healthcare NHS Foundation Trust
Investigators
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Principal Investigator: Samuel Stuart, PhD Northumbria University
  Study Documents (Full-Text)

Documents provided by Northumbria University:
Informed Consent Form  [PDF] September 17, 2020

Additional Information:
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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT04863560    
Other Study ID Numbers: PF-CRA-2073
286383 ( Other Identifier: IRAS )
20/LO/1036 ( Other Identifier: NHS Research Ethics Committee Reference )
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to the datasets can be obtained by contacting the principle investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
Parkison's disease
Gait
functional near infrared spectroscopy
electroencephalography
Inertial Sensors
Brain activity
Cueing
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases