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

April 23, 2021 updated by: Northumbria University

Brain Activity Response to Cues During Gait in Parkinson's

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hoehn & Yahr stage I (H&YI)
- 20 Hoehn & Yahr stage I (early disease, minimal symptoms)
Metronome beat to step in time with
Lines on the floor to step over
Vibration to step in time with (metronome like)
Hoehn & Yahr stage II (H&YII)
- 30 Hoehn & Yahr stage II (mild disease, no balance issues)
Metronome beat to step in time with
Lines on the floor to step over
Vibration to step in time with (metronome like)
Hoehn & Yahr stage III (H&YIII)
- 30 Hoehn & Yahr stage III (moderate disease, balance issues)
Metronome beat to step in time with
Lines on the floor to step over
Vibration to step in time with (metronome like)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediately after intervention
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
immediately after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Stride Length (m)
Time Frame: immediately after intervention
Change in stride length with cueing
immediately after intervention
Change in Gait Speed (m/s)
Time Frame: immediately after intervention
Change in speed of walking with cueing
immediately after intervention
Change in Stride Time (s)
Time Frame: immediately after intervention
Change in time taken to complete a stride when walking with cues
immediately after intervention
Change in Gait Variability (SD)
Time Frame: immediately after intervention
Change in variability (standard deviation; SD) of gait when walking with cues
immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Samuel Stuart, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Access to the datasets can be obtained by contacting the principle investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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