At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- gait with cueing wearable device and neuro-ocular performance (device)
- How long the study runs
- Study runs about 16 months (dates as stated)
- About the drug or intervention
- gait with cueing wearable device and neuro-ocular performance — device: Participants will be invited to participate in the following sequential phases.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 80
- Started
- 2024-12-20
- Last checked
- 2025-01
Plain English Summary
What is this study?
- • Testing a new treatment for healthy controls
- • NA - 80 participants
- • In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with healthy controls
Where?
- • Exeter - University of Exeter
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD. With this, the investigators aim to advance the state of the art in PD diagnosis and monitoring. By integrating the principles of machine learning with high-quality sensor data, more accurate and earlier diagnosis could potentially be achieved. Ocular motor and pupil data will be collected with the standard clinical examination and with neos, a medical device approved for objective ocular motor and pupil measurement. Gait will be collected using an IMU sensor and GaitQ senti, a consumer device that allows for an objective and continuous remote gait monitoring.
More detail
Parkinson's disease (PD) is one of the most common neurodegenerative diseases worldwide, affecting 1% of the population older than 65. Currently, PD diagnosis is based on history, clinical assessments, and neurological examination. The most widely used criteria for diagnosis are the Movement Disorder Society (MDS) criteria and instrument (i.e. The MDS-UPDRS). Further information may be gained from people's subjective description of their symptoms and/or via some short walking tests, such as 3-meter Timed Up and Go (TUG) performed as a snapshot in the clinic. However, people's symptoms vary through and between days and subjective descriptions rely on their memory and observations at home. These recollections can be unreliable or lack enough detail (particularly when the person has cognitive impairment). Therefore, current PD diagnosis criteria are highly dependent on the person and on the diagnosing physician. This subjectivity may lead to a variability in the diagnosis. Furthermore, these clinical assessments are unable to accurately track disease progression over time, making it difficult to provide personalized care. Additionally, manual examinations lack precise measurement instruments, resulting in a low precision of observed measurements and the inability to detect early-stage, subclinical signs. An objective diagnosis based on quantitative data rather than subjective interpretation of clinical findings is important. Therefore, an early and accurate diagnosis of PD, as well as accurate disease progression monitoring, are still important challenges in PD. Several oculo-visual abnormalities have been described in PD. Studies report an abnormal ocular motor function in 75-87.5% of people with PD. These dysfunctions may precede or follow motor symptoms and thus, the evaluation of ocular motor function may provide valuable information regarding early disease detection or disease progression. The most commonly reported ocular motor dysfunctions are impairments in saccades, smooth pursuit, and vergence. Gait impairments are among the most common and disabling symptoms of PD. Gait impairments include freezing of gait (FOG), an inability to initiate or maintain normal walking patterns, often resulting in a stochastic stop/start gait, and festinating gait (FSG), which is a shortening of stride length with elevated step frequency, resulting in fast, shuffling steps. Both FOG and FSG contribute to an increased risk of falls (and fall-related injuries) in people with PD relative to the wider elderly population. Objective, and continuous remote gait monitoring would be highly important in people with PD, to objectively track gait impairments in real-time, and potentially contribute to objectively track disease progression, which may lead to personalized care for individuals with PD. In this project, ocular motor, pupil and gait data in people with Parkinson's disease (PD) will be collected in order to develop machine learning models for the diagnosis and monitoring of PD. With this, the investigators aim to advance the state of the art in PD diagnosis and monitoring. By integrating the principles of machine learning with high-quality sensor data, more accurate and earlier diagnosis could potentially be achieved. Ocular motor and pupil data will be collected with the standard clinical examination and with neos, a medical device approved for objective ocular motor and pupil measurement. Gait will be collected using an IMU sensor and GaitQ senti, a consumer device that allows for an objective and continuous remote gait monitoring. The primary objective of this project is to collect ocular motor, pupil and gait data from people with PD in order to develop and compare machine learning models for diagnosing and monitoring PD. Secondary objectives are: Correlate ocular motor, pupil and gait parameters with several clinical parameters, including the MDS-UPDRS. Collect real-world evidence (RWE) data regarding health economics parameters to address the individual and combined properties, effects, and/or impacts of the deployed health technologies. By analysing the data collected, we also aim to contribute to the scientific understanding of PD, potentially uncovering new insights into disease patterns, progression, and response to treatments.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Inclusion criteria Participants with Parkinson's \[Phase 1,2,3,4\]
- ✓Diagnosis of idiopathic Parkinson's disease (UK Brain Bank Criteria) or other appropriate condition specific scale...
- ✓Able to self-report history of daily gait freezing and/or festination for people with PD or gait and/or transfers...
- ✓Able to walk unsupported or using an aid for at least 5 minutes and satisfactory completion of the Canadian PARQ and...
- ✓Adult (+18 years old)
See the full criteria
Where Is This Study? (1 UK site)
University of Exeter
Exeter EX1 2LU, United Kingdom
How to Get in Touch
Pavlos Evangelidis, PhD
Sponsor contactCONTACT
Helen Dawes, PhD
Sponsor contactCONTACT
