Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06051877
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-09-18
Brief Title:
Ocular Microtremor in Parkinsons Disease
Sponsor:
Northumbria University
Organization:
Northumbria University
Study Overview
Official Title:
Ocular Microtremor in Parkinsons Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMTinPD
Brief Summary:
This is an exploratory observational study that will use a novel handheld device - The iTremor ONE which has been developed to rapidly non-invasively assess and evaluate OMT frequency This device uses incident laser technology directed at the sclera PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive motor using the UPDRS-III and OMT measures With OMT as the primary outcome assessment with the iTremor is incredibly quick taking just three seconds to obtain a reading PwPD will be assessed both off and on their anti-parkinsonian medication Off is defined as a 12Hr overnight washout period where participants are tested in the morning prior to their first dose PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance gait and turning using wearable sensors 40 PwPD 20 with suspected PD and 40 age-matched healthy control participants will be recruited for assessment of OMT Ten PwPD will complete a test-retest reliability assessment at the same approx time exactly one week after their initial visit
Detailed Description:
Ocular microtremor OMT is a fixational eye movement that cannot be seen with the naked eye but is always present even when the eye appears motionlessstill The link between OMT and brain function generates a strong rationale for investigation as there lies potential for its use as a biomarker in populations of neurological impairments OMT frequency is typically 70-80Hz in healthy adults and research suggests that this will be reduced in those with neurological disease such as Parkinsons Disease PD This study aims to examine OMT in people with PD PwPD compared to healthy older adults Identifying OMT as a PD biomarker could better support clinical assessment enabling improved provision of care to patients with advanced disease monitoring
This is an exploratory observational study that will use a novel handheld device - The iTremor ONE which has been developed to rapidly non-invasively assess and evaluate OMT frequency This device uses incident laser technology directed at the sclera PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive motor using the UPDRS-III and OMT measures With OMT as the primary outcome assessment with the iTremor is incredibly quick taking just three seconds to obtain a reading PwPD will be assessed both off and on their anti-parkinsonian medication PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance gait and turning using wearable sensors The Investigators will recruit 40 PwPD 20 suspected PD and 30 age-matched healthy control participants for assessment of OMT Ten PwPD will complete a test-retest reliability assessment at the same approx time exactly one week after their initial visit
This will be the first study of its kind to non-invasively investigate OMT frequency as a markermonitor for PD with advanced technology that could be used within the clinic laboratory or home
This is an exploratory observational study that will use a novel handheld device - The iTremor ONE which has been developed to rapidly non-invasively assess and evaluate OMT frequency This device uses incident laser technology directed at the sclera PwPD who meet the inclusion criteria will participate in a home-based assessment involving cognitive motor using the UPDRS-III and OMT measures With OMT as the primary outcome assessment with the iTremor is incredibly quick taking just three seconds to obtain a reading PwPD will be assessed both off and on their anti-parkinsonian medication PwPD will also be invited into the laboratory to perform extensive cognitive assessments along with an assessment of balance gait and turning using wearable sensors The Investigators will recruit 40 PwPD 20 suspected PD and 30 age-matched healthy control participants for assessment of OMT Ten PwPD will complete a test-retest reliability assessment at the same approx time exactly one week after their initial visit
This will be the first study of its kind to non-invasively investigate OMT frequency as a markermonitor for PD with advanced technology that could be used within the clinic laboratory or home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None