Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586320
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Quantification of Parkinsons Disease Patients as a Biomarker for Classification Prediction and Response to Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Mathematical Quantification of Limb and Eye Movements of Parkinsons Disease Patients as a Biomarker for Classification and Prediction of Disease State and Response to Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a three-armed open investigational study that aims to differentiate quantify and categorize abnormal eye movements and upper limbs movements in patients with Parkinsons disease The study is using investigational non-invasive devices for that reason including ANLIVA Hand Movement and ANLIVA Eye Movement
Detailed Description:
To evaluate performance of mathematical models developed to quantify and classify symptoms and disease state using sensor data from smart phone and eye tracking cameras in subjects with Parkinsons disease
A clinical investigator will be capturing data from the clinical encounter completed by default the same day in addition to other clinical questionnaires subjects will be filling themselves A percentage of subjects will be asked prior to their arrival to be part of a subset study called OFFON study where they will be asked not to take their IPD oral home medications prior to arrival Both study procedure elements will be performed at the beginning of the evaluation and 60 minutes after taking their medication There is also a longitudinal study part where a percentage of the subjects will be asked to visit the clinic with 6 months interval up to 4 times including the first visit There will be a percentage of approached subjects that belong to the category of Essential Tremor ET and Healthy control HC used for comparison purposes ET and HC subjects will undergo the same recruitment and testing process
A clinical investigator will be capturing data from the clinical encounter completed by default the same day in addition to other clinical questionnaires subjects will be filling themselves A percentage of subjects will be asked prior to their arrival to be part of a subset study called OFFON study where they will be asked not to take their IPD oral home medications prior to arrival Both study procedure elements will be performed at the beginning of the evaluation and 60 minutes after taking their medication There is also a longitudinal study part where a percentage of the subjects will be asked to visit the clinic with 6 months interval up to 4 times including the first visit There will be a percentage of approached subjects that belong to the category of Essential Tremor ET and Healthy control HC used for comparison purposes ET and HC subjects will undergo the same recruitment and testing process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None