Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-28 @ 9:46 AM
Study NCT ID:
NCT03517059
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease
Status:
COMPLETED
Status Verified Date:
2020-09
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:
Prodygi-II
Brief Summary:
Pilot study:
* Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
* Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
* Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations
* Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
* Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
* Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations
Detailed Description:
Prospective, clinical assessment of :
* Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition)
* Motor assessment using VICON gait and balance analysis
* Pulmonary functional testing in OFF and ON drug condition
* Quality of life
* Clinical neurological MDS UPDRS , N Fog questionnaire
* ENT and speech therapist evaluation in OFF and ON drug condition
* Cognition and diadochokinetic task during fMRI in 30 PD patients (in off and on condition)
* Motor assessment using VICON gait and balance analysis
* Pulmonary functional testing in OFF and ON drug condition
* Quality of life
* Clinical neurological MDS UPDRS , N Fog questionnaire
* ENT and speech therapist evaluation in OFF and ON drug condition
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-A01544-47 | OTHER | ID-RCB number, ANSM | View |