Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04844203
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2021-04-09
Brief Title:
Prevalence of Orthostatic Tremor in Patients With Unsteadiness
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness
Status:
RECRUITING
Status Verified Date:
2024-01
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:
EMG-SOT
Brief Summary:
Clinical presentation of orthostatic tremor OT may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies In addition peripheral neuropathies represent the leading cause of pathologies associated with OT Among patients referred for an electroneuromyogram ENMG for peripheral neuropathy and presenting with postural unsteadiness OT assessment will be systematically performed Demographic clinical and polygraphy characteristics of these patients will be analyzed and prevalence of OT in the general population of peripheral neuropathies will be assessed
Detailed Description:
Among patients who will be referred for ENMG and exploration of a neuropathy orthostatic tremor will be investigated systematically
Main objective and primary endpoint
To estimate the prevalence of OT with its 95 confidence interval in the population of patients defined above
Presence of OT confirmed by surface EMG polygraphy in patients with standing instability referred for ENMG
Secondary objectives and end points
Determine the demographic clinical electrophysiological characteristics of patients with OT Estimate the prevalence of peripheral neuropathy in patients with OT Duration of symptoms Correlation with quantitative neuropathy scores ISS MRC ONLS R-ODS
Age sex clinical parameters symptoms reported by the patient instability tremor weakness pain falls duration current medications ISS score MRC score ONLS score R-ODS score and electrophysiological parameters mean frequency of OT in Hertz MUNIX score number of motor units in the anterior tibialis calculated by software on the ENMG machine
Main objective and primary endpoint
To estimate the prevalence of OT with its 95 confidence interval in the population of patients defined above
Presence of OT confirmed by surface EMG polygraphy in patients with standing instability referred for ENMG
Secondary objectives and end points
Determine the demographic clinical electrophysiological characteristics of patients with OT Estimate the prevalence of peripheral neuropathy in patients with OT Duration of symptoms Correlation with quantitative neuropathy scores ISS MRC ONLS R-ODS
Age sex clinical parameters symptoms reported by the patient instability tremor weakness pain falls duration current medications ISS score MRC score ONLS score R-ODS score and electrophysiological parameters mean frequency of OT in Hertz MUNIX score number of motor units in the anterior tibialis calculated by software on the ENMG machine
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02976-51 | REGISTRY | IDRCB | None |