Prevalence of Orthostatic Tremor in Patients With Unstead... | NCT04844203

Studies
Prevalence of Orthostatic Tremor in Patients With Unsteadiness

NCT04844203

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jan 3, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Orthostatic Tremor
Neuropathy

Interventions

Polygraphy with surface electrodes

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A02976-51	Registry Identifier	IDRCB

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2021Actual

Primary Completion Date

Apr 2024Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Apr 9, 2021

First Submission Date that Met QC Criteria

Apr 9, 2021

First Posted Date

Apr 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2024

Last Update Posted Date

Jan 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with unsteadiness		Patients with unsteadiness referred for an ENMG	Diagnostic Test: Polygraphy with surface electrodes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polygraphy with surface electrodes	Diagnostic Test	Patients referred for ENMG to the Clinical Physiology Department and complaining of postural unsteadiness will undergo a polygraphy recording using surface electrodes (Natus Medical Incorporated), performed at the end of ENMG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of orthostatic tremor (OT	Prevalence of OT (95% confidence interval) in patients complaining of postural instability and referred for ENMG	Day 0

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified	The ISS ranges from 0 (normal sensation) to 20 (most severe sensory deficit) and is composed of the summation of the following sensation evaluations : pinprick arm grade (range 0-4) ; vibration arm grade (range 0-4) ; pinprick leg grade (range 0-4); vibration leg grade (range 0-4): two-point discrimination grade (range 0-4)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old
All patients complaining of instability when standing up and referred for an ENMG
Patient informed and having expressed his non-opposition to participating in the research

Exclusion Criteria:

Patient's refusal to participate in the study
Impossibility to stand
No affiliation to health insurance
Patients under a legal protection measure or unable to express their will
Patient under the State Medical Assistance (AME)
Patient under 18 years old
Pregnant women, parturients and breast-feeding mothers

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any patient referred to the Clinical physiology Department for an ENMG (investigation of the neuropathy)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nathalie KUBIS, MD, PhD	Contact	+33149958108		nathalie.kubis@aphp.fr
Pierre LOZERON, MD, PhD	Contact	+33149958076		pierre.lozeron@aphp.fr

Overall Officials

Name	Affiliation	Role
Nathalie KUBIS, MD, PhD	APHP, Lariboisière Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
APHP Lariboisière Hospital, Clinical Physiology Department	Recruiting	Paris		75010	France

Condition Browse Module

MeSH Terms

ID	Term
D014202	Tremor

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided