Prevalence of Orthostatic Tremor in Patients With Unsteadiness

Recruiting

• Conditions: Orthostatic Tremor; Neuropathy
• Interventions: Diagnostic Test: Polygraphy with surface electrodes

• Registration Number: NCT04844203
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2021-04-09
• Study First Submitted QC: 2021-04-09
• Study First Posted: 2021-04-14
• Study Start: 2021-04-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-01
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with unsteadiness	Polygraphy with surface electrodes	Patients with unsteadiness referred for an ENMG

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rasch-built Overall Disability Scale (R-ODS) score	Day 0	R-ODS scale comprising 24 items evaluates the ability to perform daily activities. The answers are rated on a scale of 0 to 48 (with 0 being very poor and 48 being best performance)
Medical Research Council (MRC) score	Day 0	The MRC score grades muscle power on a scale of 0 (no detectable contraction) to 5 (normal force, comparable to the healthy side)
Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified	Day 0	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)
Overall Neuropathy Limitations Scale (ONLS) score	Day 0	The ONLS score is be completed by adding the total of the Arm disability scale score (0-5) and Leg disability scale score (0-7) yielding a total score of 0-12 (higher score indicates higher disability)
OT frequency	Day 0	OT frequency in Hz
Motor unit number index (MUNIX)	Day 0	MUNIX is a method for assessment of number of motor units using the compound muscle action potential (CMAP) and surface electromyographic interference pattern (SIP).

Trial Locations

Locations (1)

APHP Lariboisière Hospital, Clinical Physiology Department; 🇫🇷 Paris, France