Prevalence of Orthostatic Tremor in Patients With Unsteadiness

Neuropathy Clinical Trial

— EMG-SOT  

Official title:

Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844203
• Other study ID #: APHP191089
• Secondary ID: 2019-A02976-51
• Status: Recruiting
• Start date: April 27, 2021
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nathalie KUBIS, MD, PhD
• Phone: +33149958108
• Email: nathalie.kubis[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuropathy
• Orthostatic Tremor
• Tremor

Intervention

Diagnostic Test:
• Polygraphy with surface electrodes
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

Locations

Country	Name	City	State
France	APHP Lariboisière Hospital, Clinical Physiology Department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of orthostatic tremor (OT	Prevalence of OT (95% confidence interval) in patients complaining of postural instability and referred for ENMG	Day 0
Secondary	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)	Day 0
Secondary	Medical Research Council (MRC) score	The MRC score grades muscle power on a scale of 0 (no detectable contraction) to 5 (normal force, comparable to the healthy side)	Day 0
Secondary	Overall Neuropathy Limitations Scale (ONLS) score	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)	Day 0
Secondary	Rasch-built Overall Disability Scale (R-ODS) score	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)	Day 0
Secondary	OT frequency	OT frequency in Hz	Day 0
Secondary	Motor unit number index (MUNIX)	MUNIX is a method for assessment of number of motor units using the compound muscle action potential (CMAP) and surface electromyographic interference pattern (SIP).	Day 0