Prevalence of Orthostatic Tremor in Patients With Unsteadiness (EMG-SOT)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Orthostatic Tremor; Neuropathy

Treatments: Diagnostic Test: Polygraphy with surface electrodes

Study type: Observational

Funder types: Other

Identifiers

NCT04844203

2019-A02976-51 (Registry Identifier)

APHP191089

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patients with unsteadiness

Description:

Patients with unsteadiness referred for an ENMG

Treatment:

Diagnostic Test: Polygraphy with surface electrodes