Clinical trial NCT04844203: Prevalence of Orthostatic Tremor in Patients With Unsteadiness
Official title: Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthostatic Tremor
Neuropathy
Keywords: Electroneuromyography
Polygraphy
Unsteadiness
Tremor
Anti-MAG neuropathy
Chronic demyelinating inflammatory neuropathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient referred to the Clinical physiology Department for an ENMG (investigation of the neuropathy)

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).

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

Primary outcomes:
measure: Prevalence of orthostatic tremor (OT
timeFrame: Day 0
Secondary outcomes:
measure: Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified
timeFrame: Day 0
measure: Medical Research Council (MRC) score
timeFrame: Day 0
measure: Overall Neuropathy Limitations Scale (ONLS) score
timeFrame: Day 0
measure: Rasch-built Overall Disability Scale (R-ODS) score
timeFrame: Day 0
measure: OT frequency
timeFrame: Day 0
measure: Motor unit number index (MUNIX)
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Lariboisière Hospital, Clinical Physiology Department
Study officials:
affiliation: APHP, Lariboisière Hospital
name: Nathalie KUBIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: