Prevalence of Orthostatic Tremor in Patients With Unsteadiness

Last updated: January 1, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dystonia

Neuropathy

Treatment

Polygraphy with surface electrodes

Clinical Study ID

NCT04844203
APHP191089
2019-A02976-51
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theresearch

Exclusion

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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Polygraphy with surface electrodes
Phase:
Study Start date:
April 27, 2021
Estimated Completion Date:
April 30, 2024

Study 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).

Connect with a study center

  • APHP Lariboisière Hospital, Clinical Physiology Department

    Paris, 75010
    France

    Active - Recruiting

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