Prevalence of Orthostatic Tremor in Patients With Unsteadiness

NCT ID: NCT04844203

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-27

Study Completion Date

2024-04-30

Brief Summary

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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

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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).

Conditions

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Orthostatic Tremor Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with unsteadiness

Patients with unsteadiness referred for an ENMG

Polygraphy with surface electrodes

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie KUBIS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP, Lariboisière Hospital

Locations

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APHP Lariboisière Hospital, Clinical Physiology Department

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nathalie KUBIS, MD, PhD

Role: CONTACT

+33149958108

Pierre LOZERON, MD, PhD

Role: CONTACT

+33149958076

Facility Contacts

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Nathalie KUBIS, MD, PhD

Role: primary

+33149958108

Pierre LOZERON, MD, PhD

Role: backup

+33149958076

Other Identifiers

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2019-A02976-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP191089

Identifier Type: -

Identifier Source: org_study_id

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