Prevalence of Orthostatic Tremor in Patients With Unsteadiness
NCT ID: NCT04844203
Last Updated: 2024-01-03
Study Results
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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RECRUITING
100 participants
OBSERVATIONAL
2021-04-27
2024-04-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with unsteadiness
Patients with unsteadiness referred for an ENMG
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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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