Prevalence of Orthostatic Tremor in Patients With Unsteadiness

NCT04844203 | Unknown

• 2 other identifiers: APHP1910892019-A02976-51
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Tremor; Neuropathy

Keywords

Electroneuromyography; Polygraphy; Unsteadiness; Tremor; Anti-MAG neuropathy; Chronic demyelinating inflammatory neuropathy

Outcome Measures

Primary Outcomes (1)

• Prevalence of orthostatic tremor (OT

  Prevalence of OT (95% confidence interval) in patients complaining of postural instability and referred for ENMG

  Day 0

Secondary Outcomes (6)

• Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified

  Day 0

• Medical Research Council (MRC) score

  Day 0

• Overall Neuropathy Limitations Scale (ONLS) score

  Day 0

• Rasch-built Overall Disability Scale (R-ODS) score

  Day 0

• OT frequency

  Day 0

Study Arms (1)

Patients with unsteadiness

Patients with unsteadiness referred for an ENMG

Diagnostic Test: Polygraphy with surface electrodes

Interventions

Polygraphy with surface electrodes 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

Patients with unsteadiness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient referred to the Clinical physiology Department for an ENMG (investigation of the neuropathy)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

APHP Lariboisière Hospital, Clinical Physiology Department

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie KUBIS, MD, PhD

  APHP, Lariboisière Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie KUBIS, MD, PhD

CONTACT

+33149958108; nathalie.kubis@aphp.fr

Pierre LOZERON, MD, PhD

CONTACT

+33149958076; pierre.lozeron@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 14, 2021
• Study Start: April 27, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

FR (1)