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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05095870
Other study ID # LOCAL/2021/II-02
Secondary ID IRB 21.09.30
Status Completed
Phase
First received
Last updated
Start date October 25, 2021
Est. completion date March 30, 2022

Study information

Verified date May 2022
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cerebellar ataxia with neuropathy and bilateral areflexia syndrome (CANVAS) is a late onset neurodegenerative disorder with a slowly progressive ataxia. It's genetic causative etiology with an autosomal recessive inheritance has a recent discovery. It is clinically characterized by impaired visually enhanced vestibulo-ocular reflex, although patients commonly present with imbalance as a main concern, associated with sensory complaints. It has been demonstrated that sensory impairment in CANVAS patients is due to degeneration of dorsal root with abnormal sensory nerve conduction. Previously defined diagnostic criteria included cerebellar atrophy on brain MRI, neuronopathy on electrophysiological studies and negative genetic testing for other inherited ataxia syndromes like Friedriech ataxia and spinal cerebellar ataxia (SCA). Peripheral nerve ultrasound is a noninvasive technique, able to identify abnormal peripheral nerves with underlying injuries and specific sonographic characteristics. Pelosi et al established that patients with CANVAS have a smaller nerve cross sectional area (CSA) compared to healthy individuals and/ or axonal neuropathies. The main objective of this study was to obtaine a detailed description of peripheral nerves in consecutive patients with CANVAS syndrome followed in theneurology department of the Universitary Hospital of Nimes (France), using conventional electrophysiology and peripheral nerve ultrasound.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility CANVAS Patients : Inclusion Criteria: - Patients followed at the University Hospital of Nîmes between 2018-2021 - Age > 18 years - Diagnosis of CANVAS with genetic evidence (RFC1+) - Diagnosis of neuronopathy Exclusion Criteria: - Age <18 years - Chronic polyradiculoneuritis or other demyelinating neuropathy Control group, inclusion criteria : Patient with axonal sensory-motor or pure sensory neuropathy confirmed by electro neuromyography, and concordant with the clinic.

Study Design


Intervention

Other:
No intervention
Pure observational study

Locations

Country Name City State
France CHU de Nîmes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary median ultrasound Comparison of axial cross-sectional area to Bilateral exploration of median nerve ultrasound Baseline
Primary ulnar nerve at wrist ultrasound Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve at wrist, ultrasound Baseline
Primary mid-arm ultrasound Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, mid-arm, ultrasound Baseline
Primary elbow ultrasound Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, elbow, ultrasound baseline
Primary ultrasound Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, mid-forearm, ultrasound Day of the evaluation
Primary radial nerve ultrasound Comparison of axial cross-sectional area to Bilateral exploration of radial nerve ultrasound Baseline
Primary superficial radial branch nerve ultrasound Comparison of axial cross-sectional area to Bilateral exploration of superficial radial branch nerve ultrasound Baseline
Primary C5, C6 ultrasound Comparison of axial cross-sectional area to Bilateral exploration of C5, C6 roots ultrasound Baseline
Primary sural nerve ultrasound Comparison of axial cross-sectional area to Bilateral exploration of sural nerve ultrasound Baseline
Primary superficial fibular nerve ultrasound Comparison of axial cross-sectional area to Bilateral exploration of superficial fibular nerve ultrasound Baseline
Primary popliteus ultrasound Comparison of axial cross-sectional area to Bilateral exploration of popliteus tibial nerve at ankle ultrasound Baseline
Primary tibial ultrasound Comparison of axial cross-sectional area to Bilateral exploration of tibial nerveat ankle ultrasound Baseline
Primary fibular ultrasound Comparison of axial cross-sectional area to Bilateral exploration of fibular nerve at the neck ultrasound Baseline
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