NeuropathyCANVASNCT05095870
Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS Neuropathies
An observational study of Neuropathy and Cerebellar Ataxia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Cerebellar Ataxia, Neurodegenerative Diseases
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients with CANVAS syndrome followed in our neurology department, using conventional electrophysiology and peripheral nerve ultrasound.
Who may be able to join
- Patients followed at the University Hospital of Nîmes between 2018-2021
- Age > 18 years
- Diagnosis of CANVAS with genetic evidence (RFC1+)
- Diagnosis of neuronopathy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS (Cerebellar Ataxia With Neuropathy and Vestibular Areflexia Syndrome) Neuronopathies
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.
Read more
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.
- Conditions
- Neuropathy, Cerebellar Ataxia, Neurodegenerative Diseases
- Being tested
- No intervention
- Medical subject headings
- Cerebellar Ataxia, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Pure observational study
| Study group | Role | What they receive |
|---|---|---|
| CANVAS Patients | Patient with a CANVAS diagnosis with genetic evidence (RFC1+) Receives: Other: No intervention | |
| control group | Patient with axonal sensory-motor or pure sensitive neuropathy confirmed by electroneuromyography Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
median ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of median nerve ultrasound
Measured: Baseline
ulnar nerve at wrist ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve at wrist, ultrasound
Measured: Baseline
mid-arm ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, mid-arm, ultrasound
Measured: Baseline
elbow ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, elbow, ultrasound
Measured: baseline
ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, mid-forearm, ultrasound
Measured: Day of the evaluation
radial nerve ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of radial nerve ultrasound
Measured: Baseline
superficial radial branch nerve ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of superficial radial branch nerve ultrasound
Measured: Baseline
C5, C6 ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of C5, C6 roots ultrasound
Measured: Baseline
sural nerve ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of sural nerve ultrasound
Measured: Baseline
superficial fibular nerve ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of superficial fibular nerve ultrasound
Measured: Baseline
popliteus ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of popliteus tibial nerve at ankle ultrasound
Measured: Baseline
tibial ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of tibial nerveat ankle ultrasound
Measured: Baseline
fibular ultrasound
Comparison of axial cross-sectional area to Bilateral exploration of fibular nerve at the neck ultrasound
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start25 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095870
- Sponsor's protocol ID
- LOCAL/2021/II-02
- Acronym
- CANVAS
- Status last verified
- May 2022
- First submitted
- 1 Oct 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Houjeiry E, Coudray S, Thouvenot E, Ion IM. Spinal cord lesion mimicking a dysimmune myelitis revealing CANVAS syndrome. J Spinal Cord Med. 2023 Mar;46(2):332-336. doi: 10.1080/10790268.2022.2033936. Epub 2022 Mar 2.
PubMed 35235501
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS (Cerebellar Ataxia With Neuropathy and Vestibular Areflexia Syndrome) Neuronopathies
- ClinicalTrials.gov ID
- NCT05095870
- Acronym / sponsor ID
- CANVAS / LOCAL/2021/II-02
- Conditions
- Neuropathy, Cerebellar Ataxia, Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CANVAS Patients | – | Other: No interventionPatient with a CANVAS diagnosis with genetic evidence (RFC1+) |
| control group | – | Other: No interventionPatient with axonal sensory-motor or pure sensitive neuropathy confirmed by electroneuromyography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients with CANVAS syndrome followed in our neurology department, using conventional electrophysiology and peripheral nerve ultrasound.
Key inclusion criteria (4 listed)
- Patients followed at the University Hospital of Nîmes between 2018-2021
- Age > 18 years
- Diagnosis of CANVAS with genetic evidence (RFC1+)
- Diagnosis of neuronopathy
Key exclusion criteria (4 listed)
- Age <18 years
- Chronic polyradiculoneuritis or other demyelinating neuropathy
- Patient with axonal sensory-motor or pure sensory neuropathy confirmed by electro neuromyography, and concordant with the clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionPure observational study | Other | CANVAS Patients, control group |
Primary outcome
median ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of median nerve ultrasound
ulnar nerve at wrist ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve at wrist, ultrasound
mid-arm ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, mid-arm, ultrasound
elbow ultrasound
Time frame: baseline
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, elbow, ultrasound
ultrasound
Time frame: Day of the evaluation
Comparison of axial cross-sectional area to Bilateral exploration of ulnar nerve, mid-forearm, ultrasound
radial nerve ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of radial nerve ultrasound
superficial radial branch nerve ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of superficial radial branch nerve ultrasound
C5, C6 ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of C5, C6 roots ultrasound
sural nerve ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of sural nerve ultrasound
superficial fibular nerve ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of superficial fibular nerve ultrasound
popliteus ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of popliteus tibial nerve at ankle ultrasound
tibial ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of tibial nerveat ankle ultrasound
fibular ultrasound
Time frame: Baseline
Comparison of axial cross-sectional area to Bilateral exploration of fibular nerve at the neck ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 35235501El Houjeiry E, Coudray S, Thouvenot E, Ion IM. Spinal cord lesion mimicking a dysimmune myelitis revealing CANVAS syndrome. J Spinal Cord Med. 2023 Mar;46(2):332-336. doi: 10.1080/10790268.2022.2033936. Epub 2022 Mar 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathy and Cerebellar Ataxia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median ultrasound (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.