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NCT Number: NCT07651540

Clinical Evaluation of Sensory Neuronopathies: the Neuronoscore Study

Sensory neuronopathies (SN) are a group of rare neuropathies characterized by selective destruction of sensory neurons located in the dorsal root ganglia. SN may result from a wide range of etiologies, particularly paraneoplastic, autoimmune, toxic, and genetic causes. The functional prognosis of patients with SN is generally poor: in a recent study, two-thirds of patients had a modified Rankin Scale (mRS) score ≥3 and nearly half had an mRS ≥4.

The absence of reliable biomarkers in neuropathies justifies the use of clinical scales as indicators of disease severity, disability, and treatment response. However, none of the currently available "general neuropathy" scales have been specifically designed or validated for SN. The only scale developed specifically for SN is the SEARS (Sensory Ataxia Rating Scale), proposed in 2019, but it has not been widely used nor validated in large populations.

As a result, the absence of a clinical scale specifically designed for patients with SN makes longitudinal follow-up more challenging, particularly when assessing the response to immunomodulatory or immunosuppressive treatments when these therapies are indicated.

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Key information

Conditions

Sensory Neuronopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu D Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient affiliated with or beneficiary of a social security system
  • Patient having received appropriate study information
  • Adult patient ≥18 years old, male or female
  • Patient diagnosed with probable SN according to Camdessanché et al. diagnostic criteria
  • SN with one of the following etiologies:

Paraneoplastic SN with anti-Hu or anti-CV2/CRMP5 antibodies SN associated with Sjögren's syndrome, systemic lupus erythematosus, or primary biliary cholangitis Platinum-salt-induced SN SN caused by CANVAS syndrome

Exclusion criteria

  • Patient unable to understand or read French
  • Patient refusal to participate
  • Patient known to have another neuropathy phenotype and/or etiology that could significantly influence clinical scales and electrophysiological parameters, including:
  • Diabetes mellitus
  • Significant alcohol consumption
  • Severe chronic kidney disease (GFR <30 ml/min)
  • Vitamin B12 and/or vitamin E deficiency
  • Vitamin B6 excess
  • Chemotherapy other than platinum salts
  • HIV infection

Treatment and study plan

Longitudinal monitoring of clinical assessment scores to identify the most appropriate tool for tracking disease progression in sensory neuronopathies.

Other

After patient consent, three follow-up visits (T0, T6, T12) will be scheduled. Some information will already be collected at baseline (demographics, medical history, comorbidities). Three visits will be conducted: (T0), Follow-up at 6 months (T6), Follow-up at 12 months (T12)

At each visit the following will be assessed:

Clinical scales: mISS, SEARS, CADT, SARA, ONLS, I-RODS, 9-Hole Peg Test, Timed Up and Go test, mRS, Quantified Rydel tuning fork test, Visual Analog Scale (VAS) ENMG including sensory nerve action potentials of the radial and sural nerves (antidromic recording

Primary outcomes

  1. The Clinical Global Impression of Change (CGI-C) and The Patient Global Impression of Change (PGI-C).

    Time frame: 6 months and 12 months

    Global Impression of change measure evaluating overall change in clinical status compared with baseline.

Secondary outcomes

  1. miSS Score change

    Time frame: 6 months and 12 months

    Change in mISS score from baseline.

  2. SEARS change

    Time frame: 6 months, 12 months

    Change in SEARS score from baseline.

  3. CADT change

    Time frame: 6 months and 12 months

    Change in CADT score from baseline.

  4. SARA change

    Time frame: 6 months and 12 months

    Change in SARA score from baseline.

  5. ONLS change

    Time frame: 6 months and 12 months

    Change in ONLS score from baseline.

  6. I-RODS change

    Time frame: 6 months and 12 months

    Change in I-RODS score from baseline.

  7. 9-Hole Peg Test change

    Time frame: 6 months and 12 months

    Change in 9-Hole Peg Test score from baseline.

  8. Timed Up and Go test change

    Time frame: 6 months and 12 months

    Change in Timed Up and Go test from baseline

  9. Modified Rankin Scale change

    Time frame: 6 months and 12 months

    Change in Modified Rankin Scale from baseline

  10. Quantified Rydel tuning fork test change

    Time frame: 6 months and 12 months

    Change in Quantified Rydel tuning fork test from baseline

  11. Visual Analog Scale change

    Time frame: 6 months and 12 months

    Change in Visual Analog scale frome baseline

  12. Electroneuromyography

    Time frame: 6 months and 12 months

    Change in Electroneuromyography from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Clara PFENNINGER

CONTACT

[email protected]

+33 4 77 12 02 87

Jean philippe PHD CAMDESSANCHE

CONTACT

[email protected]

+33 4 77 12 05 59

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: NEURONOSCORE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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