Clinical Evaluation of Sensory Neuronopathies: the Neuronoscore Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient unable to understand or read French

Patient refusal to participate

Diabetes mellitus

Significant alcohol consumption

Trial design

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Group experimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
6 months and 12 months

Secondary outcomes

1

miSS Score change

Change in mISS score from baseline.

Time frame
6 months and 12 months
2

SEARS change

Change in SEARS score from baseline.

Time frame
6 months, 12 months
3

CADT change

Change in CADT score from baseline.

Time frame
6 months and 12 months
4

SARA change

Change in SARA score from baseline.

Time frame
6 months and 12 months

Other outcomes

Sponsors and contacts

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