Probing the role of sodium channels in painful neuropathies (PROPANE Study)

Recruiting

• Conditions: painful neuropathy; Peripheral neuropathy; 10034606

• Registration Number: NL-OMON43862
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

Subjects with Painful PN must meet all of the following inclusion criteria to be eligible for participation:
a. Fulfillment of the international diagnostic criteria for snall fiber neuropathy, for painful diabetic neuropathy or for chemotherapy induced PN by taxane in breast, ovarian or prostate cancer and oxaliplatin in colon cancer. Patients with CIPN have completed their chemotherapy treatment.
b. Maximal pain VAS scores must be at least 40 (range: 0 - 100) (without neuropathic pain medication; in case of use of neuropathic pain medication, the VAS-score in the past without medication to the best of patients knowledge will be used)
c. Age 18 years or older.
d. Each subject will receive an information leaflet and an informed consent form. Subjects must give informed consent by signing and dating an informed consent form prior to study entry. Subjects must be willing to complete all study-related activities and examination required by the protocol.
e. For the control groups, maximal pain VAS scores must be less than 40, preferably < 25 (range: 0 - 100).;Healthy controls (n = 20) must meet the following inclusion criteria to be eligible for participation:
a. Age of 30 - 80 years
b. Absence of the diagnosis of neuropathy or chronic pain disorders

Exclusion Criteria

Concomitant diseases that might interfere with the interpretations of the results.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The presence of mutations in SCN3A, SCN6A, SCN9a, SCN10a, SCN11a genes, in<br /><br>addition, in those patients with small fiber neuropathy or idiopathic<br /><br>neuropathy without mutations in the sodium channels and high chance of a<br /><br>genetic origin (age at onset < 40 years and/or positive family history) whole<br /><br>exome sequencing will be performed.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>na.</p><br>