Last reviewed · How we verify

NCT04664426: SENS

Sensory Neuropathy Scores Validated by Quantitative Sensory Testing and Nerve Conduction Studies for Kidney Transplant Recipients

Completed Last updated 29 June 2023
What this trial tests

trial in Polyneuropathies in 196 participants. Completed in 22 May 2023.

Timeline
20 December 2021
Primary endpoint
22 May 2023
22 May 2023

Quick facts

Lead sponsorUniversity Medical Center Groningen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment196
Start date20 December 2021
Primary completion22 May 2023
Estimated completion22 May 2023
Sites1 location across Netherlands

Conditions studied

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Polyneuropathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sensory polyneuropathy is one of the most prevalent neurological disorders and a common finding in kidney transplant recipients (KTR). However, prevalence, course and underlying aetiology in this specific patient group remain unexplored. To diagnose sensory polyneuropathy in KTR in clinical practice, a relatively easy and inexpensive method is needed. The Erasmus Polyneuropathy Symptom Score (E-PSS) and the adapted modified Toronto Clinical Neuropathy Score (amTCNS) are such scores. These scores would enable internal medicine physicians to diagnose polyneuropathy in a reliable way without the need of additional examinations. However, a validation of the E-PSS and amTCNS with the golden standard of diagnosing sensory polyneuropathy, which are quantitative sensory testing (QST) and nerve conduction studies (NCS), is needed. The objective of this observational cross-sectional study is to validate the E-PSS and amTCNS with QST and NCS and to determine reference values of the amTCNS. 200 KTR will be included to take part in one study visit which encompasses neurological examination according to the protocol of the amTCNS, QST and NCS. Prior to the study visit, participants will be asked to answer the E-PSS questionnaire in the home setting. The main study endpoint is to validate the E-PSS and the amTCNS result with QST and NCS. To reach this endpoint different study parameters will be included which are the result of the E-PSS and amTCNS, results of the QST (thermal threshold testing), and results of the NCS (amplitude, velocity and distal latency of measurements at the sural sensory nerve, ulnar sensory nerve, peroneal motor nerve, tibial motor nerve and ulnar motor nerve, soleus H reflex).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. TransplantLines, a biobank and cohort study of solid organ transplant recipients and donors.
    Posthumus AM, Knobbe TJ, Kremer D, Gomes-Neto AW, et al · · 2025 · cited 3× · PMID 40601244 · DOI 10.1007/s10654-025-01258-1
  2. Polyneuropathy in Kidney Transplant Recipients: Accuracy of a New Clinical Diagnostic Scoring System.
    Nolte S, Shehab NBN, Berger SP, Oldag C, et al · · 2025 · cited 1× · PMID 40915314 · DOI 10.1111/jns.70058
  3. Polyneuropathy in kidney transplant recipients: a cross-sectional study in Groningen, the Netherlands.
    Nolte S, Moes HR, Bakker SJL, Oldag C, et al · · 2026 · PMID 42242744 · DOI 10.1136/bmjopen-2025-100862

Verify or expand the search:

Other recruiting trials for Polyneuropathies

Currently open trials in the same condition.

Other University Medical Center Groningen trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04664426.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing