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At a glance

ClinicalIndex Comparison Record
N/ACompleted· 196 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT04664426
NCT04664426N/ACompleted

Adapted Modified Toronto Clinical Neuropathy Score and Erasmus Polyneuropathy Symptom Score Validated by Quantitative Sensory Testing and Nerve Conduction Studies for Kidney Transplant Recipients

University Medical Center Groningen·observational·Posted Dec 11, 2020·Updated Jun 29, 2023

In Brief

An observational study for Polyneuropathies. Completed, enrolled 196 participants across 1 site.

Detailed Summary

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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 11, 2020
Enrollment StartDec 20, 2021
Primary CompletionMay 22, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.6 years ago