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

NCT04664426 | Completed

• 1 other identifier: SENS study
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Polyneuropathies

Keywords

polyneuropathy; quantitative sensory testing; nerve conduction studies; adapted modified Toronto Clinical Neuropathy Score; renal transplantation; Erasmus Polyneuropathy Symptom Score

Outcome Measures

Primary Outcomes (4)

• adapted modified Toronto Clinical Neuropathy Score (amTCNS)

  The amTCNS examines signs and symptoms of polyneuropathy. It consists of a questionnaire which explores the presence of neuropathic pain, numbness, tingling, weakness, and loss of sensation leading to ataxia. Secondly, sensory tests will be performed including sensation for pinprick, light touch, proprioception, and vibration. The minimum value is 0 meaning the patient does not show any signs or symptoms of polyneuropathy and the maximum value is 30 meaning the patient presents with severe signs and symptoms of polyneuropathy.

  First test of the study visit, will be performed once (each study participant has a single study visit), Day 1

• Quantitative sensory testing (QST)

  Quantitative sensory testing will be performed according to the method of temperature threshold testing. Both the method of limits and the method of levels will be carried out.

  Second test of the study visit, will be performed once (each study participant has a single study visit), Day 1

• Nerve conduction studies (NCS)

  Sensory nerve action potential (SNAP) amplitude of the sural and ulnar nerve will be recorded and compound muscle action potential (CMAP) amplitude of the tibial, peroneal and ulnar nerve. Furthermore, the soleus Hoffman's reflex will be tested. For all measurements the amplitude (mV), conduction velocity (m/s) and distal latency (ms) of the described nerves will be determined.

  Third test of the study visit, will be performed once (each study participant has a single study visit), Day 1

• Erasmus Polyneuropathy Symptom Score (E-PSS)

  The E-PSS consists of a six-item questionnaire taking the presence and frequency of different polyneuropathic symptoms into account.

  Participants will be asked to fill in the six-time questionnaire of the E-PSS prior to their study visit in the home setting via mail.

Secondary Outcomes (2)

• Muscle strength

  Additional testing during the study visit, will be performed once (each study participant has a single study visit), Day 1

• Reflexes

  Additional testing during the study visit, will be performed once (each study participant has a single study visit), Day 1

Study Arms (1)

Kidney transplant recipients

Kidney transplant recipients will undergo examination according to the E-PSS, amTCNS, QST (thermal threshold testing), and 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 will be measured).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of kidney transplant recipients (KTR).

You may qualify if:

• Age ≥ 18 y.o.
• Patient is able to understand the Dutch language and capable to intellectually comprehend questionnaires and physical tests
• Signed and dated informed consent prior to any study-related procedures
• Previous participation in the TransplantLines cohort study and biobank

You may not qualify if:

• Patient refusal
• Amputation of lower or upper limb(s), trauma of limbs
• Patients with a pacemaker or ICD
• Use of mind-altering drugs in previous 24 hours
• Metal osteosynthesis after bone fracture (in arms or legs)
• Patients with mononeuropathies in examined nerves
• Patients on dialysis after transplantation

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (21)

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• Nolte S, van Londen M, Elting JWJ, de Greef BTA, Kuks JBM, Faber CG, Nolte IM, Groen RJM, Bakker SJL, Groothof D, Lesman-Leegte I, Berger SP, Drost G. Vibration threshold in non-diabetic subjects. PLoS One. 2020 Oct 7;15(10):e0237733. doi: 10.1371/journal.pone.0237733. eCollection 2020.

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  PMID: 40915314 DERIVED

MeSH Terms

Conditions

Polyneuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Gea Drost, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 11, 2020
• Study Start: December 20, 2021
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)