Primary objective:To validate the adapted modified Toronto Clinical Neuropathy Score (amTCNS) with quantitative sensory testing and nerve conduction studies. Hypothesis: a. Quantitative sensory testing is correlated to the amTCNS indicating that…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is to validate the amTCNS result with quantitative
sensory testing and nerve conduction studies.
The following endpoints will be included:
1. amTCNS result (score between 0 and 30)
2. Quantitative sensory testing: thermal threshold testing
3. Nerve conduction studies: SNAP amplitude, CMAP amplitude and distal motor
latency, nerve conduction velocity, H-reflex
Secondary outcome
In addition to the amTCNS, temperature sense, muscle strength and reflexes will
be examined to assess whether they should be included in the amTCNS for a
better specificity and sensitivity of the score for quantifying the severity of
polyneuropathy.
Background summary
Sensory polyneuropathy (PNP) is one of the most prevalent neurological
disorders and a common finding in renal transplant recipients (RTR). The aim is
to diagnose PNP with a questionnaire and simple physical exam. The adapted
modified Toronto Clinical Neuropathy Score (amTCNS) is such a score method.
However, the amTCNS first needs to be validated with the golden standard for
diagnosing PNP (Quantitative Sensory Testing (QST) and Nerve Conduction Testing
(NCS)). In addition to the benefit of better mapping the incidence of PNP,
early diagnosis and treatment of certain PNP may prevent further worsening of
symptoms. The medication in question can also be adjusted.
Study objective
Primary objective:
To validate the adapted modified Toronto Clinical Neuropathy Score (amTCNS)
with quantitative sensory testing and nerve conduction studies.
Hypothesis:
a. Quantitative sensory testing is correlated to the amTCNS indicating that
small nerve fibre deficits can be detected.
b. Nerve conduction studies are correlated to the amTCNS indicating that large
nerve fibre deficits can be detected.
Secondary objective:
To define reference values of the amTCNS dependent on predictors in a healthy
subject population.
Study design
This research protocol contains a cross-sectional study or can alternatively be
described as a validation study. The aim is to investigate the reliability of
the amTCNS. This is a clinical score designed to capture symptoms and signs of
sensory PNP. The amTCNS will be validated with quantitative sensory testing and
nerve conduction studies which are considered as golden standard for diagnosing
small fibre neuropathies and large fibre neuropathies, respectively.
The aim is to validate the amTCNS for a population of RTR in order to reliably
diagnose PNP.
Study burden and risks
Participants of this study will attend the research facilities for a single
study visit of 150 minutes. During this study quantitative sensory testing and
nerve conduction studies will be performed. These examinations can cause some
discomfort during the test, but side effects very rarely occur. Both are tests
that are performed in daily clinical practice in the regular patient care.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
All >=18 years of age
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
Exclusion criteria
Patient refusal
Amputation of lower or upper limb(s) bilaterally, 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04664426 |
| CCMO | NL74617.042.20 |