Primary Objective: Collection of CMAP scan normal valuesSecondary Objectives: Assessment of the influence of gender, age, and side on the CMAP scan and its variables
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will collect normal values for the CMAP scan variables threshold
intensity S0, maximum intensity S100, maximum CMAP, asymmetry, number of steps,
step size, and summed step size as percentage of the maximum CMAP.
Secondary outcome
-
Background summary
The CMAP scan is a noninvasive neurophysiological tool that records the
electrical activity of a muscle in response to repetitive transcutaneous
stimulation of the motor nerve. Patterns in or properties of this CMAP scan
provide clinically relevant information and the method is easy to apply and
interpret. For these reasons, the scan is a promising new diagnostic
instrument. A further description of the method can be found in the protocols
of previously approved studies MEC-2005-277 and MEC-2007-205. The former study
concerned the initial exploration of the approach and has led to a
peer-reviewed publication in 2007.1 The second study addressed the optimal
settings for performing a CMAP scan. A publication of this study is in
preparation, and its results will be applied in the present study.
The next step toward establishing the CMAP scan as a novel electrodiagnostic
instrument is the determination of the distribution of CMAP scan variables that
is present in a healthy population. This is an essential step in the validation
of the method, because to be able to qualify a scan as abnormal, limits to what
is normal need be known. Since normal values may be age-, gender-, side- and
muscle-dependent, normal values will be collected for each of these
subcategories.
Study objective
Primary Objective:
Collection of CMAP scan normal values
Secondary Objectives:
Assessment of the influence of gender, age, and side on the CMAP scan and its
variables
Study design
In this cross-sectional observational multicenter study, we will record CMAP
scans bilaterally in 6 different muscles of 140 healthy subjects: 10 male and
10 female, in each of the categories 18-29, 30-49, 40-49, 50-59, 60-69, 70-79,
and >= 80 years of age.
The CMAP scan was initially designed in the Erasmus MC and continues to be
developed with three international centers: Mayo Clinics, Rochester, USA;
University of Utah, Salt Lake City, USA; and Royal Women*s and Children*s
Hospital, Brisbane, Australia. Each of these centers has agreed to study at
least 20 healthy subjects.
Study burden and risks
The investigations are noninvasive. There are no risks, nor are there immediate
benefits for individual subjects.
Postbus 2040
3000 CA Rotterdam
Nederland
Postbus 2040
3000 CA Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
age >18
normal nerve conduction study of the median nerve
written informed consent
Exclusion criteria
neurological disease
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol. Judgment is up to the investigator.
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 |
---|---|
CCMO | NL22976.078.08 |