The main study objective is to determine the prevalence of tremor in patients with neuropathy and describe the tremor characteristics.Secondary study objectives are: - To evaluate the functional disability and quality of life in patients with…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the prevalence of tremor in demyelinating
neuropathy and the tremor characteristics.
Secondary outcome
- Association between presence of tremor and tremor severity with increase in
functional disability and decrease in quality of life in patients with
neuropathy, after correction for other impairment modalities such as sensory
impairment and muscle weakness.
- Changes in tremor severity, impairment and functioning during follow-up.
- Explorative anaylsis of clinical, laboratory, fMRI and neurophysiological and
fMRI characteristics of patients with tremor and patients without tremor to
further elucidate the pathophysiology of tremor in demyelinating
polyneuropathie.
- The difference in prevalence between patients with demyelinating
polyneuropathy and axonal polyneuropathy.
Background summary
Disabling tremor is an underrecognised symptom of demyelinating and perhaps
axonal neuropathy with a yet unknown aetiology. The prevalence of tremor in
different types of neuropathy is unclear, as well as tremor characteristics and
burden due to tremor in these patients. In addition, there is limited and
variable data concerning the effect of treatment of the underlying neuropathy
on tremor and of treatment specifically aimed at neuropathic tremor.
Study objective
The main study objective is to determine the prevalence of tremor in patients
with neuropathy and describe the tremor characteristics.
Secondary study objectives are:
- To evaluate the functional disability and quality of life in patients with
neuropathy with and without tremor.
- To evaluate whether tremor severity correlates with changes in disease
activity of underlying neuropathy
- To compare clinical, laboratory, and neurophysiological and fMRI
characteristics of patients with neuropathy with tremor with patients without
tremor to gain insight in pathophysiology and potential therapies.
- To compare the prevalence of tremor and tremor characteristics in
demyelinating polyneuropathy with chronic axonal polyneuropathy.
Study design
Observational cross sectional study additionaly using prospective and
retrospective data analysis of patients with polyneuropathy. Presence and
characteristics of tremor will be evaluated by means of questionnaires and
video assessment, as well as tremor registration, and, in selected patients,
reflex loop studies and/or functional MRI in selected patients.
Study burden and risks
There are no risks associated with participation in the study. The major burden
is the time associated with the study visits: three visits of 60-90 minutes
will take place over a timeperiod of 12-24 months.
A selection of patients (up to twenty patients with and twenty patients without
tremor) will be included in an additional part of the study using
wristperturbation and functional magnetic resonance imaging (fMRI). In total
the additional asessments will maximally cost patients 4 1/4 hours. There will
be no hazards for patients participating in these additional assessments if the
contra-indications for MRI are applied correctly.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with demyelinating neuropathy with and without tremor
1) CIDP
For the diagnosis CIDP we will use the EFNS/PNS criteria for the diagnosis of
CIDP. In addition we will include patients fulfilling the clinical criteria and
at least two supportive criteria (24).
2) IgM paraproteinemic neuropathy
Patients with chronic distal polyneuropathy with either axonal or demyelinating
characteristics and presence of monoclonal IgM antibodies (24).
3) CMT-1A and CMT-1B
Patients with uniform demyelinating polyneuropathy, genetically confirmed in
patient or in a first degree relative.
Patients with axonal neuropathy with and without tremor
- EMG confirmed axonal polyneuropathy according to EMG examination in Amsterdam
UMC or patients clinically diagnosed with a chronic axonal polyneuropathy
during an outpatient clinic visit at the AMC, without an EMG examination. These
patients will be included by searching electronic health records in the time
frame of January 1st until December 31st 2017;
- the etiology of the neuropathy is either diabetes mellitus, chronic
idiopathic axonal polyneuropathy (CIAP) or medication induced (provided the
causative drug cannot induce tremor) according to the last diagnosis registered
and is not associated with demyelinating disorders;
- neuropathy with a chronic course (symptoms for over 3 months).
Additional inclusion criteria that apply to all groups above:
- age >=18 years
- informed consent
Exclusion criteria
- insufficient knowledge of the Dutch language
- inability to visit the hospital
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL66092.018.18 |