-To confirm the potential of a diagnostic tool to discriminate dystonic from non-dystonic muscles in CD patients-To explore the potential to discriminate CD patients from Functional Torticollis (FT) patients
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of the new method in muscle selection. The accuracy will be
calculated using the diagnostic odds ratio, sensitivity and specificity.
Secondary outcome
The differences in characteristics and distribution of abnormal activation
patterns between CD patients and FT patients .
Additional outcome in CD patients that are currently receiving BTX treatment:
The differences in characteristics and prevalence of abnormal activation
patterns before and after botulinum toxin treatment.
Background summary
Cervical dystonia (CD), also called spasmodic torticollis, is characterized by
sustained involuntary muscle contractions of the neck leading to debilitating
abnormal postures, pain and twisting movements. The first line of treatment in
CD are intramuscular botulinum toxin (BTX) injections in the dystonic muscles.
The diagnosis CD is a based on clinical examination and observation and no
definite additional diagnostic tools are available. Accurate diagnostic tools
are required for proper selection of dystonic muscles for BTX treatment and for
confirmation of the clinical diagnosis.
Study objective
-To confirm the potential of a diagnostic tool to discriminate dystonic from
non-dystonic muscles in CD patients
-To explore the potential to discriminate CD patients from Functional
Torticollis (FT) patients
Study design
Case-control pilot study.
Methods: A new developed isometric contraction device (see 8.3) will be used to
identify dystonic muscles. The identification is based on specific abnormal
muscle activation patterns during isometric force tasks in different
directions. To confirm the discriminative value for muscle selection in CD
patients we will compare the muscles selected by the new method to the
clinically identified muscles (*gold standard*) in CD patients. In addition, to
explore the potential to discriminate CD patients from FT patients, we will
compare (abnormal) activation patterns across these groups.
Study burden and risks
Patients and controls will have to come to the AMC for 2-3 hours. They will
undergo a neurological examination, fill out a questionnaire and participate in
the experiment. This experiments might lead to minor discomfort but the risks
associated with the experiment are minimal.
To investigate/rule out any effects of botulinum toxin treatment on the
results, the CD patients that are currently treated with botulinum toxin will
be measured twice: once before the botulinum toxin treatment and once 4 weeks
after the treatment.
meibergdreef 9
Amsterdam 1105 AZ
NL
meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients with idiopatic cervical dystonia
Age of onset *26
botulinum toxin treatment naive or last treatment more then 3 months ago
Informed consent
Exclusion criteria
Fixed dystonia (often considered a sign of psychogenic torticollis)
Secondary dystonia
Use of neuropharmaceuticals
Pregnancy
Design
Recruitment
Medical products/devices used
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 | NL44382.018.13 |