Dystonia, Focal Clinical Trial
Official title:
Motor and Non-motor Symptoms in Patients With Cervical Dystonia and the Effect of Treatment With Botulinum Toxin A
In this monocenter, observational, non-interventional, prospective, open label study
investigators will enrol 43 CD patients from the outpatient Movement Disorders Clinic of the
Department of Human Neurosciences, Sapienza University of Rome.
As this is a non-interventional study, no diagnostic, therapeutic or experimental
intervention is involved. Subjects will receive clinical assessments, medications and
treatments solely as determined by their study physician. The BoNT-A injection will be
performed in CD patients at baseline.
As this is an observational, non-interventional study, the injection protocol for BoNT-A
treatment is upon physicians' decision. All CD patients will undergo up to three evaluations
of motor and non-motor symptoms: before (baseline) and 1 month and 3 months after botulinum
toxin treatment. Both evaluations will be carried out under the same conditions. Motor
symptoms will be assessed in all CD using the Comprehensive Cervical Dystonia Rating scale
(CCDRS) (Comella et al, 2015). Non-motor symptoms including psychiatric, psychological and
sleep disorders will be investigated. Psychiatric symptoms will be assessed with CCDS,
Hamilton Rating Scale for Anxiety (HAM-A) and the Hamilton Rating Scale for Depression
(HAM-D); the psychological symptoms will be assessed with the demoralization scale (Kissane
et al, 2004) and the Italian Perceived Disability Scale (Innamorati et al,2009). Sleep
disorders will be investigated with the Pittisburg Sleep Quality Index (PSQI) (Buysse et al,
1989).
Cervical dystonia (CD) is a focal dystonia, characterized by sustained muscle contractions of
the neck causing repetitive movements, or abnormal postures. The muscles' activation pattern
may lead to neck rotation (torticollis), flexion (anterocollis), extension (retrocollis), or
head tilt (laterocollis) or a combination of these. Patients with CD may also have head
tremor.
In addition to motor symptoms, CD patients may have non-motor features including psychiatric
disturbances, sleep difficulties, cognitive impairment and neck pain.
The first line of treatment for CD is botulinum toxin-A (BoNT-A) injection therapy
administered approximately at every 12 weeks. Several studies showed that one month after
BoNT-A treatment there is an improvement of motor symptoms in the majority of CD patients.
Conversely, regarding the effect of BoNT-A on non-motor symptoms previous studies in CD
focused only on the possible effect on depressive symptoms and on neck pain.
No study has so far investigated whether the treatment with BoNT-A may improve non-motor
symptoms in CD, including psychological aspects, such as demoralization and perceived
disability.
Main aim of this study is therefore to assess the effect of botulinum neurotoxin type A
(BoNT-A) treatment on motor and non-motor symptoms, including psychiatric and psychological
symptoms (anxiety, depression, demoralization, perceived disability) and sleep. To this aim
CD patients will be re-tested at 1 month and at 3 months after the treatment with BoNT-A.
Investigators will also assess a possible relationship between the improvements of motor
symptoms with that of non-motor symptoms at 1 month and at 3 months after BoNT-A treatment
and the frequency and severity of non-motor symptoms in a large population of CD patients.
To see whether non-motor symptoms in CD are the consequence of motor symptoms, investigators
will compare the severity of non-motor symptoms with the severity of motor symptoms, as well
as with the different clinical patterns of CD and with the presence or absence of head
tremor.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03428009 -
Dystonia Genotype-Phenotype Correlation
|
||
| Completed |
NCT05095493 -
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
|
N/A |