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Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04560101
Study type Observational
Source University of Roma La Sapienza
Contact Alfredo Berardelli, MD
Phone +390649914700
Status Recruiting
Start date August 1, 2020
Completion date June 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03428009 - Dystonia Genotype-Phenotype Correlation
Completed NCT05095493 - Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response N/A