Motor and Non-motor Symptoms in Cervical Dystonia (Royal)

September 16, 2020 updated by: Giovanni Fabbrini, University of Roma La Sapienza

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Anticipated)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of Cervical dystonia

Description

Inclusion Criteria:

  • Cervical dystonia patients (primary dystonia).
  • BoNT-A naïve or pre-treated with any BoNT-A product.
  • Signed informed consent prior to participation in the study. If previously treated with any BoNT-A, at least a 3-4 months interval between last injection and inclusion.

Exclusion Criteria:

  • - All secondary causes of dystonia (e.g. parkinsonian syndromes, or exposition of dopamine receptor blocking drugs) will be excluded.
  • Major psychiatric disorders.
  • Sensitivity to BoNT-A or to its excipients
  • Other contraindications as given in the local SmPC for BoNT-A
  • Pregnant & lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in depression scores from baseline to month 1 and 3
Time Frame: From baseline to month 1 and 3 after treatment
Changes in the Hamilton Rating Scale for depression (HAM-D) before and after three months from treatment
From baseline to month 1 and 3 after treatment
Changes in anxiety scores from baseline to month 1 and 3
Time Frame: From baseline to month 1 and 3 after treatment
Changes in the Hamilton Rating Scale for anxiety (HAM-A) before and after three months from treatment
From baseline to month 1 and 3 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

Ipsen

Investigators

  • Principal Investigator: Giovanni Fabbrini, MD, Depatment Human Neurosciences Sapienza University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Single center study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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