Motor and Non-motor Symptoms in Cervical Dystonia

NCT04560101 | Unknown DMC FDA Drug

• 1 other identifier: 5491
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dystonia, Focal

Keywords

depression; anxiety; sleep; cognitive

Outcome Measures

Primary Outcomes (2)

• Changes in depression scores from baseline to month 1 and 3

  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

  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

Interventions

botulinum toxin A DRUG

Intramuscolar injection of botulinum toxin in affected muscles

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of Cervical dystonia

You may qualify if:

• Cervical dystonia patients (primary dystonia).
• BoNT-A naïve or pre-treated with any BoNT-A product.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Ipsen: collaborator

Study Sites (1)

Department of Human Neurosciences

Rome, 00185, Italy

RECRUITING

Related Publications (8)

• Fabbrini G, Berardelli I, Moretti G, Pasquini M, Colosimo C, Berardelli A. Nonmotor symptoms in adult-onset focal dystonia: psychiatric abnormalities. Mov Disord. 2011 Aug 1;26(9):1765-6. doi: 10.1002/mds.23668. Epub 2011 Mar 25. No abstract available.

  PMID: 21442656 RESULT

• Berardelli I, Ferrazzano G, Pasquini M, Biondi M, Berardelli A, Fabbrini G. Clinical course of psychiatric disorders in patients with cervical dystonia. Psychiatry Res. 2015 Sep 30;229(1-2):583-5. doi: 10.1016/j.psychres.2015.07.076. Epub 2015 Jul 29.

  PMID: 26239770 RESULT

• Conte A, Berardelli I, Ferrazzano G, Pasquini M, Berardelli A, Fabbrini G. Non-motor symptoms in patients with adult-onset focal dystonia: Sensory and psychiatric disturbances. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S111-4. doi: 10.1016/j.parkreldis.2015.09.001. Epub 2015 Sep 3.

  PMID: 26360238 RESULT

• Ferrazzano G, Berardelli I, Conte A, Suppa A, Fabbrini G, Berardelli A. Interoceptive sensitivity in patients with cervical dystonia. Parkinsonism Relat Disord. 2017 Nov;44:129-132. doi: 10.1016/j.parkreldis.2017.08.019. Epub 2017 Aug 16.

  PMID: 28827008 RESULT

• Ferrazzano G, Berardelli I, Conte A, Baione V, Concolato C, Belvisi D, Fabbrini G, Defazio G, Berardelli A. Motor and non-motor symptoms in blepharospasm: clinical and pathophysiological implications. J Neurol. 2019 Nov;266(11):2780-2785. doi: 10.1007/s00415-019-09484-w. Epub 2019 Jul 29.

  PMID: 31359200 RESULT

• Berardelli I, Ferrazzano G, Belvisi D, Pompili M, Fabbrini G. Psychiatric disorders in blepharospasm: A 10-year follow-up study. Psychiatry Res. 2020 Aug;290:113092. doi: 10.1016/j.psychres.2020.113092. Epub 2020 May 26. No abstract available.

  PMID: 32505028 RESULT

• Ferrazzano G, Berardelli I, Belvisi D, De Bartolo MI, Di Vita A, Conte A, Fabbrini G. Awareness of Dystonic Posture in Patients With Cervical Dystonia. Front Psychol. 2020 Jun 23;11:1434. doi: 10.3389/fpsyg.2020.01434. eCollection 2020.

  PMID: 32655462 RESULT

• Berardelli I, Ferrazzano G, Belvisi D, Baione V, Fabbrini G, Innamorati M, Berardelli A, Pompili M. Suicidal ideation, hopelessness, and affective temperament in patients with blepharospasm. Int J Psychiatry Clin Pract. 2021 Nov;25(4):344-349. doi: 10.1080/13651501.2020.1790613. Epub 2020 Jul 15.

  PMID: 32669012 RESULT

MeSH Terms

Conditions

Dystonic Disorders; Depression; Anxiety Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Giovanni Fabbrini, MD

  Depatment Human Neurosciences Sapienza University of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfredo Berardelli, MD

CONTACT

+390649914700; alfredo.berardelli@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 23, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)