Botox for Cervical Dystonia Following EMG Mapping
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin A
Intervention description: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: dystonia; cervical dystonia; Botox; idiopathic primary cervical dystonia

Summary:

      The purpose of this study is to determine how to improve treatment of patients with cervical
      dystonia who have not been helped with standard Botox injections. This study is for patients
      with cervical dystonia who have not benefited from treatment with Botox using conventional
      "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if
      these patients may have significantly more benefit if their Botox is injected into muscles
      that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox
      injection.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female subjects, 18 to 75 years of age.

          -  Ability to follow study instructions and complete all required visits.

          -  Subject meets diagnostic criteria for idiopathic primary cervical dystonia.

          -  Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at
             least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection.

          -  Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an
             outside facility.

          -  Patients will not have received Botulinum toxin within 16 weeks of the start of the
             study.

          -  In order to not confound the clinical response to BTX-A injections, all patients
             enrolled must have been on a stable medication regimen for 30 days. If they are not on
             medication at the initiation of the study, they will not be started on medication.
             Patients must be on the same medication regimen through the entire study including
             assessment of both single lead EMG based injections and "mapping" based injections.
             Medications cannot be stopped during the study to avoid confounding the clinical
             response to BTX-A.

        Exclusion Criteria:

          -  Known allergy or sensitivity to any of the components in BTX-A.

          -  Uncontrolled clinically significant medical condition other than the condition under
             evaluation

          -  Females with a positive pregnancy test, or who are breast-feeding, planning a
             pregnancy during the study, who think that they may be pregnant at the start of the
             study or females of childbearing potential who are unable or unwilling to use a
             reliable form of contraception during the study.

          -  Participation in another medication or device study or within 3 months of enrollment
             in this study.

          -  Patients know to have a positive frontalis test or have previously tested positive for
             the presence of BTX-A antibodies will be excluded.

          -  Any known evidence of cervical contractures or significant spinal deformity.