rTMS and Botulinum Toxin in Primary Cervical Dystonia
Condition: Primary Cervical Dystonia; Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently
      reported as a source of disability, decreased quality of life, and social stigma. Botulinum
      toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from
      BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure
      symptomatic benefits and does not seem to modify the disease pathophysiology.

      The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as
      an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD.
      The primary goal of this study is to compare standard treatment with BoNT versus BoNT
      combined with a two week course of rTMS.
    

Detailed description: 
      rTMS refers to the application of transcranial magnetic stimulation (TMS) pulses to a
      specific target at predefined stimulation parameters. Repeated sessions of rTMS therapy have
      been demonstrated to induce cumulative persistent benefits that can last weeks after the
      conclusion of the rTMS sessions

      The central hypothesis of this study is that rTMS therapy in PCD can potentiate the effects
      of BoNT injections. With the current standard treatment, the peak-dose benefits seen with
      BoNT are seen at about 4-6 weeks after the administration of injections. The investigator
      will introduce a 1 week course of rTMS around 2-8 weeks before or after BoNT or T1). The
      investigator will examine the effects of combined therapy at 10 weeks after BoNT and 12 weeks
      after BoNT injections follow-up.
    

Intervention name(s): NeuroStar TMS therapy; Sham NeuroStar TMS therapy; Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS); Craniocervical Dystonia Questionnaire (CDQ-24); Cerebellar-brain Inhibition (CBI); Botulinum toxin injections
Intervention type(s): Device; Device; Other; Other; Other; Procedure
Intervention description(s): Application of repetitious transcranial magnetic stimulation (TMS) pulses using NeuroStar device to a specific brain target at predefined stimulation parameters.; Same procedure as real rTMS without stimulating the cerebral cortex.; All participants will receive a clinical assessment of dystonia severity by using the TWSTRS test.; All participants will fill out the Craniocervical Dystonia Questionnaire (CDQ-24) quality of life questionnaire.; All participants will have a measure of the cerebellar-brain inhibition(CBI) which will be conducted by using a TMS device determining the ability of the coil to activate the cerebellum.; All participants will receive Botulinum toxin(BoNT) injections as part of their standard of care
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Botulinum Toxin; Transcranial Magnetic Stimulation