Dystonia Treatment With Injections Supplemented By Transcranial Magnetic Stimulation
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      We will apply 16 sessions of rTMS over 4 consecutive days for adult patients suffering from
      cervical dystonia who receive botox on a regular basis. The TMS protocol will take place 9
      weeks following their last botox injection. The primary outcome measure will be improvement
      in cervical dystonia as measured by the TWSTRS scale. The secondary outcome measures include
      mood, cognition, gait, TMS measures, and high-density EEG measures.
    

Detailed description: 
      This is a crossover study design in which patients will be randomized to active or sham
      stimulation during session 1 (S1) and then crossover to the condition they were not
      randomized to at first during session 2 (S1). Patients who are receiving botox for cervical
      dystonia on a regular basis but having benefit from botox for 9 weeks or less will be
      eligible to participate. The total study protocol will take place over 24 weeks. During week
      1, patients will have their regularly scheduled botox injections. During week 9, patients
      will undergo either active or sham rTMS, as detailed below. They will have outcome measures
      obtained at week 9 (S1:T0; baseline/pre-TMS), week 10 (S1:T1; post-TMS), and week 12 (S1:T2;
      2 weeks post-TMS). At week 12, they will undergo their regularly scheduled botox injections.
      During week 21, patients will undergo either active or sham rTMS, whichever condition they
      were not randomized into during the first session. They will have outcome measures obtained
      at week 21 (S2:T0; baseline/pre-TMS), week 22 (S2:T1; post-TMS), and week 24 (S2:T2; 2 weeks
      post-TMS).

      The neurostimulation protocol will be as follows: The dPMC target will be defined as 1 cm
      medial and 2 cm anterior to the site of RMT acquisition. The rTMS protocol will be as
      follows: each session will consist of 1-Hz rTMS over the dPMC for 30 minutes (1800 pulses) at
      90% of the RMT. Patients will receive 4 sessions per day for 4 consecutive days with a
      10-minute break between each session. Daily duration of the rTMS protocol, including breaks,
      will last approximately 160 minutes
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): repetitive transcranial magnetic stimulation is a painless, noninvasive form of neurostimulation. This study uses an accelerated protocol in which the neurostimulation pulses are delivered in 4 sessions per day over 4 consecutive days (16 total sessions). Active or sham rTMS will be provided at 9 weeks following botox injections.
Other intervention name(s): Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will be randomized to one of two conditions during session 1: active or sham rTMS. During session 2, patients will undergo whichever condition they did not undergo in session 1.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; cervical dystonia; botulinum toxin