rTMS and Botulinum Toxin in Primary Cervical Dystonia
Primary Cervical Dystonia, Dystonia
About this trial
This is an interventional treatment trial for Primary Cervical Dystonia focused on measuring Botulinum Toxin, Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of PCD in accordance with the Consensus Statement of the Movement Disorder Society
- Subjects who report Botulinum Toxin benefits lasting 10 weeks or less only (suboptimal benefits with standard care)
Exclusion Criteria:
- Pregnancy
- Active seizure disorder
- Presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.
Sites / Locations
- UF Center for Movement Disorders & Neurorestoration
- UF Brain Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Real rTMS Stimulation
Sham rTMS Stimulation
Repetitive TMS will be delivered over each cerebellar hemisphere, using a NeuroStar TMS therapy system. The coil will be positioned 3 cm lateral to the inion on the line joining the inion and the external auditory meatus. The coil position will be marked on the skin. 900 pulses will be delivered consecutively to each side with a frequency of 1 Hz and at an intensity of 90% of the resting motor threshold (RMT) for a total duration of 15 min for each cerebellar hemisphere. The RMT will be defined as the lowest stimulation intensity required to evoke a 50 μV potential in a target muscle. Constant coil position will be continuously monitored during the experiment. A similar protocol will be observed for the contralateral cerebellum. In addition, this group will have the following performed: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) test, Cerebellar-brain Inhibition (CBI) measurement, and Craniocervical Dystonia Questionnaire (CDQ-24) questionnaire to fill out.
Patients will undergo the same procedure for identifying stimulus location used in patients receiving real rTMS. Simulated rTMS will be administered using sham NeuroStar TMS therapy system coil which produces discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide more effective blinding compared to other methods use in previous controlled studies. In addition, this group will have the following performed: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) test, Cerebellar-brain Inhibition (CBI) measurement, and Craniocervical Dystonia Questionnaire (CDQ-24) questionnaire to fill out.