None listed
Conditions
Brief summary
Cervical dystonia is the term used to describe a certain pattern of involuntary neck muscle movements. The most effective current treatment for cervical dystonia is injecting overactive muscles with botulinum toxin type A, inducing paralysis of the overactive muscles. Botulinum toxin type A is approved in Australia to treat cervical dystonia. Disadvantages of this therapy are the discomfort associated with the treatment, its temporary effect and lack of response in some cases. There is emerging evidence for efficacy of low frequency repetitive transcranial magnetic stimulation (rTMS), for relief of symptoms in focal forms of dystonia, including cervical dystonia. rTMS is a technique for stimulating a part of the brain in a non-invasive way. In this case, magnetic pulses are delivered through the scalp and stimulate the brain cells. The procedure is largely pain free and has no significant adverse effects. This technique has been used for research as well as treatment of several neurological disorders. rTMS can lead to changes in the brain area stimulated, that persist after the stimulus. There is some evidence that these changes can be used in the treatment of cervical dystonia. However, it is still an experimental treatment. This means that it is not an approved treatment for treatment of dystonia in Australia or other parts of the world. This study aims to investigate if treatment of cervical dystonia with Botulinum toxin injection, when combined with rTMS, produces an additive effect. If the latter treatment is found to have a significant additive effect, it may offer a rationale to directly compare rTMS with botulinum toxin. If rTMS is effective as a treatment on its own, it may offer a less painful and perhaps longer lasting alternative to botulinum toxin injections.
Interventions
repetitive Transcranial Magnetic Stimulation (rTMS) given in addition to botulinum toxin treatment given in accordance with clinical need. We will use repetitive Transcranial Magnetic Stimulation (rTMS) parameters demonstrated to have a clinical benefit in a previous case study in cervical dystonia. This will consist of stimulation over the premotor cortex contra lateral to the overactive sternoceidomastoid muscle, 2.5cm anterior to the optimal scalp position for activation of 1st dorsal interos
repetitive Transcranial Magnetic Stimulation (rTMS) given in addition to botulinum toxin treatment given in accordance with clinical need. We will use repetitive Transcranial Magnetic Stimulation (rTMS) parameters demonstrated to have a clinical benefit in a previous case study in cervical dystonia. This will consist of stimulation over the premotor cortex contra lateral to the overactive sternoceidomastoid muscle, 2.5cm anterior to the optimal scalp position for activation of 1st dorsal interosseous muscle. 1200 pulses will be given at a frequency of 1 Hz with an intensity of 90% of motor threshold in a total of 5 consecutive daily sessions, each lasting about 30 minutes. The washout period between the two treatments of the study will be 4 months, after which the participants will receive the alternate treatment.
Sponsors
Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients are to be recruited from the Botulinum Toxin Outpatient Clinics at the Monash Medical Centre. All consenting patients with clinical diagnosis of rotational cervical dystonia and stable requirements of Botulinum toxin in the previous 6 months will be included
Exclusion criteria
Exclusion criteria will include those patients with intracranial metal objects or pacemakers, seizures or family history of seizures, pregnant women, those with known excessive alcohol use or serious medical conditions
Outcome results
None listed