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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Botulinum toxin and Repetitive Transcranial Magnetic Stimulation in treating Cervical Dystonia: A Double-blind Placebo Controlled Trial
Scientific title
Among patients with cervical dystonia, does treating with transcranial magnetic stimulation in addition to botulinum toxin treatment compared with botulinum toxin alone, give additional benefit and improve quality of life
Secondary ID [1] 1566 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Dystonia 257049 0
Condition category
Condition code
Neurological 257212 257212 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
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.
Intervention code [1] 256225 0
Treatment: Other
Intervention code [2] 256245 0
Treatment: Drugs
Comparator / control treatment
Sham repetitive Transcranial Magnetic Stimulation (rTMS) given in addition to botulinum toxin treatment. Sham treatment will be using the same equipment and parameters as above (a total of 5 consecutive daily sessions, each lasting about 30 minutes before a break of 4 months and then receiving the intervention treatment) but with a 'spacer device' used so that no actual electrical stimulation of cortex by the TMS will be possible. The patients in both groups will continue to have usual treatment with botulinum toxin in accordance with clinical need.
Control group

Primary outcome [1] 258102 0
Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores.
Timepoint [1] 258102 0
At baseline, immediately after repetitive transcranial magnetic stimulation treatment and at 1 and 4 months after treatment
Primary outcome [2] 258131 0
Quality of life measures as measured by the The Short Form (36) Health Survey (SF-36)
Timepoint [2] 258131 0
At baseline, immediately after repetitive transcranial magnetic stimulation treatment and at 1 and 4 months after treatment
Secondary outcome [1] 263707 0
Timepoint [1] 263707 0

Key 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
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patients interested in taking part in the project will be given written information regarding the project. If they provide informed consent to be included in the trial, they will be randomly assigned to treatment with botulinum toxin plus sham rTMS (treatment A) or treatment with botulinum toxin and rTMS (treatment B) according to a computerised random allocation schedule. The clinicians assessing the primary end points will be blinded to which treatment arm the patient is in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random allocation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256726 0
Name [1] 256726 0
Monash Medical Centre
Address [1] 256726 0
146 Clayton Road
Victoria 3168
Country [1] 256726 0
Primary sponsor type
Monash Medical Centre
146 Clayton Road
Victoria 3168
Secondary sponsor category [1] 256010 0
Name [1] 256010 0
Address [1] 256010 0
Country [1] 256010 0

Ethics approval
Ethics application status
Ethics committee name [1] 258763 0
Southern Health Ethics Committee
Ethics committee address [1] 258763 0
146 Clayton Road
Clayton Vic 3168
Ethics committee country [1] 258763 0
Date submitted for ethics approval [1] 258763 0
Approval date [1] 258763 0
Ethics approval number [1] 258763 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 30992 0
Address 30992 0
Country 30992 0
Phone 30992 0
Fax 30992 0
Email 30992 0
Contact person for public queries
Name 14239 0
Dr Ganga Ganesvaran
Address 14239 0
Department of Neurology
146 Clayton Road
Victoria 3168
Country 14239 0
Phone 14239 0
+61 3 95946666
Fax 14239 0
Email 14239 0
Contact person for scientific queries
Name 5167 0
Dr Ganga Ganesvaran
Address 5167 0
Department of Neurology
146 Clayton Road
Victoria 3168
Country 5167 0
Phone 5167 0
+61 3 95946666
Fax 5167 0
Email 5167 0

No information has been provided regarding IPD availability
Summary results
No Results