Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001182886
Ethics application status
Not yet submitted
Date submitted
6/11/2012
Date registered
7/11/2012
Date last updated
7/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial of non-invasive stimulation to the cerebellum for cervical dystonia
Scientific title
A clinical trial of non-invasive stimulation to the cerebellum for cervical dystonia to assess symptoms and the impact on a person's life
Secondary ID [1] 281505 0
Nil
Universal Trial Number (UTN)
U1111-1136-7564
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Dystonia 287775 0
Condition category
Condition code
Neurological 288123 288123 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is theta-burst stimulation. This is a form of repetitive transcranial magnetic stimulation (TMS) delivered in a patterned style that can increase or decrease excitability of brain tissue. Theta-burst stimulation will be delivered at a low intensity (80% of active motor threshold of target muscles). 600 pulses are delivered in an intermittent pattern, taking about 3 minutes. The stimulation will be delivered to each cerebellar hemisphere, with a 2 minute break between sides. The intervention will take place every working day for 10 days.
Intervention code [1] 286020 0
Treatment: Devices
Comparator / control treatment
Sham theta burst stimulation will be used as a control intervention, using a sham coil that emits the same noise as the real coil, but does not emit a magnetic pulse. Otherwise the sham intervention will be delivered exactly as for theta-burst stimulation
Control group
Placebo

Outcomes
Primary outcome [1] 288327 0
Toronto Western Spasmodic Tortocollis Scale. This is a validated scale to assess symptoms of cervical dystonia and the impact on a persons life
Timepoint [1] 288327 0
End of intervention period
4 weeks after end of intervention period
12 weeks after end of intervention period
Secondary outcome [1] 299863 0
Cervical Dystonia Quality of Life Questionaire (CDQ-24). This is a qualtify of life questioniare validated for use in people with cervical dystonia, to assess the impact of the disorder on a persons life.
Timepoint [1] 299863 0
End of intervention period
4 weeks after end of intervention period
12 weeks after end of intervention period
Secondary outcome [2] 299864 0
TMS measurements.
TMS will be used to assess excitability of corticomotor neurons and output pathways to the cervical muscles. The measures will be motor-evoked potentials (MEPS), cerebellar brain inhibition (CBI) and short afferent inhibition (SAI).
Timepoint [2] 299864 0
Mid intervention
End of intervention period
4 weeks after end of intervention period
Secondary outcome [3] 299865 0
Grooved pegboard task.
This task will assess manual dexterity. It involves placing pegs into holes that have grooves in different directions meaning pegs must be manipulated into the correct position.
Timepoint [3] 299865 0
Mid intervention
End of intervention period
4 weeks after end of intervention period
Secondary outcome [4] 299866 0
Cervical Range of Motion.
This will be assessed using a goniometric device placed on the head (CROM3).
Timepoint [4] 299866 0
Mid intervention
End of intervention period
4 weeks after end of intervention period

Eligibility
Key inclusion criteria
Diagnosis of cervical dystonia by a neurologist
No botulinum toxin injections in last 10 weeks
Over 18 years of age
No contraindiations to Transcranial Magnetic Stimulation (TMS) or theta-burst stimulation (TBS)
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to TMS
Epilepsy
Neurological or musculoskeletal conditions affecting the neck

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be allocated to a group by an independent investigator using a minimisation process to ensure comparable groups. Allocation will be concealed from investigators performing outcome measurements as interventions are delivered separately to outcome measures. Allocation will be concealed from subjects by use of a sham TMS coil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer randomisation program will be used for sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5964 0
5041
Recruitment postcode(s) [2] 5965 0
5001
Recruitment postcode(s) [3] 5966 0
5042

Funding & Sponsors
Funding source category [1] 286286 0
Charities/Societies/Foundations
Name [1] 286286 0
Brain Foundation
Country [1] 286286 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 285081 0
Hospital
Name [1] 285081 0
Repatriation General Hospital
Address [1] 285081 0
Daws Road,
Daw Park,
Adelaide
SA 5041
Country [1] 285081 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288362 0
Southern Adelaide Clinical Research Ethics committee
Ethics committee address [1] 288362 0
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 288362 0
Australia
Date submitted for ethics approval [1] 288362 0
08/11/2012
Approval date [1] 288362 0
Ethics approval number [1] 288362 0

Summary
Brief summary
The trial is a randomised controlled study into the effect of applying non-invasive brain stimulation to the cerebellum on the symptoms of cervical dystonia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34926 0
Address 34926 0
Country 34926 0
Phone 34926 0
Fax 34926 0
Email 34926 0
Contact person for public queries
Name 18173 0
Lynley Bradnam
Address 18173 0
GPO Box 2100, Adelaide, SA 5001
Country 18173 0
Australia
Phone 18173 0
+61 8 72218291
Fax 18173 0
Email 18173 0
[email protected]
Contact person for scientific queries
Name 9101 0
Lynley Bradnam
Address 9101 0
GPO Box 2100, Adelaide, SA 5001
Country 9101 0
Australia
Phone 9101 0
+61 8 72218291
Fax 9101 0
Email 9101 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCerebellar intermittent theta-burst stimulation and motor control training in individuals with cervical dystonia.2016https://dx.doi.org/10.3390/brainsci6040056
N.B. These documents automatically identified may not have been verified by the study sponsor.