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Trial registered on ANZCTR
Registration number
ACTRN12612000339853
Ethics application status
Approved
Date submitted
20/03/2012
Date registered
23/03/2012
Date last updated
23/03/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Non-invasive cerebellar stimulation for focal dystonia
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Scientific title
Focal Dystonia treated using transcranial direct current stimulation compared to sham stimulation on neurophysioloigcal and functional measures
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Secondary ID [1]
280170
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NIL
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Universal Trial Number (UTN)
U1111-1129-1432
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Focal Dystonia
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Condition category
Condition code
Neurological
286295
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Transcranial Direct Current Stimulation (TDCS) is a painless form of non-invasive brain stimulation. It is proposed to work by polarising brain tissue beneath the stimulating electrodes. Usually applied over the motor cortex, TDCS can either increase (anodal) or suppress (cathodal) excitability depending on electrode configuration. In this study, TDCS will be applied over the cerebellum. The current will be applied at 2mA for 20 minutes in three separate sessions, one week apart. The order of the sessions will be randomised. Two sessions will be cathodal, andodal and sham session. The randomisation order and the intervention will be applied by an independent investigator. Investigators who are collecting and analysing data will remaind blinded until the end of the study period.
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Intervention code [1]
284499
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Treatment: Devices
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Comparator / control treatment
Sham stimulation will be applied by turning the machine on for 30 seconds and then switching it off. This allows the participant to experience the sensory stimulation associated with the current ramping up, to maintain blinding as to the condition. No current is used for the remainder of the 20 minute intervention.
In addition to undergoing sham stimulation, each patient will be age and gender matched to a healthy control participant. They will act as controls and will undergo the same procedures as the patients.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Neurophysiological measures using Transcranial Magnetic Stimulation (TMS). TMS is used to test excitability of intracortical brain circuits, that are known to be affected in primary focal dystonia. A change in these measures more toward 'normal' (as measured by comparison to a healthy group) will indicate improvement.
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Assessment method [1]
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Timepoint [1]
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Immediately post treatment
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Secondary outcome [1]
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Handwriting and circle drawing tasks will be used to assess kinematics before and after the intervention. An improvement in these tasks is expected. The measures of interest include stroke frequency, mean pen pressure and the Coefficient of Variation of positive velocity peaks (CV). These are calculated using computer software. The Handwriting task will also be analysed using the Writers Cramp Rating Scale (WCRS) by an independent assesor.
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Assessment method [1]
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Timepoint [1]
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Immediately post treatment
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Eligibility
Key inclusion criteria
Over 18 years of age,
Diagnosis of Primary Focal Dystonia by a neurologist
No contraindications to TMS or TDCS (head injury, epilepsy, implanted devices, some medications)
No other neurological or musculoskeletal disorder affecting the dystonic region
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Condtraindications to TMS or TDCS
Musculoskeletal or neurological disorders other than primay focal dystonia affecting the body part
Secondary Dystonia (eg after stroke or Parkinsons Disease)
Generalised Dystonia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Each patient is age and gender matched to a healthy control who will undergo the exact same procedures.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
20/03/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
16
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
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5041
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Recruitment postcode(s) [2]
5132
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5042
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Recruitment postcode(s) [3]
5133
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5052
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Recruitment postcode(s) [4]
5134
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5051
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Recruitment postcode(s) [5]
5135
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5062
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Recruitment postcode(s) [6]
5136
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5034
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Recruitment postcode(s) [7]
5137
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5063
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Recruitment postcode(s) [8]
5138
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5159
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Recruitment postcode(s) [9]
5139
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5034
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Recruitment postcode(s) [10]
5140
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5061
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Recruitment postcode(s) [11]
5141
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5171
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Recruitment postcode(s) [12]
5142
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5039
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Recruitment postcode(s) [13]
5143
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5168
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Recruitment postcode(s) [14]
5144
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5048
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Recruitment postcode(s) [15]
5145
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5163
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Recruitment postcode(s) [16]
5146
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5167
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Recruitment postcode(s) [17]
5147
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5173
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Recruitment postcode(s) [18]
5148
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5047
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Recruitment postcode(s) [19]
5149
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5000
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Brain Foundation of Australia
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Address [1]
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Suite 21 Regent House
37-43 Alexander Street
Crows Nest NSW 2065
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Lynley Bradnam
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Address
Health Sciences Building
Repatriation General Hospital
Daws Road
Daw Park, SA, 5041
Adelaide
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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Individual
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Name [1]
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Associate Professor Michael Ridding
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Address [1]
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Neuromotor Plasticity & Development Group
The Robinson Institute
School of Paediatrics & Reproductive Health
The University of Adelaide
Ground Floor, Norwich Centre
55 King William Road
North Adelaide
SA 5006 Australia
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
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Southern Adelaide Clinical
Human Research Ethics Committee
Southern Adelaide Health Service
Room 2A221 - Inside Human Resources
Flinders Medical Centre,
Flinders Drive
Bedford Park SA 5042
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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13/02/2012
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Ethics approval number [1]
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1/11/0445
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Summary
Brief summary
The purpose of the study is to assess whether noninvasive stimulation of the cerebellum (base of the brain) can improve the symptoms of primary focal dystonia. Dystonia is a movement disorder that may be expressed, in part, due to dysfunction of motor networks in the brain including the cerebellum. There are few treatments currently available. If stimulating this region improves dystonia then it has potential to be used as a therapeutic intervention in the future.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lynley Bradnam
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Address
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Health Sciences Building
Flinders University
Repatriation General Hospital
Daws Road
Daw Park, SA 5041
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Country
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Australia
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Phone
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+61 8 7221 8291
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Fax
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+ 61 8 8275 1138
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Email
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[email protected]
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Contact person for scientific queries
Name
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Lynley Bradnam
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Address
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Health Sciences Building
Flinders University
Repatriation General Hospital
Daws Road
Daw Park SA 5041
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Country
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Australia
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Phone
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+61 8 7221 8291
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Fax
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+ 61 8 8275 1138
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Email
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[email protected]
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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
No additional documents have been identified.
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