Trial Review

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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
Scientific title
Focal Dystonia treated using transcranial direct current stimulation compared to sham stimulation on neurophysioloigcal and functional measures
Secondary ID [1] 280170 0
NIL
Universal Trial Number (UTN)
U1111-1129-1432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Dystonia 286102 0
Condition category
Condition code
Neurological 286295 286295 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284499 0
Treatment: Devices
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.
Control group
Placebo

Outcomes
Primary outcome [1] 286766 0
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.
Timepoint [1] 286766 0
Immediately post treatment
Secondary outcome [1] 296606 0
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.
Timepoint [1] 296606 0
Immediately post treatment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Allocation is not concealed.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Each patient is age and gender matched to a healthy control who will undergo the exact same procedures.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5131 0
5041
Recruitment postcode(s) [2] 5132 0
5042
Recruitment postcode(s) [3] 5133 0
5052
Recruitment postcode(s) [4] 5134 0
5051
Recruitment postcode(s) [5] 5135 0
5062
Recruitment postcode(s) [6] 5136 0
5034
Recruitment postcode(s) [7] 5137 0
5063
Recruitment postcode(s) [8] 5138 0
5159
Recruitment postcode(s) [9] 5139 0
5034
Recruitment postcode(s) [10] 5140 0
5061
Recruitment postcode(s) [11] 5141 0
5171
Recruitment postcode(s) [12] 5142 0
5039
Recruitment postcode(s) [13] 5143 0
5168
Recruitment postcode(s) [14] 5144 0
5048
Recruitment postcode(s) [15] 5145 0
5163
Recruitment postcode(s) [16] 5146 0
5167
Recruitment postcode(s) [17] 5147 0
5173
Recruitment postcode(s) [18] 5148 0
5047
Recruitment postcode(s) [19] 5149 0
5000

Funding & Sponsors
Funding source category [1] 284919 0
Charities/Societies/Foundations
Name [1] 284919 0
Brain Foundation of Australia
Country [1] 284919 0
Australia
Primary sponsor type
Individual
Name
Lynley Bradnam
Address
Health Sciences Building
Repatriation General Hospital
Daws Road
Daw Park, SA, 5041
Adelaide
Country
Australia
Secondary sponsor category [1] 283794 0
None
Name [1] 283794 0
Address [1] 283794 0
Country [1] 283794 0
Other collaborator category [1] 260632 0
Individual
Name [1] 260632 0
Associate Professor Michael Ridding
Address [1] 260632 0
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
Country [1] 260632 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286919 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286919 0
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
Ethics committee country [1] 286919 0
Australia
Date submitted for ethics approval [1] 286919 0
Approval date [1] 286919 0
13/02/2012
Ethics approval number [1] 286919 0
1/11/0445

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33943 0
Address 33943 0
Country 33943 0
Phone 33943 0
Fax 33943 0
Email 33943 0
Contact person for public queries
Name 17190 0
Lynley Bradnam
Address 17190 0
Health Sciences Building
Flinders University
Repatriation General Hospital
Daws Road
Daw Park, SA 5041
Country 17190 0
Australia
Phone 17190 0
+61 8 7221 8291
Fax 17190 0
+ 61 8 8275 1138
Email 17190 0
[email protected]
Contact person for scientific queries
Name 8118 0
Lynley Bradnam
Address 8118 0
Health Sciences Building
Flinders University
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 8118 0
Australia
Phone 8118 0
+61 8 7221 8291
Fax 8118 0
+ 61 8 8275 1138
Email 8118 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

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