Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000489493
Ethics application status
Approved
Date submitted
8/04/2016
Date registered
14/04/2016
Date last updated
14/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Parkinson's and Memory: The Effect of Brain Stimulation
Scientific title
Parkinson’s disease and Working Memory: The Effect of Transcranial Direct Current Stimulation
Secondary ID [1] 288933 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 298279 0
Condition category
Condition code
Neurological 298416 298416 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation is a technique that non-invasively stimulates the brain by applying electrical currents to a small region of the scalp, which transmit into the brain. For the current project, the current strength will be 2 milliamperes (mA). Two milliamps is low strength stimulation and you may feel some tingling sensations from the stimulation.

The tDCS session involves continuous stimulation at a fixed current of 2 milliamperes (mA) that is applied to the scalp, which will be delivered for 20 minutes. The intervention group will only receive a single 20 minute session of tDCS. The student researcher, Ms. Johanna Stephens, will be administering the treatment. Ms Stephens has received training in administering tDCS. In most cases tDCS poses a negligible risk. Mild tingling sensations under the electrodes during tDCS and minor headaches have been reported after stimulation and the electrodes can cause some redness on the scalp that typically last up to an hour. However, no serious adverse events have been reported. Participants will be instructed to report any discomfort they experience during the stimulation and that the stimulation will be terminated immediately if this should occur. At the completion of the tDCS, participants will be asked to complete a questionnaire regarding any side-effects they had. This will provide a record for the researcher and results are typically reported in the manuscript. Testing will be conducted at Swinburne University of Technology (Hawthorn campus).
Intervention code [1] 294403 0
Treatment: Devices
Comparator / control treatment
Half of the participants will randomly receive active stimulation and half will receive sham stimulation. Sham stimulation emits a brief current but then remains off for the remainder of the stimulation time. The stimulation session will last approximately 20 minutes. Testing will be conducted at Swinburne University of Technology (Hawthorn campus).
Control group
Placebo

Outcomes
Primary outcome [1] 297896 0
The primary outcome of the study is memory. This will be assessed using an n-back task, which is a standard research tool used to assess working memory.
Timepoint [1] 297896 0
Memory will be assessed at baseline and immediately post-stimulation.
Secondary outcome [1] 322711 0
NA
Timepoint [1] 322711 0
NA

Eligibility
Key inclusion criteria
1. Have a diagnosis of Parkinson’s disease
2. Those aged between 18 and 80 years of age
3. Have normal or corrected-to-normal vision
4. Have normal or corrected-to-normal hearing
5. Speak and understand English fluently

Normal or corrected-to-normal vision and hearing will be assessed informally by the researcher, Ms. Johanna Stephens. Participants will be asked if they need glasses/hearing aid or assistance.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently involved in any therapeutic trial
2. Previously experienced moderate or severe head injury/stroke/other neurological impairment
3. Had neurosurgery
4. Major medical illness (cardiovascular; diabetes requiring insulin; severe migraine)
5. Previous diagnosis of PTSD, personality disorder, schizophrenia and/or psychosis.
6. Anxiety disorder in the last 6 months
7. Significant psychiatric illness requiring hospitalisation
8. Major depression in the last 6 months
9. Dementia/hallucinations
10. Indication of excess alcohol abuse
11. Currently taking medications known to have a significant effect on CNS other than anti-PD medication
12. Diagnosis or special education for learning disability
13. History of epilepsy or seizure disorders
14. Metal implant in their head or body (including surgical implants, pace-makers, orthodontic braces).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293320 0
University
Name [1] 293320 0
University of Melbourne
Country [1] 293320 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 292134 0
None
Name [1] 292134 0
Address [1] 292134 0
Country [1] 292134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294790 0
Alfred Hospital
Ethics committee address [1] 294790 0
Ethics committee country [1] 294790 0
Australia
Date submitted for ethics approval [1] 294790 0
21/09/2015
Approval date [1] 294790 0
11/12/2015
Ethics approval number [1] 294790 0
484/15
Ethics committee name [2] 294791 0
University of Melbourne
Ethics committee address [2] 294791 0
Ethics committee country [2] 294791 0
Australia
Date submitted for ethics approval [2] 294791 0
05/04/2016
Approval date [2] 294791 0
Ethics approval number [2] 294791 0
Ethics committee name [3] 294792 0
Swinburne University of Technology
Ethics committee address [3] 294792 0
Ethics committee country [3] 294792 0
Australia
Date submitted for ethics approval [3] 294792 0
10/04/2016
Approval date [3] 294792 0
13/04/2016
Ethics approval number [3] 294792 0
SHR Project 2016/082

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64958 0
Dr Audrey McKinlay
Address 64958 0
The University of Melbourne
Parkville
Victoria 3052
Country 64958 0
Australia
Phone 64958 0
+613 9035 5180
Fax 64958 0
Email 64958 0
audrey.mckinlay@unimelb.edu.au
Contact person for public queries
Name 64959 0
Johanna Stephens
Address 64959 0
University of Melbourne
Parkville
Victoria 3052
Country 64959 0
Australia
Phone 64959 0
+613 9035 5180
Fax 64959 0
Email 64959 0
tdcsparkinsonsdiseasestudy@gmail.com
Contact person for scientific queries
Name 64960 0
Audrey McKinlay
Address 64960 0
University of Melbourne
Parkville
Victoria 3052
Country 64960 0
Australia
Phone 64960 0
+613 9035 5180
Fax 64960 0
Email 64960 0
audrey.mckinlay@unimelb.edu.au

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.