Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001105437
Ethics application status
Approved
Date submitted
22/03/2016
Date registered
16/08/2016
Date last updated
16/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Noninvasive brain stimulation and it's effects on balance and proprioception in Parkinson's disease
Scientific title
Combining high definition transcranial direct current stimulation with motor training and it's effects on early to midstages Parkinson's Disease symptoms
Secondary ID [1] 288821 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 298094 0
Condition category
Condition code
Neurological 298259 298259 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 298585 298585 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High definition transcranial direct current stimulation (HD tDCS) + Proprioceptive training. 15 minutes of active anodal stimulation at 1.5mA over the motor cortex, directly followed by 30 minutes of proprioceptive and balance training. These sessions will be run 3 times a week for 4 weeks. The exercises were novel, developed by a team of specialist physiotherapists and based on daily household activities like reaching. The stimulation and exercises were delivered by the primary investigator, a PhD candidate in the Faculty of Health with a background in neuroscience. All sessions in this intervention are one-on-one and take place in a laboratory setting at the University of Canberra. The study runs for 8 weeks, with three sessions of stimulation/exercise per week, and one fortnightly baseline measures session. The wash out period is two weeks, this does not have to be longer due none of the treatments being continued across both sessions and progress can be compared to baseline measures taken before interventions.
Intervention code [1] 294274 0
Rehabilitation
Intervention code [2] 294561 0
Treatment: Devices
Intervention code [3] 294562 0
Diagnosis / Prognosis
Comparator / control treatment
It was a cross over study, for another 4 weeks the participant received sham stimulation which followed the exact same process to have the electrode cap applied, The activation ramps up to 1.5mA and then immediately returns to baseline where it sits for the remainder of the 15mins, producing a very convincing sham condition. This is the immediately followed this with 30 minutes of handwriting practice and cognitive training. Each week a different set of sentences is provided to the participant to copy out onto handwriting paper, and they are given tips on how to improve their style (approx. 15 mins). They also complete cognitive training tasks on a computer using the Lumosity program, each session completing three games (approx. 15mins).
Control group
Placebo

Outcomes
Primary outcome [1] 297748 0
Ankle proprioception, as measured by the AMEDA (Active Movement Extent Discrimination Assessment) device. Scored were taken for both plantarflexion and inversion.
Timepoint [1] 297748 0
Taken initially, at 2 weeks, 4 weeks, 6 weeks and at completion of the 8 week trial.
Primary outcome [2] 297749 0
Balance, as measured by the Mini BEST
Timepoint [2] 297749 0
Taken initially, at 2 weeks, 4 weeks, 6 weeks and at completion of the 8 week trial.
Secondary outcome [1] 322119 0
Parkinson's symptoms, measured by the Parkinson's Disease Questionnaire 39
Timepoint [1] 322119 0
Taken initially, at 2 weeks, 4 weeks, 6 weeks and at completion of the 8 week trial.
Secondary outcome [2] 322120 0
Falls efficacy, measured by the Falls Efficacy Scale questionnaire.
Timepoint [2] 322120 0
Taken initially, at 2 weeks, 4 weeks, 6 weeks and at completion of the 8 week trial.

Eligibility
Key inclusion criteria
Diagnosis of Parkinson's Disease by a neurologist, over 40 years of age at diagnosis, able to walk independently (with stick or a frame accepted),
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Early onset Parkinson's, late stages Parkinson's, atypical Parkinson's, history of other neurological disease/s, history of severe ankle injury.

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)
Allocated to intervention groups by unrelated 3rd party and placed in plain envelopes to be opened upon first session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/07/2015
Date of last participant enrolment
Anticipated
28/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 293178 0
University
Name [1] 293178 0
University of Canberra
Country [1] 293178 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Haydon Drive
Bruce ACT 2616
Country
Australia
Secondary sponsor category [1] 291972 0
None
Name [1] 291972 0
Address [1] 291972 0
Country [1] 291972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294670 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 294670 0
Ethics committee country [1] 294670 0
Australia
Date submitted for ethics approval [1] 294670 0
13/05/2015
Approval date [1] 294670 0
01/06/2015
Ethics approval number [1] 294670 0
HREC 15-113

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

Contacts
Principal investigator
Name 64586 0
Ms Hayley Teasdale
Address 64586 0
Room 12B40
University of Canberra
Haydon Drive Bruce
ACT 2617
Country 64586 0
Australia
Phone 64586 0
+61 432822191
Fax 64586 0
Email 64586 0
[email protected]
Contact person for public queries
Name 64587 0
Hayley Teasdale
Address 64587 0
Room 12B40
University of Canberra
Haydon Drive Bruce
ACT 2617
Country 64587 0
Australia
Phone 64587 0
+61 432822191
Fax 64587 0
Email 64587 0
[email protected]
Contact person for scientific queries
Name 64588 0
Hayley Teasdale
Address 64588 0
Room 12B40
University of Canberra
Haydon Drive Bruce
ACT 2617
Country 64588 0
Australia
Phone 64588 0
+61 432822191
Fax 64588 0
Email 64588 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
No additional documents have been identified.