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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 293178 0
Name [1] 293178 0
University of Canberra
Address [1] 293178 0
Haydon Drive
Bruce ACT 2616
Country [1] 293178 0
Primary sponsor type
University of Canberra
Haydon Drive
Bruce ACT 2616
Secondary sponsor category [1] 291972 0
Name [1] 291972 0
Address [1] 291972 0
Country [1] 291972 0

Ethics approval
Ethics application status
Ethics committee name [1] 294670 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 294670 0
Haydon Drive
Bruce ACT 2616
Ethics committee country [1] 294670 0
Date submitted for ethics approval [1] 294670 0
Approval date [1] 294670 0
Ethics approval number [1] 294670 0
HREC 15-113

Brief summary
This study uses high definition, noninvasive, transcranial direct current stimulation in combination with exercises in balance and proprioception. We aim to improve performance on balance and proprioception tests in people with Parkinson's disease. As a result, we aim to see an increase in quality of life and a decrease in the risk of falls.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 64586 0
Ms Hayley Teasdale
Address 64586 0
Room 12B40
University of Canberra
Haydon Drive Bruce
ACT 2617
Country 64586 0
Phone 64586 0
+61 432822191
Fax 64586 0
Email 64586 0
Contact person for public queries
Name 64587 0
Ms Hayley Teasdale
Address 64587 0
Room 12B40
University of Canberra
Haydon Drive Bruce
ACT 2617
Country 64587 0
Phone 64587 0
+61 432822191
Fax 64587 0
Email 64587 0
Contact person for scientific queries
Name 64588 0
Ms Hayley Teasdale
Address 64588 0
Room 12B40
University of Canberra
Haydon Drive Bruce
ACT 2617
Country 64588 0
Phone 64588 0
+61 432822191
Fax 64588 0
Email 64588 0

No information has been provided regarding IPD availability
Summary results
No Results