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Trial registered on ANZCTR


Registration number
ACTRN12619000077167p
Ethics application status
Not yet submitted
Date submitted
14/01/2019
Date registered
21/01/2019
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of non-invasive brain stimulation on pain in Parkinson's.
Scientific title
The impact of non-invasive brain stimulation (tDCS) on pain in Parkinson's.
Secondary ID [1] 297066 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 311072 0
Pain 311073 0
Condition category
Condition code
Neurological 309710 309710 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a randomised controlled trial using transcranial direct current stimulation (tDCS). Upon study entry, participants will be assigned to one of the following 2 groups:
1. Anodal (active) tDCS
2. Sham (control) tDCS

Active tDCS
Participants in the active tDCS groups (the anodal (active) group) will receive 20 minutes of constant current 1.5 mA (equivalent to 0.08 mA/cm2). Stimulation over the left dorsal lateral prefrontal cortex (DLPFC). This level is consistent with safety guidelines (Nitsche et al., 2008) and is well tolerated in those with Parkinson's Disease (PD; Lawrence et al., 2018). tDCS will be delivered by a constant current stimulator (Soterix®), which is administered using two 35 cm 2 sponge electrodes that have been soaked in saline solution. The anode electrode will be placed over F3 according to the 10-20 international system for EEG electrode placement, to stimulate the left DLPFC. The cathode (neutral) electrode will be position on the left side of the forehead. There will be a period of 30 seconds at the beginning and end of the tDCS for ramp up/down. This intervention will be administered by the project PhD student who will be fully trained on the the set-up and administration of tDCS. The intervention will be delivered face-to-face and individually.
Participants will receive 20 mins of tDCS, twice a week, for four weeks (8 sessions in total).

Intervention code [1] 313343 0
Treatment: Devices
Comparator / control treatment
Sham tDCS
Participants in the control tDCS groups (sham (control) tDCS group) will experience the 30-second ramp up/down of tDCS, but stimulation will discontinue after 30 seconds. This ensures participants are unaware that they are receiving sham tDCS.
Control group
Placebo

Outcomes
Primary outcome [1] 318672 0
Pain Ratings - as measured by the King's Parkinson's Disease Pain Scale (Chaudhuri et al, 2015).
Timepoint [1] 318672 0
1. Baseline (1 week prior to intervention) 2. Post-Intervention (1 week after intervention) [Primary Timepoint] 3. Follow-up (12 weeks after intervention)
Secondary outcome [1] 365645 0
Pain Catastrophising - as measured by the Pain Catastrophising Scale (Sullivan, Bishop, & Pivik, 1995).
Timepoint [1] 365645 0
1. Baseline (1 week prior to intervention) 2. Post-Intervention (1 week after intervention) 3. Follow-up (12 weeks after intervention)

Eligibility
Key inclusion criteria
1) Diagnosed with idiopathic PD by a neurologist or geriatrician in accordance with the United Kingdom Parkinson’s Disease Society Brain Bank Clinical (UKPDSBBC) criteria.
2) A score of 13 or above on the Telephone Interview for Cognitive Status - 30 (TISC-30) indicating informed consent can be given.
3) Must experience at least one type of pain as indicated on the King's Parkinson's Disease Pain Scale.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) A score of below 13 on the TISC-30 (see Key Inclusion criteria)
2) Recent history of brain surgery.
3) Deep Brain Stimulation (DBS) implant.
4) Active skin disease on the scalp.
5) History of migraine.
6) History of epilepsy.
7) Unstable medical condition (e.g., uncontrolled diabetes)
8) Metal implants in the head/brain.
9) Currently using a hearing aid.

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)
Randomisation by computer

The PhD student will detemine if a potential participant is eligible to participate in the study. Once determined as eligible the researcher will use a block randomisation program to allocate participants to groups. At the time of determining eligibility to participate the researcher will not know to which group the participant will be assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block Randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power analysis using G*Power (Faul et al., 2007) indicate a minimum sample size of 30 (15 per group) is required to detect a moderate effect (power = .80, a = .05)

Generalised Linear Mixed Models (GLMMs) will compare pain scores for each condition pre-intervention (T1), post-intervention (T2) and follow-up (T3). GLLMs are robust against non-normally distributed outcome variables, and include both random and fixed effects. There is one random effect (participant) and three fixed effects: Group (active tDCS vs sham tDCS), time (pre, post, follow up), and the Group x Time interaction (McCulloch, 2001).

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

Funding & Sponsors
Funding source category [1] 301637 0
University
Name [1] 301637 0
Curtin University
Address [1] 301637 0
Curtin University
Hayman Road
Bentley, WA 6102
Country [1] 301637 0
Australia
Primary sponsor type
Individual
Name
Professor Natalie Gasson
Address
School of Psychology
Curtin University
Hayman Road
Bentley, WA 6102
Country
Australia
Secondary sponsor category [1] 301343 0
Individual
Name [1] 301343 0
Dr Patrick Clarke
Address [1] 301343 0
School of Psychology
Curtin University
Hayman Road
Bentley, WA 6102
Country [1] 301343 0
Australia
Secondary sponsor category [2] 301344 0
Individual
Name [2] 301344 0
Mr Brayden Wisniewski
Address [2] 301344 0
School of Psychology
Curtin University
Hayman Road
Bentley, WA 6102
Country [2] 301344 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302360 0
Curtin Human Research Ethics Committee (HREC)
Ethics committee address [1] 302360 0
Curtin University
Hayman Road
Bentley, WA 6102
Ethics committee country [1] 302360 0
Australia
Date submitted for ethics approval [1] 302360 0
31/01/2019
Approval date [1] 302360 0
Ethics approval number [1] 302360 0

Summary
Brief summary
Pain is one of the most detrimental non-motor symptoms of Parkinson’s disease (PD), with up to 85% of people with PD experiencing pain in some form. Despite this, pain is often undiagnosed and frequently overlooked by clinicians and other healthcare professionals, leading to a lack of treatment (Ford, 2010). This study seeks to test the efficacy of a non-invasive brain stimulation technique (tDCS) for the treatment of pain. This treatment has resulted in improvement of pain in people with Multiple Sclerosis and fibromyalgia. It is hypothesised that tDCS will reduce pain in PD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89954 0
Prof Natalie Gasson
Address 89954 0
School of Psychology
Curtin University
GPO Box U1987
Perth WA 6845
Country 89954 0
Australia
Phone 89954 0
+61 8 9266 4308
Fax 89954 0
Email 89954 0
n.gasson@curtin.edu.au
Contact person for public queries
Name 89955 0
Prof Natalie Gasson
Address 89955 0
School of Psychology
Curtin University
GPO Box U1987
Perth WA 6845
Country 89955 0
Australia
Phone 89955 0
+61 8 9266 4308
Fax 89955 0
Email 89955 0
n.gasson@curtin.edu.au
Contact person for scientific queries
Name 89956 0
Prof Natalie Gasson
Address 89956 0
School of Psychology
Curtin University
GPO Box U1987
Perth WA 6845
Country 89956 0
Australia
Phone 89956 0
+61 8 9266 4308
Fax 89956 0
Email 89956 0
n.gasson@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We anticipate doing further work in this area.
What supporting documents are/will be available?
No other documents available
Summary results
No Results