Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000148976
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
12/02/2020
Date last updated
12/02/2020
Date data sharing statement initially provided
12/02/2020
Date results provided
12/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects Of Brain Stimulation On Balance Control In Parkinson's Disease
Scientific title
The Effects Of Transcranial Direct Current Stimulation (tDCS) On Balance Control In Parkinson's Disease (PD)
Secondary ID [1] 300127 0
None
Universal Trial Number (UTN)
U1111-1245-5916
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 315655 0
Condition category
Condition code
Neurological 313946 313946 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A constant transcranial direct current stimulation (tDCS) is delivered using a battery-driven stimulator (DC-StimulatorPlusTM, NeuroConn, Ilmenau, Germany) with anodal (5 × 7 cm2), and cathodal (10 × 10 cm2) water-soaked sponge electrodes with an intensity of 1 mA during 20 min over 4 sessions. The anode electrode is placed over the left dorsolateral prefrontal cortex (LDLPFC), corresponding to F3 in the 10-20 EEG system. The cathode electrode is placed over the right orbitofrontal cortex. Two straps is used to affix the electrodes. A fitted head cap (Artinis Medical Systems, The Netherlands) is applied to keep the electrodes in place and to assure that the electrodes have full contact to the scalp. This method of LDLPFC localization has been used before in several tDCS studies on cognitive function, and motor function, which has been regarded as a relatively accurate method of localization by neuroimaging techniques.

For real stimulation, constant current is increased to 1 mA in a ramp-like fashion over 15 seconds, holds constant at 1 mA for 19 mins and 30 seconds, and then decreases over 15 seconds. Sham stimulation included 15 seconds of ramping the stimulation up to 1 mA and then immediately down again at the beginning and the end of intervention; this is to control for the participants physical sense of stimulation associated with current changes. This design is a reliable control as sensations resulting from tDCS become negligible after the initial minute of stimulation.

The tDCS intervention is administered by a PhD candidate. Each participant attends four sessions, which including real tDCS with firm standing, real tDCS with foam standing, sham tDCS with firm standing and sham tDCS with foam standing. Under the firm standing condition, participants are instructed to stand directly on the platform with both feet hip width apart and focus on their balance. When participants under the foam standing, they are demonstrated to position themselves in the centre of medium density foam block (74.5cm x 62cm x 15.7cm) (Qiu, Cole et al. 2013). In order to monitor fidelity to the intervention, another investigator is onsite during the tDCS stimulation. Prior to the tDCS stimulation, participants are informed the study protocol. Participants are allowed to inform investigator if they need extra rest or are willing to stop from participating during each session.

The study has been designed as a cross over study and the interval between tDCS sessions is seven days, as this interval has been used in previous tDCS studies to effectively wash out any potential after effects (Fregni, Boggio et al. 2005, Fregni, Gimenes et al. 2006, Vanderhasselt, De Raedt et al. 2013).
Intervention code [1] 316400 0
Treatment: Devices
Comparator / control treatment
This study has a randomized, double blind, cross-over design.
The participants with and without Parkinson's disease (PD) receive two active-tDCS (real tDCS stimulation) and two sham-tDCS (placebo stimulation) over four sessions. The current in both active- and sham-tDCS will be increased to 1mA over 15 sec. In active-tDCS condtion the current is held constant at 1 mA for 20 minutes and in sham-tDCS the current is stopped. After 20 minutes both conditions receive decreasing current from 1mA to zero over 15 sec at the end of the session. Thus, in both conditions participants feel the stimulation at the fist and last 15 second of the stimulation session. We compare the results of active tDCS sessions versus sham-tDCS of the same participants. Thus, they are their own controls in this design.
Control group
Placebo

Outcomes
Primary outcome [1] 322342 0
Postural stability under stable and unstable standing conditions using a force plate (HUR Labs, OY, Finland) is the composite outcome. Under the stable standing condition, participants are instructed to stand directly on the platform with both feet hip width apart and focus on their balance. When participants under the unstable standing, they are demonstrated to position themselves in the centre of medium density foam block (74.5cm x 62cm x 15.7cm) (Qiu, Cole et al. 2013).
Timepoint [1] 322342 0
Transracial Direct Current Stimulation (tDCS) is applied over four sessions. Centre of pressures (COP) is assessed at 12 time points. Each tDCS session consists of 3 time points, which including 1 time point prior to possible tDCS stimulation, 1 time point during stimulation and 1 time point immediately after the stimulation. The time points prior to and after stimulation last for 6 minutes each, and the time point during stimulation consists of two blocks, each block lasts for 6 minutes. There is a 3 minutes rest between these two blocks. COP is measured immediately before, during and immediately after applying tDCS in all four sessions.
Primary outcome [2] 322343 0
Cerebral hemodynamic activation before and after tDCS using an OxysoftTM (Artinis Medical Systems, The Netherlands) Functional Near-infrared Spectroscopy (fNIRS) device, which is a composite outcome.
Timepoint [2] 322343 0
Transracial Direct Current Stimulation (tDCS) is applied over four sessions. Oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) as the measure of cerebral hemodynamic is assessed at 8 time points. Cerebral hemodynamic change is measured immediately before and after applying tDCS in all four sessions. Each tDCS session consists of 2 time points, the first time point starts before tDCS and lasts for 6 minutes, the second time point starts immediately after tDCS and lasts for 6 minutes.
Secondary outcome [1] 378162 0
Systemic control including blood pressure, heart rate and respiration is collected in synchrony with the fNIRS measurement, and converts from analogue to digital signal (ADInstruments, Dunedin, New Zealand), and the outcome is composite.
Timepoint [1] 378162 0
Transracial Direct Current Stimulation (tDCS) is applied over four sessions. Blood pressure, heart rate and respiration change as the measure of systemic control is assessed at 8 time points. systemic control is measured immediately before and after applying tDCS in all four sessions. Each tDCS session consists of 2 time points, the first time point starts before tDCS and lasts for 6 minutes, the second time point starts immediately after tDCS and lasts for 6 minutes.
Secondary outcome [2] 378163 0
Adverse effects resulted from tDCS.

A comprehensive assessment of adverse effects (i.e., headache, neck and scalp pain, tingling, itching, burning, sleepiness, problems concentrating) was conducted before and after each tDCS session. Participants were also asked to assess how likely these adverse effects were related to tDCS, and it was rated pm a scale from 1 to 5 (1 = None, 2 = Remote, 3 = Possible, 4 = Probable and 5 = Definite) (Brunoni, Amadera et al. 2011).
Timepoint [2] 378163 0
These comprehensive assessment of adverse effects and mood change is conducted before and after each tDCS session.
Secondary outcome [3] 379510 0
Mood was self-evaluated with the Visual Analogue Mood Scales (VAMS) immediately before and after each session (Folstein and Luria 1973). The VAMS assesses both positive (N=2) which including energetic and happy, and negative mood (N=6), which including confused, sad, angry, tired and tense, using 8 scales (range 0-100) including energetic, happy, afraid, confused, sad, tired, angry and tense. Higher values indicate more positive or negative mood ratings.
Timepoint [3] 379510 0
These comprehensive assessment of adverse effects and mood change is conducted before and after each tDCS session.

Eligibility
Key inclusion criteria
1) Be naturally right handed.
2) Be reasonably fluent in English.
3) Have normal or corrected-to normal vision, and without hearing problems.
4) Have no previous brain surgery, have no implants to your head (cochlear implants, aneurysm clips, brain electrodes).
5) Live independently in the community, and to be able to walk independently without the use of aids.

Additionally, potential participants have Parkinson's disease should also meet the following inclusion criteria:
1) Have to be diagnosed with PD but no other neurological disorder.
2) Have to have a Hoehn & Yahr (H&Y) score less than or equal to 3.
3) Have to be able to ambulate without assistance.
4) Doesn't have surgical treatment for Parkinson’s disease (DBS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Recent history of cardio-vascular problems.
2) Significant cognitive impairment.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
10/08/2018
Date of last data collection
Anticipated
Actual
31/08/2018
Sample size
Target
72
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 28896 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 304567 0
University
Name [1] 304567 0
Queensland University of Technology
Country [1] 304567 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Avenue, Kelvin Grove, Brisbane, QLD 4059
Country
Australia
Secondary sponsor category [1] 304849 0
None
Name [1] 304849 0
Address [1] 304849 0
Country [1] 304849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304993 0
University Human Research Ethics Committee (UHREC) at QUT
Ethics committee address [1] 304993 0
Ethics committee country [1] 304993 0
Australia
Date submitted for ethics approval [1] 304993 0
06/01/2017
Approval date [1] 304993 0
12/05/2017
Ethics approval number [1] 304993 0
1700000024

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

Contacts
Principal investigator
Name 98894 0
Miss Jing Qi
Address 98894 0
60 Musk Avenue, Queensland University of Technology, Kelvin Grove QLD 4059
Country 98894 0
Australia
Phone 98894 0
+61 04 0613 4611
Fax 98894 0
Email 98894 0
[email protected]
Contact person for public queries
Name 98895 0
Jing Qi
Address 98895 0
60 Musk Avenue, Queensland University of Technology, Kelvin Grove QLD 4059
Country 98895 0
Australia
Phone 98895 0
+61 04 0613 4611
Fax 98895 0
Email 98895 0
[email protected]
Contact person for scientific queries
Name 98896 0
Jing Qi
Address 98896 0
60 Musk Avenue, Queensland University of Technology, Kelvin Grove QLD 4059
Country 98896 0
Australia
Phone 98896 0
+61 04 0613 4611
Fax 98896 0
Email 98896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6221Informed consent form    378959-(Uploaded-17-12-2019-18-33-04)-Study-related document.docx
6222Ethical approval    378959-(Uploaded-16-01-2020-16-31-20)-Study-related document.docx



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.