Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000063213
Ethics application status
Approved
Date submitted
29/12/2017
Date registered
17/01/2018
Date last updated
26/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of transcranial direct current stimulation (tDCS) on gait
in people with Parkinson's disease (PD)
Scientific title
Effects of transcranial direct current stimulation (tDCS) on gait
in people with Parkinson's disease (PD)
Secondary ID [1] 293672 0
Nil Known
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 306026 0
Condition category
Condition code
Neurological 305178 305178 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation approach now widely used in neuroscientific and clinical research in humans It has an excellent safety profile and is a low cost technique that is easy to administer in double-blind clinical trials. TDCS modulates cortical excitability via a weak direct current that is delivered by two or more scalp affixed electrodes. Anodal tDCS (a-tDCs) increases cortical excitability and cathodal tDCS (c-tDCs) decreases it. The underlying mechanisms by which tDCS modulates neurophysiology and behaviour are not yet fully understood. However, it is thought that acute effects of a single session of 20 second tDCS last for at least 24 hours. Further, the effects of 5-10 sessions of tDCS play a key role in neuroplasticity underlying adaptive human behaviour and learning.
In this study, tDCS will be delivered using a battery driven NeuroConn DC stimulator. A trained researcher (the PhD student) will deliver the brain stimulation in three face-to face sessions at Institute of Health and Biomedical Innovation at Queensland University of Technology. Each participant will undergo active a-tDCS and sham-tDCS (placebo) over three sessions with two weeks interval to minimize carry-over effects. A central anode electrode will be placed over the motor strip during treadmill walking in all three sessions. Two cathode electrodes (either 10×10/4×4 cm2) will be placed over the cerebellum. The order of the cathode electrodes in two active tDCS sessions will be counterbalanced across the participants. Thus, one third of the participants will receive active tDCS with a large cathode first; and another one third of the participants will receive active tDCS with a small cathode electrode firs; the final third of the participants will receive a sham-tDCS (placebo) with either a small or large cathode electrode. In sham condition, 50% of participants will have a large cathode electrode and 50% will have a small cathode electrode.
Electrodes will be inserted in saline-soaked sponge electrodes. An EASY-cap and a strap will be used to attach the electrodes over the target locations. The current will be increased to 1mA over 10 sec, held constant at 1 mA for 20 minutes and then decreased over 10 sec at the end of the stimulation. During administration of tDCS all participants will be asked to walk on treadmill (Nautilus treadmill) for 20 minutes at their self-selected comfortable speed. The severity of adverse effects will be assessed using a scale suggested by Brunoni et al. after each tDCS session.
Intervention code [1] 299948 0
Treatment: Devices
Comparator / control treatment
This study has a randomized, double blind, cross-over design.
Within subject design: The participants with Parkinson's disease (PD) receive two active-tDCS (real tDCS stimulation) and one sham-tDCS (placebo stimulation) over three sessions. The current in both active- and sham-tDCS will be increased to 1mA over 10 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 10 sec at the end of the session. Thus, in both conditions participants feel the stimulation at the fist and last 10 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] 304333 0
Gait speed using Vicon Nexus version 2.6
Timepoint [1] 304333 0
Transracial Direct Current Stimulation (tDCS) is applied over three sessions. Gait speed is assessed at 6 time points. Gait speed is measured immediately before and 15 minutes after applying tDCS in all three sessions.
Primary outcome [2] 304334 0
Muscle activity of leg muscles which involve in gait using Zerowire EMG.

The muscles include tibilais anterior, soleus, gastrocnemius medialis, gastrocnemius lateralis, rectus femoris, vastus lateralis, biceps femoris and semitendinosus
Timepoint [2] 304334 0
Transracial Direct Current Stimulation (tDCS) is applied over three sessions. Muscle activity is assessed at 6 time points. Muscle activity is measured immediately before and 15 minutes after applying tDCS in all three sessions.
Secondary outcome [1] 341613 0
stride length is assessed at 6 time points. Stride length is measured immediately before and 15 minutes after applying tDCS in all three sessions using Vicon Nexus System (Version 2.6).
Timepoint [1] 341613 0
Transracial Direct Current Stimulation (tDCS) is applied over three sessions. Stride length is assessed at 6 time points. Stride length is measured immediately before and 15 minutes after applying tDCS in all three sessions.

Eligibility
Key inclusion criteria
Inclusion criteria for the participants with Parkinson's diseases (PD):
1) Having diagnosis of Parkinson's
2) Walking independently for 10-15 minutes
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Being pregnant

Taking any psychoactive medications

Having: an adverse reaction to TMS/tDCS, seizure, vision impairment, vertigo, frequent falls, dizziness, any brain related neurological illness other than PD, uncontrolled blood pressure (hypotension or hypertension), any musculoskeletal disorders, functional limitations associated with osteoporosis, orthopaedic surgery within the last 12 months, brain surgery, metal implants in the head, any implanted medical device, any epileptic family members, migraines or neural trauma, unexplained loss of consciousness, serious head injury, surgery to the head, and frequent or severe headache.



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
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298292 0
University
Name [1] 298292 0
Queensland University of Technology
Country [1] 298292 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Level 6, O Block, B Wing, Room 670
Victoria Park Rd
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 297407 0
None
Name [1] 297407 0
Address [1] 297407 0
Country [1] 297407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299292 0
University Human Research Ethics Committee (UHREC) at QUT
Ethics committee address [1] 299292 0
Ethics committee country [1] 299292 0
Date submitted for ethics approval [1] 299292 0
Approval date [1] 299292 0
17/05/2016
Ethics approval number [1] 299292 0

Summary
Brief summary
Parkinson’s disease (PD) is a progressive disease, and is characterized by disabling movement problem including, gait difficulties and balance impairment. These affect activities of daily living, quality of life and increase the risk of falls that in turn lead to hospitalization and mortality. Gait difficulties and balance impairment are devastating problems in people with PD and continue to be an important topic for health professionals and scientists. Treatment for PD drug treatment as the first line of treatment and surgery for advanced stages. While surgical and pharmacological approaches to the treatment of PD can help to partially improve some gait difficulties, they do not always result in improvements. Allied health treatments are also used in treatment of PD. However, there is no firm consensus on the efficacy of these treatments. This suggests a need for additional and complementary approaches to manage gait and balance difficulties in PD. Recently transcranial direct current stimulation (tDCS) has been used extensively in neuroscience research. It has been used to improve movement and recovery in stroke and other neurologic disorders. It is considered to be safe with no serious adverse effects. Consequently this has raised interest in using tDCS as an intervention to improve movement in PD. This study proposes to undertake a randomized controlled study to investigate whether tDCS is effective in improving gait and balance in people with PD. If it is proved to be effective it may provide an alternative intervention strategy for treatment of movement complications of people with PD which hopefully could lead to improved quality of life and functional status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79934 0
Mrs Vida Alizad
Address 79934 0
Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove QLD 4059
Country 79934 0
Australia
Phone 79934 0
+61 7 3138 6304
Fax 79934 0
Email 79934 0
v.alizad@qut.edu.au
Contact person for public queries
Name 79935 0
Mrs Vida Alizad
Address 79935 0
Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove QLD 4059
Country 79935 0
Australia
Phone 79935 0
+61 7 3138 6304
Fax 79935 0
Email 79935 0
v.alizad@qut.edu.au
Contact person for scientific queries
Name 79936 0
Mrs Vida Alizad
Address 79936 0
Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove QLD 4059
Country 79936 0
Australia
Phone 79936 0
+61 7 3138 6304
Fax 79936 0
Email 79936 0
v.alizad@qut.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
SourceTitleYear of PublicationDOI
EmbaseEffects of transcranial direct current stimulation on gait in people with Parkinson's disease: Study protocol for a randomized, controlled clinical trial.2018https://dx.doi.org/10.1186/s13063-018-2982-z
N.B. These documents automatically identified may not have been verified by the study sponsor.