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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]

Nil Known

Universal Trial Number (UTN)

None

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parkinson's disease

Condition category

Condition code

Neurological

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]

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]

Gait speed using Vicon Nexus version 2.6

Timepoint [1]

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]

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]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

Queensland University of Technology

Address [1]

Level 6, O Block, B Wing, Room 670
Victoria Park Rd
Kelvin Grove QLD 4059

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University Human Research Ethics Committee (UHREC) at QUT

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

17/05/2016

Ethics approval number [1]

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

Mrs Vida Alizad

Address

Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove QLD 4059

Country

Australia

Phone

+61 7 3138 6304

Fax

v.alizad@qut.edu.au

Contact person for public queries

Name

Vida Alizad

Address

Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove QLD 4059

Country

Australia

Phone

+61 7 3138 6304

Fax

v.alizad@qut.edu.au

Contact person for scientific queries

Name

Vida Alizad

Address

Institute of Health and Biomedical Innovation (IHBI), 60 Musk Ave, Kelvin Grove QLD 4059

Country

Australia

Phone

+61 7 3138 6304

Fax

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

Source	Title	Year of Publication	DOI
Embase	Effects of transcranial direct current stimulation on gait in people with Parkinson's disease: Study protocol for a randomized, controlled clinical trial.	2018	https://dx.doi.org/10.1186/s13063-018-2982-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically