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Trial registered on ANZCTR

Registration number

ACTRN12618000094279

Ethics application status

Approved

Date submitted

12/01/2018

Date registered

22/01/2018

Date last updated

22/01/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of non-invasive brain stimulation on motor re-learning in people with chronic stroke

Scientific title

The effects of anodal cerebellar transcranial direct current stimulation on locmotor re-learning in people with chronic stroke

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1200-6805

Trial acronym

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

Haemorrhagic

Stroke

Ischaemic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study involves four sessions in total: three rehabilitation sessions on a treadmill using transcranial direct current stimulation (tDCS) intervention over three consecutive days and one post-intervention assessment after one week. In the first session, prior to walking on the treadmill, comfortable walking speed and walking asymmetry during over-ground walking will be determined. During treadmill walking, kinematic data will be measured through computerized gait analysis that will record 3-dimensional position data from reflective markers placed on legs. The participant’s walking will be assessed during three phases: 1) baseline phase, where both the belts will move at the same speed for 2 minutes; 2) adaptation phase, where both the belts will move at different speeds for 15 minutes; and 3) de-adaptation phase, where the belts will move at same speed again for 3 minutes. During adaptation phase, tDCS intervention will be delivered by a direct current stimulator (Magstim Co, UK) via electrodes placed on the back of the head (active electrode on the cerebellum) and on the cheek (reference electrode). The current will be slowly ramped up to 2 mA over 30 seconds, held constant at 2 mA for 15 minutes and then decreased over 30 seconds at the end of the stimulation. The primary outcome measure will be step length asymmetry measured at post-intervention assessment after one week. To determine the translation of effects to over-ground walking, over-ground walking asymmetry will be assessed after three days and one week. Each session will take approximately two hours (90 minutes-assessment and setting up, 20 minutes-rehabilitation) and will be held at the Running and Cycling clinic, AUT Millennium Institute.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Devices

Comparator / control treatment

The control intervention will be carried out in the same way as the tDCS intervention, except that the participant will not recieve the tDCS stimulation (the delivery of current will stop automatically after 30 seconds). Although the control intervention uses sham tDCS stimulation, the participant will still be walking on the treadmill. Thus, the control is active.

Control group

Active

Outcomes

Primary outcome [1]

Effect of tDCS on motor learning: Step length asymmetry on the treadmill. Measured with 3-D gait analysis using force plate data.

Timepoint [1]

-Baseline phase of treadmill walking on session 1 and session 4

Primary outcome [2]

Cumulative effect of tDCS on motor learning: Step length asymmetry on the treadmill. Measured with 3-D gait analysis using force plate data.

Timepoint [2]

-Baseline phase of treadmill walking on session 1, session 2 and session3

Primary outcome [3]

Effect of tDCS on transfer of learning: Over ground step length asymmetry. Measured with 3D gait analysis using force plate data.

Timepoint [3]

-Before treadmill baseline phase on session 1 and session 4

Secondary outcome [1]

Within-session learning: Step length asymmetry on treadmill. Measured with 3D gait analysis using force plate data.

Timepoint [1]

-Baseline phase and de-adaptation phase of treadmill walking on session 1
-Baseline phase and de-adaptation phase of treadmill walking on session 2
-Baseline phase and de-adaptation phase of treadmill walking on session 3

Secondary outcome [2]

Between-session learning: Step length asymmetry on treadmill. Measured with 3D gait analysis using force plate data.

Timepoint [2]

-De-adaptation phase of treadmill walking on session 1 and baseline phase of session 2
-De-adaptation phase of treadmill walking on session 2 and baseline phase of session 3

Eligibility

Key inclusion criteria

-Single stroke causing hemiparesis affecting ability to walk
-More than 6 months post stroke

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-inability to walk for 5 minutes continuously
-cerebellar stroke
-contra-indications to transcranial direct current stimulation

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)

Following recruitment, screening and informed consent, eligible participants will be randomly allocated to either intervention or control group using a randomisation schedule generated by a computer system. This will be held by a third party.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated random allocation stratified by age, time since stroke and comfortable walking speed

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

The effect of tDCS will be assessed by a linear mixed model analysis, with one between-group independent variable as type of stimulation condition (two levels: anodal and sham) and one within-group independent variables as session (four levels: session1, session2, session3 and session4). The dependent variable will consist of mean step length asymmetry at baseline, adaptation, de-adaptation phase and overground walking. Post-hoc tests will only be calculated where the main factor or interaction are significant.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2018

Actual

Date of last participant enrolment

Anticipated

15/05/2018

Actual

Date of last data collection

Anticipated

31/05/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Auckland University of Technology

Address [1]

Private Bag 92006
Auckland 1142

Country [1]

New Zealand

Primary sponsor type

University

Name

Auckland University of Technology

Address

Private Bag 92006
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

23/08/2017

Approval date [1]

12/10/2017

Ethics approval number [1]

17/STH/147

Summary

Brief summary

This study aims to find out if passing low continuous electric currents to the cerebellum, a part of the brain at the back of the head, can speed up the acquisition of a lower limb motor task in people with chronic stroke. As the cerebellum plays a major role in adapting and fine tuning movements through a trial and error process, application of non-invasive transcranial direct current stimulation (tDCS) to the cerebellum has been identified as one potential method of promoting motor learning. Research demonstrates that single session of transcranial direct current stimulation (tDCS), when applied to the cerebellum, increases the rate and amount of motor learning in healthy individuals, however, little is known about its effects in people with stroke.
A randomised controlled trial is proposed, where 6 month post-stroke participants will receive the stimulation as they learn to adapt their walking pattern in response to a treadmill that forces one leg to move faster than the other. The participants will be randomised to receive either real anodal tDCS or sham tDCS. A computerised gait analysis system will record their walking on the treadmill which will be used to calculate the primary outcome i.e step length asymmetry. We hypothesize that application of anodal tDCS will result in greater motor learning as compared to the sham stimulation.This information will facilitate the development of novel neuromodulatory interventions that could be used in rehabilitation to reduce the time spent re-learning other motor skills.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nada Signal

Address

Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x 7062

Fax

nada.signal@aut.ac.nz

Contact person for public queries

Name

Nada Signal

Address

Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x 7062

Fax

nada.signal@aut.ac.nz

Contact person for scientific queries

Name

Denise Taylor

Address

Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9680

Fax

denise.taylor@aut.ac.nz

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	Cerebellar transcranial direct current stimulation for motor learning in people with chronic stroke: A pilot randomized controlled trial.	2020	https://dx.doi.org/10.3390/brainsci10120982

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

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Documents added automatically