Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000672459
Ethics application status
Approved
Date submitted
10/06/2025
Date registered
25/06/2025
Date last updated
25/06/2025
Date data sharing statement initially provided
25/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
TarGAITed stimulation for Parkinson's disease
Scientific title
Peripheral stimulation as a treatment for Parkinson’s disease gait impairments
Secondary ID [1] 313032 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 335968 0
Condition category
Condition code
Neurological 332553 332553 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to examine the effects of non-invasive peripheral coordinated reset stimulation (peripheral CRS), administered to the feet, upon walking impairments on people with Parkinson's Disease (PD).

To do this, peripheral CRS – in the form of vibrotactile (Arm 1) or mild electrical stimulation (Arm 2) – will be applied to participants’ feet over five days. Brain imaging, gait analysis and assessments of clinical signs and symptoms will also be performed. Participants will also be re-assessed at 14- and 30-days post-application of peripheral CRS to determine if there are any long-lasting effects. All procedures will be conducted at the Monash Health Kingston Centre, Cheltenham, Victoria.

Participants will be randomised to one of the following study arms:

(1) Vibrotactile stimulation: Brief vibrations (similar to the notifications delivered by smartphones) will be delivered using a commercial device, manufactured by Engineering Acoustics. This device consists of individual motors and a controller.

(2) Electrical stimulation: Brief electrical pulses via electrodes attached to the participant's skin will be delivered using a custom-built device. The current delivered will be up to a maximum of 4.5 mA. This is less than the currents delivered by commercially available transcutaneous electrical nerve stimulation (TENS) devices, which apply electrical stimulation for management of pain.

In both study arms, stimulation will be delivered at a level that is perceivable, with pulses in the range of 50-100ms delivered every 0.5-2 seconds for 2 hours.

Individual motors (for vibrotactile stimulation) or electrodes (for electrical stimulation) will be placed on 4 separate sites on each foot. Each site is stimulated one at a time using a CRS pattern.

Participants will be seated in a comfortable chair with their feet on a foot stool whilst stimulation is being delivered. Participants will also be asked about their perception of stimulation (whether they perceive it or not), and the level of discomfort using a visual analogue scale.

Timeline of participation is described below. Each visit is estimated to take 3 to 4 hours. Twelve hours prior to each visit, participants will be asked to cease taking their PD medication. They will be allowed to resume their medication immediately after each session. Participants are also free to go about their typical day-to-day activities after each visit.

Initial assessment (Day 0): Participants will be asked to complete an initial visit to assess if the stimulation applied to their feet is reaching the brain. During this visit, a non-CRS pattern of stimulation will be applied while recording electroencephalography (EEG) to ensure cortical responses to stimulation can be seen. The type of stimulation used (i.e., vibrotactile or electrical) will depend on which study arm the participant has been randomised to.

EEG is a non-invasive brain imaging technique which measures brain electrical activity using electrodes placed on the scalp.

During this visit, participants will also be asked to complete the Gait Disorders Questionnaire (GDQ). This questionnaire is a self-report measure designed to assess walking problems in people with PD.

Stimulation days (Days 1 to 5): Individuals who show clear cortical responses to a non-CRS pattern of stimulation on Day 0, will be asked to return up to a week after the initial visit to start five consecutive days of peripheral CRS as described above.

EEG recordings, gait analysis and the Unified Parkinson’s disease rating scale (UPDRS) will be performed on Days 1, 3 and 5 prior to any peripheral CRS being administered. The GDQ will also be completed on Day 5 in addition to the aforementioned assessments.

Gait analysis is performed by asking participants to walk along a GAITRite walkway (CIR systems Inc., Clifton, NJ) – a flat, 8.3m carpeted strip with integrated sensors, that allows measurements of key gait characteristics such as stride length, stride time and velocity.

Part 2 and 3 of the UPDRS will be used to gather clinical ratings of activities of daily living and motor symptoms. Part 2 involves a questionnaire about a participant’s daily life. Part 3 involves asking the participant to perform certain movements (such as finger tapping, toe tapping, standing up from a chair and walking) while being filmed. The footage will then be scored by a clinician.

Follow-up visits (14- and 30-days post-stimulation): Participants who complied with the stimulation days will be asked to return 14- and 30-days after their last stimulation day. During these visits, EEG recordings, Gait Disorders Questionnaire, gait analysis and the UPDRS will be performed. Peripheral CRS stimulation will not be given during these days. Compliance with stimulation is defined as completing at least 3 out of the 5 CRS sessions and will be recorded using session attendance checklists.
Intervention code [1] 330132 0
Treatment: Devices
Comparator / control treatment
Vibrotactile stimulation

A commercial device, manufactured by Engineering Acoustics, with individual vibrators and a controller, will be used to deliver brief vibrotactile stimulation pulses (similar to the notifications delivered by smartphones).
Control group
Active

Outcomes
Primary outcome [1] 340702 0
Gait parameters measured by the GAITrite walkway
Timepoint [1] 340702 0
Gait analysis will be performed on Days 1, 3 and 5 prior to peripheral CRS being administered, Gait analysis will again be performed on days 14 and 30 post-completion of stimulation treatment.
Secondary outcome [1] 444824 0
Cortical activity (such as presence of somatosensory evoked potentials) in response to stimulation and changes in the power spectrum of the EEG.
Timepoint [1] 444824 0
Day 0, during application of non-CRS pattern of stimulation. Days 1, 3 and 5 prior to peripheral CRS being administered, and again on days 14 and 30 post-completion of stimulation treatment.
Secondary outcome [2] 445457 0
Unified Parkinson’s disease rating scale (UPDRS) score
Timepoint [2] 445457 0
Days 1, 3 and 5 prior to peripheral CRS being administered, and again on days 14 and 30 post-completion of stimulation treatment.
Secondary outcome [3] 445458 0
Gait Disorders Questionnaire (GDQ) score
Timepoint [3] 445458 0
On initial assessment day (Day 0) and on Day 5 prior to peripheral CRS being administered, and again on days 14 and 30 post-completion of stimulation treatment.
Secondary outcome [4] 445459 0
Discomfort level in response to stimulation
Timepoint [4] 445459 0
Immediately after any stimulation is applied on Days 0-5.

Eligibility
Key inclusion criteria
Participants with PD confirmed by a neurologist (Hoehn and Yahr severity scale 2-2.5) and gait impairments.
Patients who are appropriate to, and willing to delay morning medication.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of any musculoskeletal or cardiac conditions and other neurological condition(s) that may affect their ability to walk or follow instructions.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
16/06/2026
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27629 0
Kingston Centre - Cheltenham
Recruitment postcode(s) [1] 43802 0
3192 - Cheltenham

Funding & Sponsors
Funding source category [1] 317473 0
Charities/Societies/Foundations
Name [1] 317473 0
Bionics Insitute
Country [1] 317473 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Bionics Institute
Address
Country
Australia
Secondary sponsor category [1] 319762 0
None
Name [1] 319762 0
Address [1] 319762 0
Country [1] 319762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316189 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316189 0
Ethics committee country [1] 316189 0
Australia
Date submitted for ethics approval [1] 316189 0
19/06/2024
Approval date [1] 316189 0
10/10/2024
Ethics approval number [1] 316189 0
RES-24-0000-413A

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

Contacts
Principal investigator
Name 137074 0
Dr Anna Murphy
Address 137074 0
The Kingston Centre, 400 Warrigal Road, Cheltenham, VIC 3192
Country 137074 0
Australia
Phone 137074 0
+61 03 9265 1453
Fax 137074 0
Email 137074 0
[email protected]
Contact person for public queries
Name 137075 0
Anna Murphy
Address 137075 0
The Kingston Centre, 400 Warrigal Road, Cheltenham, VIC 3192
Country 137075 0
Australia
Phone 137075 0
+61 03 9265 1453
Fax 137075 0
Email 137075 0
[email protected]
Contact person for scientific queries
Name 137076 0
Mehrnaz Shoushtarian
Address 137076 0
Daly Wing, St Vincent's Hospital Level 7, 35 Victoria Parade Fitzroy VIC 3065
Country 137076 0
Australia
Phone 137076 0
+61 3 9667 7523
Fax 137076 0
Email 137076 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.