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Trial registered on ANZCTR


Registration number
ACTRN12624000516583
Ethics application status
Approved
Date submitted
4/04/2024
Date registered
26/04/2024
Date last updated
26/04/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating Safety and Effectiveness of a Peripheral Stimulation Device
Scientific title
Investigating Safety and Effectiveness of a Peripheral Stimulation Device in healthy adults
Secondary ID [1] 311746 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 333233 0
Condition category
Condition code
Neurological 329921 329921 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be seated in a comfortable chair with their feet on a foot stool. Stimulation will be applied to the soles of the feet or toes. During stimulation, brain activity will be recorded using a non-invasive brain imaging technique such as electroencephalography (EEG) or functional near-infrared spectroscopy (fNIRS) to ensure stimulation is targeting the appropriate somatosensory receptors and carrying information to the brain. Participants will be asked about perception of stimulation (whether they perceive it or not), and the level of discomfort using a visual analogue scale. Participants will complete a single visit lasting 2-3 hours. During their visit, they will undergo two types of stimulation (electrical and vibrotactile) with a 30-minute wash out period in-between. Each stimulation type will be applied in pulses for 30-45 minutes. The order of which stimulation type (i.e., electrical or vibrotactile) a participant receives first is counterbalanced. Further details of the stimulation hardware and brain imaging is provided below.

Stimulation & brain imaging:
The stimulation devices will be programmed to achieve stimulation with certain patterns and parameters (e.g., pulse width and frequency) reported in studies such as those using coordinated reset stimulation (CRS) applied to the fingers.

a) For electrical stimulation, a custom-built device will be used to deliver electrical pulses via electrodes attached to the participant's skin. The current delivered will be up to a maximum of 4.5 mA (depending on the level perceived by participants). This is less than the currents delivered by commercially available transcutaneous electrical nerve stimulation (TENS) devices, which apply electrical stimulation for management of pain.

b) For vibrotactile stimulation, a commercial device, manufactured by Engineering Acoustics, with individual vibrators and a controller, will be used to deliver brief vibrations (similar to the notifications delivered by smartphones).

Both forms of stimulation will be delivered at a level that is perceivable, with pulses in the range of 50-300ms delivered every 0.3-7 seconds.

Individual motors (for vibrotactile stimulation) or electrodes (for electrical stimulation) will be placed on 4 separate sites on one foot. Each site is stimulated one at a time. The order of stimulation is randomised.

Brain activity during stimulation will be recorded using fNIRS or EEG to ensure that stimulation generates a cortical response. Both systems, with fNIRS applied first and EEG second, will be used on 3-5 healthy participants to determine which system better detects brain responses to vibrotactile stimulation. Participants will be given a 30-minute break in-between recordings. The preferred system will then be used on the remaining healthy participants. Both EEG and fNIRS recordings involve participants wearing a cap which is fitted based on a person's head circumference. EEG measures brain electrical activity using electrodes placed on the cap. fNIRS includes light sources and detectors placed on the cap and uses near-infrared light to measure changes in blood oxygen levels, from which brain activity is inferred. The Bionics Institute has both an Biosemi ActiveTwo EEG system (Biosemi, Netherlands) and a NIRScout fNIRS system (NIRx, Germany) which will be used in this study.

Data from healthy participants will be used to determine which stimulation patterns generate clear cortical responses and are comfortable for the participants. This will assist in developing a future protocol for use with individuals with Parkinson’s Disease if indicated.
Intervention code [1] 328211 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] 337709 0
Cortical activity in response to stimulation (such as presence of somatosensory evoked potentials in electroencephalogram (EEG) or changes in peak oxygenated and de-oxygenated hemoglobin levels on functional near-infrared spectroscopy (fNIRS) imaging)
Timepoint [1] 337709 0
During stimulation
Secondary outcome [1] 432921 0
Comfort/pain level < 10
Timepoint [1] 432921 0
Immediately after stimulation block

Eligibility
Key inclusion criteria
Healthy individuals
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Self-reported history of any musculoskeletal or cardiac conditions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2022
Date of last participant enrolment
Anticipated
28/12/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
45
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316078 0
Charities/Societies/Foundations
Name [1] 316078 0
Bionics Institute
Country [1] 316078 0
Australia
Funding source category [2] 316183 0
Charities/Societies/Foundations
Name [2] 316183 0
The Promobilia Foundation
Country [2] 316183 0
Sweden
Primary sponsor type
Charities/Societies/Foundations
Name
Bionics Institute
Address
Country
Australia
Secondary sponsor category [1] 318260 0
None
Name [1] 318260 0
Address [1] 318260 0
Country [1] 318260 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314897 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314897 0
Ethics committee country [1] 314897 0
Australia
Date submitted for ethics approval [1] 314897 0
10/12/2021
Approval date [1] 314897 0
21/01/2022
Ethics approval number [1] 314897 0
282/21

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

Contacts
Principal investigator
Name 133086 0
Dr Mehrnaz Shoushtarian
Address 133086 0
Bionics Institute, 384-388 Albert Street, East Melbourne, VIC, 3022
Country 133086 0
Australia
Phone 133086 0
+61 3 9667 7523
Fax 133086 0
Email 133086 0
mshoushtarian@bionicsinstitute.org
Contact person for public queries
Name 133087 0
Mehrnaz Shoushtarian
Address 133087 0
Bionics Institute, 384-388 Albert Street, East Melbourne, VIC, 3022
Country 133087 0
Australia
Phone 133087 0
+61 3 9667 7523
Fax 133087 0
Email 133087 0
gait_study@bionicsinstitute.org
Contact person for scientific queries
Name 133088 0
Mehrnaz Shoushtarian
Address 133088 0
384-388 Albert Street
Country 133088 0
Australia
Phone 133088 0
+61 3 9667 7523
Fax 133088 0
Email 133088 0
mshoushtarian@bionicsinstitute.org

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?

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.