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Trial registered on ANZCTR


Registration number
ACTRN12623000218695
Ethics application status
Approved
Date submitted
9/02/2023
Date registered
1/03/2023
Date last updated
1/03/2023
Date data sharing statement initially provided
1/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of noisy galvanic vestibular stimulation on sensory responses in older adults.
Scientific title
The efficacy of noisy galvanic vestibular stimulation on somatosensory responses in older adults.
Secondary ID [1] 309026 0
Nil
Universal Trial Number (UTN)
U1111-1287-9837
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults 328979 0
Somatosensory responses 329074 0
Condition category
Condition code
Physical Medicine / Rehabilitation 325912 325912 0 0
Other physical medicine / rehabilitation
Neurological 326054 326054 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the baseline (pre-stimulation) measurement, the participants will receive one of the two intervention conditions for 20 minutes in a randomised order with a period of 2 to 7 days between each condition. The two conditions for interventions are as follows:
i. nGVS: The participant will receive 20 minutes of real nGVS.
ii. Control protocol (sham): The participant will receive 20 minutes sham (electrodes applied, but no stimulation is given).
Procedure: nGVS stimulation will be given through through 1X1 Galvanic vestibular stimulator (Soterix Mediacl Ltd.) The parameters set for the noisy galvanic stimulation (subthreshold) @
Waveform: Random Noise;
Intensity: 1 mA;
Polarity: Bipolar;
Durations: 20 minutes;
Mode of delivery: will be provided individually;
Number of times: It will be given once for 20 minutes;
Electrodes placement: Electrodes will be placed behind the ears on mastoid process
Intervention fidelity will be used by reading the detailed manual script of treatment manual given by Soterix Medical Ltd. and through structural training.
Person who delievers: Researcher herself who is a practising physiotherapist in New Zealand with 10 years of experience;
Location: VR lab, School of Clinical Sciences, Auckland university of Technology, Akoranga, New Zealand.
Intervention code [1] 325359 0
Treatment: Devices
Comparator / control treatment
To determine the change of sensory perception of a tactile stimulus, a single session of nGVS, will be compared with sham stimulation.

The participant will receive 20 minutes sham (electrodes applied, but no stimulation is given).
For the sham stimulation, the same parameters as in intervention nGVS will be used such as Waveform: Random Noise;
Intensity: 1 mA;
Polarity: Bipolar;
Durations: 20 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 333749 0
True positive rate (TPR) for detection of sensory electrical stimulation to the lateral foot at 90% sensory threshold

The electrical stimulation will be applied at 10% below threshold, i.e., at 90% sensory threshold for 30 times. The number of times the participant correctly identifies the stimuli will be scored out of total 30 number of trials.

To measure TPR, Digitimer device will be used.
Timepoint [1] 333749 0
The primary outcome will be assessed at three points: Baseline, 5 minutes post commencement of intervention (primary endpoint) and 5 minutes post completion of intervention.
Secondary outcome [1] 418140 0
Perceptual sensitivity (d')

Note: To measure perceptual sensitivity of the sensory process two aspects of detection performance i.e., true positive rate and false positive rate will be measured through Digitimer device.
Timepoint [1] 418140 0
The secondary outcome will be assessed at three-time points; baseline, 5 minutes after commencement of intervention and 5 minutes post completion of intervention.
Secondary outcome [2] 418141 0
Response bias (C)

Note: To measure response bias of the sensory process two aspects of detection performance i.e., true positive rate and false positive rate will be measured through Digitimer device.
Timepoint [2] 418141 0
The secondary outcome will be assessed at three-time points; baseline, 5 minutes after commencement of intervention and 5 minutes post completion of intervention.
Secondary outcome [3] 418142 0
COP sway length (Total excursion)

Note: It will be obtained from force plates, via VALD Performance Force decks dual force plate system in quite stance.
Timepoint [3] 418142 0
The secondary outcome will be assessed at three-time points; baseline, 5 minutes after commencement of intervention and 5 minutes post completion of intervention.

Eligibility
Key inclusion criteria
Adults aged 65 years and over
Right-handed
Can stand for 1 hour without any difficulty or assistance (which is divided into 3 sessions of 20 minutes standing, with 2 minutes of break in between each 20-minute period)
Willing to take part in research for two sessions
Willing to give consent to touch head and neck
Can come to AUT Lab at Akoranga campus
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed vestibular disorder or active BPPV
Fallen more than twice in the past 6 months
Any diagnosed neurological impairment
Medical conditions that are contraindicated with nGVS such as implants in head, neck, ankle or right foot, epilepsy, cardiac arrhythmias, unexplained recurring headaches, diabetic neuropathy
Medical conditions that are cautioned with electrical pheripheral stimulation of the foot such as metal implants in the area, skin lesions
Medical conditions that might affect the testing such as such as speech dysfunction, cognitive impairment
Any allergic skin reaction to sticking plasters as a similar substance is used in the foot electrodes and to fix the nGVS electrodes

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)
The randomised order of conditions will be determined by a computer-generated randomisation sequence (with balanced allocation to intervention and sham conditions).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Double blinded repeated measures crossover design. Each participant will receive each of the interventions, at least 48 hours apart within 2-7 days gap between the sessions in a randomised order.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The SSDT results will be analysed using Signal detection analysis (Macmillam et al., 1991). The number of HITS (number of stimulus-present trials in which participant will say ‘YES’), FALSE ALARMS (number of stimulus-absent catch trials in which participants will say ‘YES’), MISSES (number of stimulus-present trials in which participant will say ‘NO’) and CORRECT REJECTIONS (number of stimulus-absent catch trials in which participant said ‘NO’) will be considered.
Further, a mixed between within subjects’ analysis of variance (ANOVA) will be conducted to assess the impact of two different interventions (nGVS and sham) on the participant’s scores of perceptual sensitivity d’ and response bias (C) across three timepoints (Pre intervention, during intervention and post intervention). The normative check will be conducted using distribution before proceeding for ANOVA. A longitudinal analysis of covariance will be conducted to evaluate the primary null hypothesis that the true positive rate is equal across the two conditions. For this purpose, a linear mixed regression model will be constructed. The model will be estimated post-intervention outcomes while adjusting for the pre-intervention outcomes. To account for repeat measures from the same participants, the model estimation will be done as a participant-wise random intercept. The null hypothesis will be tested by statistically comparing the model-estimated post-intervention means using t-tests. The statistical significance level will be set at 0.05. These means and their differences will be reported along with their 95% confidence intervals

A statistical analysis will be carried out using SPSS software. Data from each outcome measure will be analysed using two-way repeated measures ANOVA and post hoc t-tests to explore main effects and interactions.

Complete citation: Macmillan, N. A., & Creelman, C. D. (2004). Detection theory: A user's guide. Psychology press.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/01/2023
Date of last participant enrolment
Anticipated
14/04/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
27
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 25248 0
New Zealand
State/province [1] 25248 0
Auckland

Funding & Sponsors
Funding source category [1] 313127 0
University
Name [1] 313127 0
Auckland University of Technology
Country [1] 313127 0
New Zealand
Funding source category [2] 313181 0
Charities/Societies/Foundations
Name [2] 313181 0
Eisdell Moore Centre, The Hearing Foundation, University of Auckland , New Zealand
Country [2] 313181 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
90 Akoranga Drive, Northcote, Auckland 0627
New Zealand
Country
New Zealand
Secondary sponsor category [1] 314828 0
Charities/Societies/Foundations
Name [1] 314828 0
Eisdell Moore Centre, The Hearing Foundation, University of Auckland , New Zealand
Address [1] 314828 0
School of Population Health
Building 507, Grafton Campus
Park Road, Grafton
Auckland, New Zealand
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 314828 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312372 0
AUT Ethics Committee
Ethics committee address [1] 312372 0
Auckland University of Technology
90 Akoranga Drive, Northcote, Auckland 0627
New Zealand
Ethics committee country [1] 312372 0
New Zealand
Date submitted for ethics approval [1] 312372 0
24/11/2022
Approval date [1] 312372 0
13/12/2022
Ethics approval number [1] 312372 0
21/91

Summary
Brief summary
We want to understand how the sensory information from the foot and information from the inner ear (vestibular system) work together to help us keep balanced on our feet. In this study we are adding an extra stimulation to the inner ear to see if this affects balance. The stimulation we are adding is called noisy galvanic vestibular stimulation (nGVS).
Galvanic vestibular stimulation (GVS) has been used for over 100 years to investigate balance and is a safe method. In our study we are using a particular form of GVS called nGVS, in which a weak stimulus that is not usually felt or heard is used.
The aim of this study is to determine whether nGVS changes the sensory perception of tactile stimulus in healthy older adults i.e., how well a person feels sensory inputs in the foot. Also, determine whether change in sensory perception alters COP sway length.
The results of this study will provide a greater understanding of the effects of nGVS on balance in future, the study may help in developing a new treatment using nGVS for people with poor balance. The findings of this research may be used for academic publications and presentations in various research journals or conferences.
Trial website
Trial related presentations / publications
Public notes
The original AUTEC Ethics approval was done on 27/08/2021, however after conducting and completing the study on healthy young adults, we are extending our study on healthy older adults, for which the AUTEC ethics application was submitted on 24/11/2022. The approval was given on 13/12/2022, therefore, we have mentioned 13/12/2022 as an approval date for our study on healthy older adults.

Contacts
Principal investigator
Name 124422 0
Mrs Preet Kamal Kaur
Address 124422 0
Room No. AB115
90 Akoranga Drive, Northcote, Auckland 0627
Auckland University of Technology
New Zealand
Country 124422 0
New Zealand
Phone 124422 0
+64 22 4214451
Fax 124422 0
Email 124422 0
preet.kamal.kaur@aut.ac.nz
Contact person for public queries
Name 124423 0
Mrs Preet Kamal Kaur
Address 124423 0
Room No. AB115
90 Akoranga Drive, Northcote, Auckland 0627
Auckland University of Technology
New Zealand
Country 124423 0
New Zealand
Phone 124423 0
+64 224214451
Fax 124423 0
Email 124423 0
preet.kamal.kaur@aut.ac.nz
Contact person for scientific queries
Name 124424 0
Mrs Preet Kamal Kaur
Address 124424 0
Room No. AB115
90 Akoranga Drive, Northcote, Auckland 0627
Auckland University of Technology
New Zealand
Country 124424 0
New Zealand
Phone 124424 0
+6422 4214451
Fax 124424 0
Email 124424 0
preet.kamal.kaur@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethical approval from AUTEC to share the data and from the sponsors.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18309Study protocol  preet.kamal.kaur@aut.ac.nz 385341-(Uploaded-09-02-2023-13-55-45)-Study-related document.pdf
18310Statistical analysis plan  preet.kamal.kaur@aut.ac.nz It is given in the study protocol document attache... [More Details]
18311Ethical approval  preet.kamal.kaur@aut.ac.nz Original AUTEC ethical approval letter is attached... [More Details] 385341-(Uploaded-25-02-2023-13-49-23)-Study-related document.docx
18313Informed consent form    385341-(Uploaded-09-02-2023-13-46-17)-Study-related document.docx
18314Other    Participant Information Sheet 385341-(Uploaded-09-02-2023-13-55-45)-Study-related document.docx
18315Other  preet.kamal.kaur@aut.ac.nz Sample size estimation for the study 385341-(Uploaded-18-02-2023-13-45-55)-Study-related document.docx



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.