Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001471572
Ethics application status
Approved
Date submitted
25/11/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A longitudinal study to investigate the learning effect of virtual reality-based brain-computer interface training on motor imagery signals in unimpaired individuals
Scientific title
The effect of longitudinal virtual reality mediated brain-computer interface (BCI) training on sensorimotor neuromodulation and BCI control in unimpaired individuals
Secondary ID [1] 313458 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unimpaired individuals 335859 0
Neurorehabilitation 335860 0
Condition category
Condition code
Neurological 332439 332439 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 332440 332440 0 0
Other physical medicine / rehabilitation
Neurological 332564 332564 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual reality brain-computer interface (VR-BCI) Training
Seven healthy, right-handed volunteers (2 females, aged 24-40) participated in this study. None had any medical conditions like pregnancy, claustrophobia, drug addiction, or neurological diseases that could interfere with the tasks. Each person completed 15 training sessions, held on different days, with no more than three sessions per week.
All sessions were administered by one of the researcher from the team. All participants received exactly the same tasks throughout the intervention.

The study followed ethical guidelines, was approved by Griffith University’s research ethics board, and all participants gave written consent before joining.

During each session, participants sat comfortably while wearing an electroencephalogram (EEG) headset to measure brain activity and a virtual reality (VR) headset for the tasks. They practiced two types of mental exercises: imagining themselves walking or relaxing. Each session included three phases: calibration, cued-online with feedback, and using the system freely without cues. Breaks of 1-3 minutes were given between phases, depending on the participant's readiness. Each session, including setup, took about an hour and was conducted in Griffith University’s Physiotherapy Laboratory (G02_1.17).
Intervention code [1] 330030 0
Rehabilitation
Intervention code [2] 330031 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339982 0
Change in the ability of the participant to control the brain-computer interface system.
Timepoint [1] 339982 0
after the first three training sessions and last three training sessions
Primary outcome [2] 339983 0
Electroencephalogram (EEG) signal separability
Timepoint [2] 339983 0
After first three training sessions and last three training sessions
Primary outcome [3] 340129 0
Electroencephalogram (EEG) signal separability
Timepoint [3] 340129 0
After first three training sessions and last three training sessions
Secondary outcome [1] 442190 0
Correlation between classification accuracy and self-prediction
Timepoint [1] 442190 0
At the start and end of each session

Eligibility
Key inclusion criteria
Following factors were considered/recorded for selecting participants for the study:
1. Healthy with no prior illnesses,
2. Participants should have a normal or corrected-to-normal vision.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Following factors were considered for rejecting a participant for the study:
1. Pregnancy
2. Claustrophobia
3. Drug addiction
4. Neurological diseases

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants for this study was determined based on prior studies in brain-computer interface (BCI) research and virtual reality (VR)-based rehabilitation, which typically involve small sample sizes (5–10 participants) for exploratory and longitudinal investigations. The focus was on feasibility and observing significant trends in learning motor imagery (MI) control over multiple sessions. Participants were recruited to represent a sufficient sample for detecting individual changes in BCI performance and sensorimotor neuromodulation through repeated measures analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2021
Date of last participant enrolment
Anticipated
Actual
24/03/2021
Date of last data collection
Anticipated
Actual
7/09/2021
Sample size
Target
7
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317894 0
Government body
Name [1] 317894 0
Queensland Motor Accident Insurance Commission (MAIC)
Country [1] 317894 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320238 0
None
Name [1] 320238 0
Address [1] 320238 0
Country [1] 320238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316582 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316582 0
Ethics committee country [1] 316582 0
Australia
Date submitted for ethics approval [1] 316582 0
24/02/2021
Approval date [1] 316582 0
21/03/2021
Ethics approval number [1] 316582 0
GU ref no: 2021/170

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

Contacts
Principal investigator
Name 138314 0
Dr Malik Muhammad Naeem Mannan
Address 138314 0
Room 2.09, Building G02, Gold Coast Campus, Griffith University, 1 Parklands Dr, Southport QLD 4215
Country 138314 0
Australia
Phone 138314 0
+61 756780576
Fax 138314 0
Email 138314 0
[email protected]
Contact person for public queries
Name 138315 0
Malik Muhammad Naeem Mannan
Address 138315 0
Room 2.09, Building G02, Gold Coast Campus, Griffith University, 1 Parklands Dr, Southport QLD 4215
Country 138315 0
Australia
Phone 138315 0
+61 756780576
Fax 138315 0
Email 138315 0
[email protected]
Contact person for scientific queries
Name 138316 0
Malik Muhammad Naeem Mannan
Address 138316 0
Room 2.09, Building G02, Gold Coast Campus, Griffith University, 1 Parklands Dr, Southport QLD 4215
Country 138316 0
Australia
Phone 138316 0
+61 756780576
Fax 138316 0
Email 138316 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Access to IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Conditions for requesting access:
• -

What individual participant data might be shared?
• Raw de-identified electroencephalography data acquired at during the study.

What types of analyses could be done with individual participant data?
• Data will be made available for meta analyses and other scientific studies developing algorithms to improve brain-computer interfaces.

When can requests for individual participant data be made (start and end dates)?
From:
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Data can be obtained upon email request to the principal investigator. Please contact Dr Malik Muhammad Naeem Mannan by emailing [email protected]

Are there extra considerations when requesting access to 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.