A Questionnaire of Patient Perspectives of Brain Stimulation for Rehabilitation
Investigators: Clare Turnbull, Dr Brenton Hordacre, Associate Professor Tasha Stanton, Dr Rachel Milte
Participant Information Sheet - The Acceptability of Brain Stimulation: A Discrete Choice Experiment
Thank you for considering participating in this research study. This information sheet is intended to provide you with enough information to make an informed decision about your participation. If there is any aspect that is not clear to you, please discuss this with one of the investigators listed.
Background of the study
Non-Invasive Brain Stimulation (NIBS) is a form of therapy where electric or magnetic current is applied to the surface of the head to simulate underlying brain tissue. This therapy has the powerful potential to facilitate neuroplasticity, the central nervous system’s ability to reorganise and form new neural connections, which can be particularly beneficial in the case of neurological impairment.
Neurological disorders, such as stroke, Parkinson’s Disease and acquired brain injuries are estimated to affect approximately one billion people worldwide, often leading to long-term disability and requiring extensive rehabilitation. Preliminary evidence suggests that NIBS can be beneficial in these neurologically impaired populations by facilitating neuroplasticity and thus enhancing motor learning and recovery.
However, there are barriers to delivering this treatment which need to be considered. As NIBS is most commonly delivered in clinical settings under the supervision of research or clinical staff, it requires patients to transport themselves to clinics in order to receive therapy. NIBS can also be costly, given it is not currently compensated by Medicare or private health insurance. There is also the risk of side effects such as the rare induction of seizures, headaches and nausea.
While the risk of these side effects and barriers to NIBS are known, it is unclear whether neurologically impaired patients and clinicians are aware of these risks and specifically how they perceive these relative risks with respect to the potential therapeutic benefit. As responses from NIBS can be variable, it is possible that not all participants will benefit from this therapy, thus it is important to distinguish what participants are prepared to endure to reap the potential benefits of the therapy. This study aims to discover attributes of NIBS that patients and clinicians value, which may be incorporated into future protocols to ensure an accepted form of NIBS is used in the future.
You may be eligible to participate if you:
- are aged over 18 years
- are able to understand English
- are a person who has had a stroke
What will the study involve?
If you meet the inclusion criteria and agree to participate, we will invite you to complete the questionnaire. The questionnaire can be completed via online application or via face to face interviews.
Face to face interviews will be organised at the convenience of participants at their inpatient location. It is estimated that the face to face interviews will take no more than 45 minutes, with the online application taking less than half an hour.
Explanation of measurement tools and data collected:
If you agree to participate in this study, we will ask you some demographic questions to aid with data analysis. This will include age, gender, type of neurological impairment/type of clinician and previous experience of NIBS. Any information that is obtained from this study will remain confidential (unless required by law).
The questionnaire will involve a maximum of 6 choice sets presented to participants. A choice set will involve two specific NIBS programs presented to participants, with participants asked to choose the therapy they would prefer. An example of one is shown below. The therapy chosen by participants will take into consideration all of the characteristics described and will help to identify the attributes of NIBS that are valued the most.
Data storage and privacy issues:
All records containing personal information will remain confidential and no information which could lead to the identification of any individual will be released, unless required by law. Data will be stored in a form that is re-identifiable, but we will keep the coding for re-identification password secured and separately from the data file. All hard copy data files will be stored in a locked filing cabinet in the Centenary Building (C7-37) UniSA City-East campus. All electronic data will be stored in a password protected folder and backed up on the University drive. Only the listed investigators will have access to the data, and all data will be kept for a minimum of 5 years.
Although we plan to publish the results of this study, results will only be published at a group level and will be non-identifiable.
You are free to withdraw from this study at any stage if you wish to and do not have to explain your reasons for doing so. Any data collected prior to withdrawing from the study will be retained by the investigators.
If you would like to receive a summary of the research findings, please contact the Primary Supervisor (Dr Brenton Hordacre; contact details at end of this document).
What are the risks/benefits to you?
It is not expected that there will be any risks associated with participating in this study, given its questionnaire nature and the fact that NIBS will not be administered as part of this study. It is possible that some participants may become frustrated or distressed given the hypothetical nature of the therapy programs, and that these therapy programs cannot be guaranteed to be provided. Should this happen, all participants are able to withdraw at any time, without consequence.
Participation in this study may improve clinician translation of NIBS in neurologically impaired populations and aims to improve patient and clinician satisfaction of future applications. It is the opinions of participants in this study that will help to facilitate this.
This project has been approved by the University of South Australia's Human Research Ethics Committee. If you have any ethical concerns about the project or questions about your rights as a participant please contact the Executive Officer or this Committee, tel: +61 8 8302 3118; email: firstname.lastname@example.org.
If you have any concerns either before or following the experiment, or would like any further information, please feel free to contact one of the following researchers:
Clare Turnbull (Honours Student)
Dr Brenton Hordacre (Primary Supervisor)
Associate Professor Tasha Stanton (Co Supervisor)
Dr Rachel Milte (Co Supervisor)
The following information is regarding gaining your informed consent for participating in this questionnaire.
- I have read the Participant Information Sheet entitled “The Acceptability of Brain Stimulation: A discrete Choice Experiment”, and the nature and purpose of the research project has been explained to me. I understand and agree to take part
- I understand that the brain stimulation therapy programs presented to me are hypothetical and that my involvement may have no direct benefit to me.
- I understand the purpose of the research project and my involvement in it; and that prior to participating in the study I may be asked to explain in my own words my understanding of my involvement.
- I understand that I may withdraw from the research project at any stage and that this will not affect my status now or in the future.
- I understand that while information gained during the study may be published, I will not be identified and my personal results will remain confidential. No information, which could lead to the identification of any individual, will be released, unless required by law.
- I understand that data will be retained for a minimum of 5 years and will be stored in a locked filing cabinet (hard copy) or password protected electronic spreadsheet at the City East Campus, University of South Australia
- I am aware that I should retain a copy of this Consent Form, when completed, and the attached Information Sheet (email the research team for a copy if you would like one).
- I have been given the opportunity to have a member of my family or a friend present while the project was explained to me
By participating in this questionnaire, you are agreeing to the terms of consent listed above.
On behalf of the School of Health Sciences, we would like to thank you for your participation in this study that seeks to obtain the views of patients surrounding the use of brain stimulation in neurorehabilitation.
Participation in this study will improve our understanding of what patients consider important when it comes to this type of treatment. This may help to improve clinician translation of brain stimulation and ensure greater patient satisfaction.