We would like to ask if you are willing to participate in scientific research conducted by the ENT departments of the MUMC+ in Maastricht (Netherlands) and Aalborg University Hospital (Denmark). The principal investigator is Dr. Michel Talebnasab (Aalborg), collaborating with Prof. Dr. Herman Kingma (MUMC+ and Aalborg). The study focuses on the treatment of patients with severe balance issues due to significant bilateral vestibular organ dysfunction or suspicion thereof.
Purpose of the Research
The purpose of this study is to test a treatment for patients with poorly or non-functioning bilateral vestibular organs, resulting in very poor balance. The new treatment involves wearing a belt with small vibrators that provide missing information to the brain via the waist, potentially improving balance. This vibration stimulation is also known as haptic stimulation. The belt is worn throughout the day when you are active.
Information about Participation
Before deciding whether to participate in the research, it is essential that you fully understand the research’s content and purpose. Therefore, we ask you to read this participant information carefully.
You will receive a phone call from the study manager or their colleague one to three weeks after receiving this letter. The phone call will include questions to determine if you are eligible and interested in participating in the study. Enclosed with this letter are some questionnaires that we can go through during the call if you are interested. During the call, we can help you accurately answer these questions. You will also receive oral information about the entire study and have the opportunity to ask any questions. If you do not wish to participate, you can indicate this during the call. If we cannot reach you after repeated attempts within three weeks, we will consider this a refusal. However, if you were unavailable for any reason and still wish to be called, you can always contact the undersigned.
If you express interest in participating during the call, you will be invited for a discussion preceded by filling out some additional surveys. During this first meeting, this participant information will be further discussed, and you can ask any questions about the research. You are welcome to bring a family member, friend, or acquaintance to the interview.
If you decide to participate in the study, we will ask you to sign a consent form. This can be done during the meeting or later, as you are entitled to a reflection period before signing the form. Participation is voluntary, and you can withdraw your consent at any time without providing a reason, which will not affect your further treatment.
If, after the initial assessments, you do not meet the criteria for the study or do not wish to participate, you will continue with the usual treatment you would have received otherwise. This includes, if you haven’t already, physiotherapeutic vestibular rehabilitation, and the option to try the haptic stimulation treatment, the balance belt, without participating in the study.
Study Timeline
First Visit:
- Balance assessments
- Consultation with a doctor
- Consent form and enrollment in the study
- Consultation with balance assessments and questionnaires
- Instruction in the use of the actometer and issuance of the actometer
First Home Period:
- Wearing the balance belt with actometer but without vibration for one month
Second Visit:
- Vestibular assessments
- Consultation with balance assessments and questionnaires
- Instruction in the use of the balance belt and issuance of the belt
Second Home Period:
- First type of haptic stimulation with the balance belt for one month
Third Visit:
- Consultation with balance assessments and questionnaires
- Recalibration of the belt
Third Home Period:
- Second type of haptic stimulation for one month
Fourth Visit:
- Consultation with balance assessments and questionnaires
Fourth Home Period:
- Wearing the balance belt with actometer but without vibration for one month
Fifth Visit:
- Returning the balance belt with actometer
- Consultation with balance assessments and questionnaires
- Final consultation with a doctor, including planning of further treatment. Continuing the treatment with the balance belt if desired.
Benefits of the Research
Haptic stimulation is a new alternative to intensive physiotherapeutic vestibular rehabilitation, which has limited effect for patients with severely reduced bilateral vestibular function. The new treatment does not aim to restore vestibular organ function. Instead, the balance belt provides information via vibrations to your body and brain about your movements. You do not need to pay attention to or respond to the vibrations; your brain will automatically start using these vibrations for better balance, unconsciously. Those who benefit from the treatment will experience improved balance, enhancing mobility, daily life, and quality of life. If the treatment proves effective for certain patient groups, it will contribute to the long-term development of the technique and treatment, benefiting patients worldwide.
Side Effects, Risks, Complications, and Disadvantages
The research does not involve risks, complications, or serious side effects. The disadvantage of haptic stimulation is that some may hear it as a soft, low-frequency sound. There are no side effects associated with haptic stimulation. The balance tests may occasionally cause mild dizziness, nausea, general fatigue, or headaches, which in very rare cases can last for a few days. It is important to note that all tests are internationally recognized and routinely performed in our clinics.
There may be unknown risks associated with the experiment. Therefore, we ask you to inform us if you experience health problems during the study. If we discover side effects not previously reported, you will be informed immediately and must decide whether to continue with the trial.
Alternative Treatment Options
- Physiotherapeutic vestibular rehabilitation
Exclusion and Suspension of the Study
The study may need to be stopped if you do not attend consultations or other appointments within the study or if your health condition does not justify further participation. The study can be discontinued if circumstances arise that do not justify continuation based on a concrete assessment. This applies especially if severe or long-lasting side effects, risks, complications, or disadvantages occur.
Access to Patient Records and Data Processing
By giving written consent, you grant the principal investigators, their sponsor (the ENT, Head-Neck Surgery, and Audiology department of Aalborg University Hospital and Maastricht University Medical Center), and their representatives direct access to relevant health information in the medical records to conduct, monitor, and control the experiment. This includes information about medical conditions that occurred earlier or during the study and may affect the results.
Personal data will be processed as part of the project. This processing complies with the requirements of the Dutch and Danish Data Protection Acts and the General Data Protection Regulation (GDPR).
Financial Conditions
The trial is initiated at the Balance and Dizziness Center, ENT, Head-Neck Surgery, and Audiology department, Aalborg University Hospital, and the balance department within the ENT department of Maastricht University Medical Center. All costs are covered by the participating departments. The belts used in the study are loaned to these ENT departments.
The principal investigators have no financial or other conflicts of interest, including ties to companies or foundations with a stake in the project. There is no financial compensation for participation as a participant.
Access to Research Results
The research results will be published as scientific studies in international journals and presented at both national and international conferences. We expect the trials to be completed in 2025 and the studies to be published in 2025-2026.
We hope this information has given you sufficient insight into what it means to participate in the study and that you are adequately informed to decide on your possible participation. If you would like to know more about the study, you can contact the undersigned during normal working hours.
Sincerely,
Prof. Dr. Herman Kingma
ENT Departement MUMC+
0646149631 (Prof. Dr. Kingma)
