What happens in this study
If the exams, tests, and procedures show that your dog can take part in the study, and you choose to enroll them, then the following will happen as part of the study:
- A repeat MRI of your dog’s head
- Brain surgery to implant electrodes
- CT scan of your dog’s head after surgery to make sure the electrodes are in the right place
- A surgery at the same time to implant a radio device under the skin near the shoulder blades
- Recheck physical and neurological examinations and evaluation of device function every 2 months for up to 2 years
Pet owner responsibilities
If you allow your dog to participate in this study, you will be responsible for keeping all scheduled visits, learning to care for and maintain the implanted device, committing to recharging of the ‘radio’ and transmission of data into storage, and covering the following costs:
- Diagnostics, treatment, or increased costs of hospitalization for unrelated illness that may develop during the 2 year course of the study;
- Veterinary care costs relating to treatment and hospitalization of chronic breakthrough seizure episodes, during the 2 year course of the study, unless it is likely to be related directly to the implanted device (infection or migration);
- Costs of complications from the implanted device above $5,000; and,
- Costs associated with rechecking, maintenance, or explanting of the device after the study is completed at 2 years.
NOTE: At the completion of the study (24 months), the implanted device will be removed. If you think it is helping your dog’s seizures and you would like to keep the device, it will be donated to you for the life of the device. However, ongoing recheck examinations will not be considered part of the study. Neither will the device be supported technically by the research personnel or grant money following the completion of the study. If you decide to keep the device after study completion, and it stops working, you will be responsible for paying for it’s removal. Conversely, it may be left in place but non-functional. If you do not want to keep the implanted device at the end of the study (i.e. at 2 years), it will be surgically removed, and paid for by the study.
This study will cover the surgical procedure, post-operative care for a routine recovery of up to 5 days, associated laboratory data, MR/CT imaging associated with implant placement, CSF collection and analysis, all implanted devices, all routine medications including anesthetic drugs, routine antibiotics, anticonvulsants (in hospital), fluids, and routine supportive care, post-operative recheck exam, and regular maintenance recheck exams every 2 months for 2 years, and coverage of complications that are associated with the procedure up to a limitation of $5,000 (e.g., seizures and complications from seizures (such as brain swelling); infection around the implant).
You will be provided with an estimate of the costs that are likely to be incurred during the treatment of your dog. If there are any significant changes to this estimate that arise during treatment, these will be discussed with you prior to proceeding with medical care of your dog.