Who is sponsoring the INTREPID study?
The INTREPID study is sponsored by Boston Scientific, a worldwide developer and manufacturer of medical devices. For more than 30 years, Boston Scientific has advanced the practice of less-invasive medicine by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. Neuromodulation is a major area of practice, expertise and advancement for the company. The Vercise™ system is now commercially available in Europe and Australia.
What is the goal of the study?
The study team is evaluating the safety and effectiveness of the Vercise™ DBS system as a therapy for reducing some of the symptoms associated with Parkinson's disease (PD) that are not adequately controlled with medication.
What sets Vercise™ apart from other marketed DBS devices?
- Multiple Independent Current Control (MICC) – 16 independent current sources designed for customizable stimulation
- 5-year rechargeable battery
- Smaller-size DBS IPG
- Wireless IPG charger, which can be worn over or under your clothes
- 8-contact DBS lead
How many people will participate in this study?
Up to 310 Parkinson's disease patients will participate in this study, which will be conducted at approximately 20 study sites, most of them major universities or teaching centers.
How long will the study last?
Your participation in this study is expected to last approximately 5.5 years, including screening, device implantation, post-surgical evaluation and follow-up.
Will I be responsible for any medical costs?
Prior authorization from your insurance company, Medicare or Medicaid will be obtained prior to your participation in the study, and they may cover all or certain portions of the surgical costs. Please contact your study coordinator for further guidance.
What if I want to participate, but travel to the study site is problematic?
You are encouraged to discuss any travel issues with your study coordinator. Boston Scientific may be willing to arrange and fund travel and/or lodging. Each situation will be evaluated individually.
How will my study physician determine if I am eligible to participate in the study?
You will be required to go through a few screening procedures to understand whether you are a good candidate for this study. The following activities will take place during the screening process:
- Signing the informed consent document
- Review of medical history and anti-PD medications
- Physical examination
- Neuropsychological evaluation
- Surgical evaluation
- Completion of questionnaires related to your disease state and health status
- Assessments of your PD symptoms (some tests will be conducted with your medications withheld overnight)
- Completion of a 3-day PD diary about your PD symptoms
- Magnetic Resonance Imaging (MRI) of the head
Once you satisfy all eligibility criteria, you will be scheduled to receive the DBS implant.
If it is determined that I am eligible to participate in the study, what can I expect?
- 1 to 3 separate procedures to implant the Vercise™ system, depending on your surgeon's preference
Additional details of the study design and follow-up visits can be found on clinicaltrials.gov and will be discussed with you by the study doctor if you are determined eligible for study participation and the DBS procedure.
May I withdraw from the study?
Your participation is voluntary. You may choose not to be in the study, and you may withdraw from the study at any time. There will be no penalty or loss of benefit to you if you decide not to be in the study. However, since this device/procedure/etc. is experimental, only patients enrolled in the study are able to receive it. If you decide not to participate in this study, the care you would normally receive as part of routine care will not change. You will be asked to have the Vercise™ system deactivated and to return all equipment (i.e., charger and remote control).