Objective: The objective of this proposal is to create a novel MRI-guided steerable needle with the potential to cure epilepsy. Significance: This work is motivated by the prevalence of epilepsy where 1 in 150 people have the disorder (3.4 Million in the US alone), with 30% unresponsive to drug therapy, and 1% of all patients suffering sudden unexplained death each year (i.e. an estimated 500,000 people worldwide ? each year!) [1-5]. Amazingly, a proven intervention (surgical removal of the hippocampus) already exists that can cure approximately half of the total epilepsy patient population, yet it is rarely performed due to the invasiveness and perceived morbidity of the procedure [4,6-7]. Our objective in this proposal is to create a novel MRI-guided steerable needle that performs the same function as surgery, but does so through a simple needle insertion. Innovation: Our novel steerable needle will thermally ablate the hippocampus, which is the origin of seizures for 70% of all epilepsy patients. This approach is clinically innovative because it replaces open surgery with percutaneous thermal ablation. Technical innovation comes from (1) a novel helical superelastic steerable needle with anatomy-specific shaping, and (2) a novel 3D printed pneumatic robot that is intrinsically safe and enables real-time MRI guidance and thermometry, with directional laser ablation. We also propose an innovative new pathway for the needle into the brain, via needle insertion into the patient's cheek and passage through a small natural opening in the skull base called the foramen ovale. This pathway is currently used safely for recording electrodes to diagnose epilepsy, but it has never before been used for therapy delivery. Approach: We propose to create our MRI-guided steerable needle system through three Specific Aims.
Aim 1 involves designing our MRI-compatible robotic actuation system and the steerable needle itself.
Aim 2 focuses on MR imaging protocols for needle localization and MR-thermometry.
Aim 3 focuses on validation experiments, including experiments in phantoms, ex vivo tissues, and cadavers to evaluate needle tip placement accuracy, MR guidance and thermometry, and overall system functionality.
These Aims will be carried out by a multidisciplinary team of investigators combining expertise in epilepsy surgery (Neimat, Naftel, and Englot), mechanical design and control of MRI-compatible robotic systems (Barth), design and control of steerable needles (Webster), and MR imaging and thermometry (Grissom). The endpoint of this R01 project will be the demonstration of accurate spatial deployment, accurate ablator aiming, and accurate thermal monitoring to ablate a surgeon-prescribed volume of tissue. This will pave the way for clinical translation of this technology after the conclusion of this R01 in collaboration with industry partners (see attached support letters), bringing a potentially curative treatment for epilepsy to many more patients.
IMPACT Epilepsy affects 1 in 100 people with most patients opting not to undergo potentially curative surgical intervention because of the invasiveness of open brain surgery. Making matters worse, 1% of all epilepsy patients (500,000 worldwide ? each year!) will die suddenly for unexplained reasons, and even for those who live, 30% will face continual seizures because all available drugs will fail for them. This project focuses on providing a minimally invasive way to achieve the benefits of surgery without opening the skull, through use of a steerable needle delivered through the patient's cheek, with thermal therapy delivered to the brain and monitored in real time using MR imaging.
