Objective: The objective of this proposal is to create a novel MRI-guided steerable needle with the potential to
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