Summary
Consistent with experience from more established DBS indications, our findings and other recent reports suggest that there may be specific sites within the ANT that are associated with superior clinical outcomes. It will be important to continue to evaluate these relationships and the evolution of other clinical practices (eg, programming) to further optimize this therapy.
Original Article
Analysis of Deep Brain Stimulation Lead Targeting in the Stimulation of Anterior Nucleus of the Thalamus for Epilepsy Clinical Trial
Neurosurgery
Gross, Robert E MD, PhD; Fisher, Robert S MD, PhD; Sperling, Michael R MD; Giftakis, Jonathon E PhD; Stypulkowski, Paul H PhD, on behalf of the SANTÉ Study Group
Abstract
Background
Deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) is an effective therapy for patients with drug-resistant focal epilepsy. Best practices for surgical targeting of the ANT can be refined as new information becomes available regarding effective stimulation sites.
Objective
To conduct a retrospective analysis of the relationship between outcomes (seizure reduction during year 1) and DBS lead locations in subjects from the SANTÉ pivotal trial (Stimulation of ANT for Epilepsy) based upon recent clinical findings.
Methods
Postoperative images from SANTÉ subjects (n = 101) were evaluated with respect to lead trajectory relative to defined anatomic landmarks. A qualitative scoring system was used to rate each lead placement for proximity to an identified target region above the junction of the mammillothalamic tract with the ANT. Each subject was assigned a bilateral lead placement score, and these scores were then compared to clinical outcomes.
Results
Approximately 70% of subjects had “good” bilateral lead placements based upon location with respect to the defined target. These subjects had a much higher probability of being a clinical responder (>50% seizure reduction) than those with scores reflecting suboptimal lead placements (43.5% vs 21.9%, P < .05).
Conclusion
Consistent with experience from more established DBS indications, our findings and other recent reports suggest that there may be specific sites within the ANT that are associated with superior clinical outcomes. It will be important to continue to evaluate these relationships and the evolution of other clinical practices (eg, programming) to further optimize this therapy.
Disclosures
Dr Gross serves as a consultant to Medtronic, which manufactures the devices used in this project. Dr Gross receives compensation for these services. Unrelated to this work, Dr Gross also received consulting fees from Neuropace, Abbott, Boston Scientific, Sanbio, Zimmer Biomet, Voyager Therapeutics and MRI Interventions and has stock options in Nia Therapeutics. The terms of these arrangements have been reviewed and approved by Emory University in accordance with its conflict of interest policies. Dr Fisher serves as a consultant to Medtronic. Unrelated to the subject of this paper, Dr Fisher owns stock or options in Avails Medical, Cerebral Therapeutics, Eysz, Irody, Smart Monitor and Zeto. Dr Sperling has received research support from Medtronic, SK Life Science, Cavion, Xenon, Takeda, Eisai, Neurelis, Engage Therapeutics, Pfizer, and UCB Pharma; has consulted for Medtronic (fee to institution); CME speaker: WebMD, Medscape, Eisai, Neurology Live and International Medical Press. Dr Giftakis is a clinical employee of Medtronic, the sponsor of the SANTÉ study, and holds stock options. Dr Stypulkowski is a retired employee of Medtronic. He currently serves as a consultant to Medtronic and holds stock options.
