Bilateral deep brain stimulation of the fornix for Alzheimer's disease: surgical safety in the ADvance trial

• DOI: 10.3171/2015.6.jns15716
• Publication Date: 2015-12-18T15:43:20Z
• Authors: Francisco A. Ponce; Wael F. Asaad; Kelly D. Foote; William S. Anderson; G. Rees Cosgrove; Gordon H. Baltuch; Kara Beasley; Donald E. Reymers; Esther S. Oh; Steven D. Targum; Gwenn S. Smith; Constantine G. Ly...; Andres M. Lozano
• Keywords: Fornix

OBJECT This report describes the stereotactic technique, hospitalization, and 90-day perioperative safety of bilateral deep brain stimulation (DBS) fornix in patients who underwent DBS for treatment mild, probable Alzheimer's disease (AD). METHODS The ADvance Trial is a multicenter, 12-month, double-blind, randomized, controlled feasibility study being conducted to evaluate safety, efficacy, tolerability with AD. Intraoperative data were collected prospectively. All postoperative MRI. Stereotactic analyses performed blinded fashion by single surgeon. Adverse events (AEs) reported an independent clinical committee adjudicated determine relationship between AE procedure. RESULTS Between June 6, 2012, April 28, 2014, total 42 AD treated (mean age 68.2 ± 7.8 years; range 48.0–79.7 23 men 19 women). mean planned target coordinates x = 5.2 1.0 mm (range 3.0–7.9 mm), y 9.6 0.9 8.0–11.6 z −7.5 1.2 −5.4 −10.0 radial error on MRI was 1.5 0.2–4.0 mm). length hospitalization 1.4 0.8 days. Twenty-six (61.9%) experienced 64 AEs related procedure, which 7 serious 5 (11.9%). Four (9.5%) required return surgery: 2 explantation due infection, 1 patient lead repositioning, chronic subdural hematoma. No neurological deficits as result study, no deaths reported. CONCLUSIONS Accurate targeting without direct injury it feasible across surgeons centers. At 90 days after surgery, well tolerated Clinical trial registration no.: NCT01608061 ( clinicaltrials.gov )