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  • Bilateral Fornix Deep Brain Stimulation for Alzheimer’s Disease: Surgical Safety in the ADvance Trial

    Final Number:

    Francisco A. Ponce MD; Wael Asaad MD, PhD; Kelly D. Foote MD; William S. Anderson MD, PhD; Rees Cosgrove MD, FRCSC; Gordon H. Baltuch MD, PhD; Kara D. Beasley DO, MBe; Donald E Reymers; Esther S Oh; Steven D. Targum; Gwenn Smith; Constantine G. lyketsos; Andres M. Lozano MD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2015 Annual Meeting

    Introduction: This report describes the stereotactic technique, hospitalization, and 90-day perioperative safety in patients who underwent bilateral deep brain stimulation (DBS) of the fornix for the treatment of mild probable Alzheimer’s disease.

    Methods: The ADvance Trial is a multicenter, 12-month, double-blind, randomized, controlled, feasibility study being conducted to evaluate the safety, efficacy, and tolerability of DBS of the fornix in patients with mild probable Alzheimer’s disease. Intraoperative and perioperative data were collected prospectively. All patients underwent postoperative magnetic resonance imaging (MRI). Stereotactic analyses were performed in a blinded fashion by a single surgeon. Adverse events (AEs) were reported to an independent clinical events committee and adjudicated to determine relationship between the AE and the study procedure.

    Results: Between June 1, 2012 and April 30, 2014, 42 patients with mild probable Alzheimer’s disease were treated with bilateral fornix DBS (mean age 68.2 ± 7.8 [range 48.0 – 79.7], 19 male and 23 female). The mean planned target coordinates were x = 5.2 ± 1.0 mm (range 3.0 – 7.9), y = 9.6 ± 0.9 mm (range 8.0 – 11.6), z = -7.5 ± 1.2 mm (range -5.4 – -10.0), and the mean postoperative stereotactic radial error on MRI was 1.5 ± 1.0 mm (range 0.2 – 4.0). Mean length of hospitalization was 1.4 ± 0.8 days. Twenty-six (61.9%) patients experienced 64 adverse events related to the study procedure, of which 7 were serious adverse events experienced by 5 patients (11.9%). Four (9.5%) patients required return to surgery: 2 for explantation due to infection, 1 for lead repositioning, and 1 for chronic subdural hematoma. No patients experienced neurological deficits as a result of the study and no mortalities were reported.

    Conclusions: Accurate targeting of DBS to the fornix without direct injury to it is feasible across surgeons and centers. At 90 days after surgery, bilateral fornix DBS was well tolerated by patients with mild probable Alzheimer’s disease.

    Patient Care: This is a randomized trial evaluating the the possible use of DBS-f for Alzheimer's disease

    Learning Objectives: By the conclusion of this session, participants should be able to: 1) Describe the surgical technique used for DBS-f 2) Discuss patient selection criteria for the ADvance Trial 3) Comment on safety of DBS-f


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