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  • INTREPID: A Prospective, Double Blinded, Multicenter Randomized Controlled Trial Evaluating Deep Brain Stimulation with a New Multiple Source, Constant Current Rechargeable System in Parkinson’s Disea

    Final Number:
    692

    Authors:
    Jerrold L Vitek MD, PhD; Roshini Jain MS; Lilly Chen; INTREPID Clinical Study Group; Philip A. Starr MD, PhD

    Study Design:
    Clinical Trial

    Subject Category:

    Meeting: Congress of Neurological Surgeons 2018 Annual Meeting

    Introduction: Deep Brain Stimulation (DBS) is an effective treatment for the motor signs and fluctuations associated with Parkinson's disease (PD). Although DBS efficacy has been substantiated by several randomized controlled trials (RCT), the degree of improvement varies significantly. The INTREPID Trial assessed improvement in motor function and quality of life in PD patients following bilateral subthalamic nucleus (STN) DBS using a new device with multiple independent current sources that allowed for selective activation of individual contacts on the DBS lead thereby permitting a defined distribution of applied current.

    Methods: INTREPID is a multicenter, prospective, double blinded RCT sponsored by Boston Scientific. Subjects were implanted bilaterally in the STN with a multiple source constant current DBS System (Vercise System). Blinded subjects were randomized to either receive active vs. control settings for a 12 week period. All assessments were completed by a blinded assessor. Following the blinded period, subjects received their best therapeutic settings. Improvement in motor function and quality of life was evaluated using PD diary, UPDRS, PDQ- 39, and a battery of neuropsychological assessments. Adverse events were recorded.

    Results: The study successfully met the primary endpoint (p < 0.001) with a mean difference of 3.03 ± 4.2 hours from baseline to 12 weeks between the active and control groups in ON time (PD diary), with no increase in antiparkinsonian medications. The study also met several of the secondary endpoints. The incidence of infection was 2.7% and peri-operative intracranial hemorrhage was 1%.

    Conclusions: The results of the INTREPID Trial demonstrate that the use of a multiple source, constant-current DBS System is safe and effective in the treatment of Parkinson’s disease symptoms.

    Patient Care: This research study examines a new DBS device capable of multiple independent current sources allowing for selective activation of individual contacts on the DBS lead thereby permitting a defined distribution of applied current. The results of this RCT therefore indicate that this DBS device has the capability of providing DBS patients with safe and effective treatment for PD motor symptoms.

    Learning Objectives: By the conclusion of this session, participants will be informed of the results of the INTREPID randomized, controlled clinical trial with particular emphasis on results regarding improvement in motor function and quality of life in patients with advanced, levodopa-responsive Parkinson's disease (PD) following bilateral subthalamic nucleus Deep Brain Stimulation (DBS) using a new device with multiple current sources that provides for the selective activation of individual contacts on the DBS lead.

    References:

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