Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.

Autor:	Vitek JL; Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA. Electronic address: vitek004@umn.edu., Jain R; Division of Neuromodulation, Boston Scientific, Valencia, CA, USA., Chen L; Division of Neuromodulation, Boston Scientific, Valencia, CA, USA., Tröster AI; Department of Clinical Neuropsychology, Barrow Neurological Institute, Phoenix, AZ, USA., Schrock LE; Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA., House PA; Neurosurgical Associates, Murray, UT, USA., Giroux ML; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA; Clinical Research Neurology, Eisai, Woodcliff Lake, NJ, USA., Hebb AO; Department of Neurological Surgery, Kaiser Permanente, Denver, CO, USA., Farris SM; Division of Neuromodulation, Boston Scientific, Valencia, CA, USA; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA., Whiting DM; Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA., Leichliter TA; Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA., Ostrem JL; Department of Neurology, University of California, San Francisco, San Francisco, CA, USA., San Luciano M; Department of Neurology, University of California, San Francisco, San Francisco, CA, USA., Galifianakis N; Department of Neurology, University of California, San Francisco, San Francisco, CA, USA., Verhagen Metman L; Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA., Sani S; Department of Neurological Surgery, Rush University Medical Center, Chicago, IL, USA., Karl JA; Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA., Siddiqui MS; Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA., Tatter SB; Department of Neurosurgery, Wake Forest School of Medicine, Winston-Salem, NC, USA., Ul Haq I; Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA., Machado AG; Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA., Gostkowski M; Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA., Tagliati M; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Mamelak AN; Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA., Okun MS; Department of Neurology, College of Medicine, University of Florida, Gainesville, FL, USA., Foote KD; Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA., Moguel-Cobos G; Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA., Ponce FA; Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA., Pahwa R; Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA., Nazzaro JM; Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA., Buetefisch CM; Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA., Gross RE; Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA., Luca CC; Department of Neurology, University of Miami School of Medicine, Miami, FL, USA., Jagid JR; Department of Neurosurgery, University of Miami School of Medicine, Miami, FL, USA., Revuelta GJ; Department of Neurology, Medical University of South Carolina, Charleston, SC, USA., Takacs I; Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, USA., Pourfar MH; Department of Neurology, New York University Medical Center, New York City, NY, USA., Mogilner AY; Department of Neurosurgery, New York University Medical Center, New York City, NY, USA., Duker AP; Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA., Mandybur GT; Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, OH, USA., Rosenow JM; Department of Neurosurgery, Northwestern University School of Medicine, Chicago, IL, USA., Cooper SE; Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA., Park MC; Department of Neurosurgery, University of Minnesota School of Medicine, Minneapolis, MN, USA., Khandhar SM; Department of Neurology, Kaiser Permanente Medical Center, Sacramento, CA, USA., Sedrak M; Department of Neurosurgery, Kaiser Permanente Medical Center, Redwood City, CA, USA., Phibbs FT; Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA., Pilitsis JG; Department of Neurosurgery, Albany Medical Center, Albany, NY, USA., Uitti RJ; Department of Neurology, Mayo Clinic, Jacksonville, FL, USA., Starr PA; Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA.
Jazyk:	angličtina
Zdroj:	The Lancet. Neurology [Lancet Neurol] 2020 Jun; Vol. 19 (6), pp. 491-501. Date of Electronic Publication: 2020 May 26.
DOI:	10.1016/S1474-4422(20)30108-3
Abstrakt:	Background: Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease. Methods: This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396. Findings: Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation. Interpretation: This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes. Funding: Boston Scientific. (Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu