Brief Review of Subthalamic Nucleus Deep Brain Stimulation with a Multiple Independent Constant Current-Device in Parkinson's: Multicentre, Double-blind, Randomised Controlled Trial— Vitek 2020
This is a brief audio review. In the article Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicenter, double-blind, randomized, sham-controlled study. published, 2020 by Vitek and Colleagues, The outcomes and key points are as noted: This was a Phase I safety trial for a therapeutic device. Results supported the use of subthalamic nucleus deep brain stimulation for the treatment of Parkinson's disease. There were 26 serious adverse events in the trial, 18 patients in the treatment group and 8 in the control. Mean difference in from post implantation baseline to 3 months post randomization in increased ON time and no problematic dyskinesia between active and control groups was 3.03 h, p<0.0001. This was a Phase 3, Randomized controlled trial, Double blinded with 160 patients who were Patients ages 22 through 75 years old, with idiopathic Parkinson's disease, and 5 years of abnormal movement symptoms, and stable use of antiparkinsonian medication use for past 1 month, who were selected for research study interim analysis.
Vitek JL, Jain R, Chen L, Tröster AI, Schrock LE, House PA, Giroux ML, Hebb AO, Farris SM, Whiting DM, Leichliter TA, Ostrem JL, San Luciano M, Galifianakis N, Verhagen Metman L, Sani S, Karl JA, Siddiqui MS, Tatter SB, Ul Haq I, Machado AG, Gostkowski M, Tagliati M, Mamelak AN, Okun MS, Foote KD, Moguel-Cobos G, Ponce FA, Pahwa R, Nazzaro JM, Buetefisch CM, Gross RE, Luca CC, Jagid JR, Revuelta GJ, Takacs I, Pourfar MH, Mogilner AY, Duker AP, Mandybur GT, Rosenow JM, Cooper SE, Park MC, Khandhar SM, Sedrak M, Phibbs FT, Pilitsis JG, Uitti RJ, Starr PA. 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. Lancet Neurol. 2020 Jun;19(6):491-501. doi: 10.1016/S1474-4422(20)30108-3. Epub 2020 May 26. Erratum in: Lancet Neurol. 2020 Sep;19(9):e8. PMID: 32470421.
