Category: Parkinson’s Disease: Clinical Trials
Objective: The long-term effectiveness of a Deep Brain Stimulation (DBS) device capable of Multiple Independent Current Control (MICC) is assessed in a prospective, sham-controlled, double-blind randomized controlled trial (RCT) where participants are followed for up to 5-years for the treatment of motor symptoms of Parkinson’s disease (PD).
Background: Subthalamic Nucleus (STN) DBS is an established therapeutic option for managing the motor symptoms of PD, and here we report long-term open-label outcomes (up to 4-years) of a double-blind RCT with sham control using an MICC-based DBS device.
Method: INTREPID (Clinicaltrials.gov: NCT01839396) is a multi-center, prospective, double-blinded RCT. Subjects were implanted bilaterally in the STN with a multiple-source, constant-current DBS system (Vercise, Boston Scientific). Subjects were randomized to either receive active versus control settings for 12 weeks. Upon completion of the 12-week blinded period, subjects received their best therapeutic settings in the open-label phase. During long-term follow-up, motor improvement and quality of life was evaluated using UPRDS, PDQ39, and Schwann and England. Adverse events were also collected.
Results: Analysis of the pre-specified primary endpoint demonstrated a mean difference of 3.03 ± 4.52 hours (p<0.001) between active and control groups in ON time without troublesome dyskinesia, with no increase in antiparkinsonian medication, from post-implant baseline to 12-weeks post-randomization. A 49% (p<0.001) improvement in UPDRS III scores (meds off) at 1-year was previously reported and sustained up to 3-year follow-up (46%, p<0.001). Eighty-nine percent of patients at 3-year follow-up reported high satisfaction with their treatment. At 4-year follow-up, improvement in motor function (41%, UPDRS III scores) and quality of life was sustained.
Conclusion: Long-term follow-up from the INTREPID RCT demonstrates that the use of a multiple-source, constant-current DBS system is safe and effective with sustained improvement in motor function and quality of life up to 4-years post-implant.
References: NA
To cite this abstract in AMA style:
J. Vitek, R. Jain, L. Chen, A. Tröster, L. Schrock, P. House, M. Giroux, A. Hebb, S. Farris, D. Whiting, T. Lechleiter, J. Ostrem, M. San Luciano, N. Galifianakis, L. Verhagen Metman, S. Sani, J. Karl, M. Siddiqui, S. Tatter, I. Ul Haq, A. Machado, M. Gostkowski, M. Tagliati, A. Mamelak, M. Okun, K. Foote, G. Moguel-Cobos, F. Ponce, R. Pahwa, J. Nazarro, C. Buetefisch, R. Gross, C. Luca, J. Jagid, G. Revuelta, I. Takacs, M. Pourfar, A. Mogilner, A. Duker, G. Mandybur, J. Rosenow, S. Cooper, M. Park, S. Khandhar, M. Sedrak, F. Phibbs, J. Pilitsis, R. Uitti, P. Starr. Long-Term Evaluation of Deep Brain Stimulation for Treatment of Parkinson’s Disease Using a Multiple-Source, Constant-Current Rechargeable System: 4-year Follow-Up of a Prospective, Double-Blind RCT [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/long-term-evaluation-of-deep-brain-stimulation-for-treatment-of-parkinsons-disease-using-a-multiple-source-constant-current-rechargeable-system-4-year-follow-up-of-a-prospective-double-blind-rct/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-evaluation-of-deep-brain-stimulation-for-treatment-of-parkinsons-disease-using-a-multiple-source-constant-current-rechargeable-system-4-year-follow-up-of-a-prospective-double-blind-rct/