Conflicts of Interest: Jian-guo Zhang is a consultant for PINS Medical. The other authors reported no conflicts of interest. PINS Medical contributed to the collection, monitoring, and management of the data. However, the manuscript was solely written by the authors. The authors take full responsibility for the integrity of the data and the accuracy of the data analysis. All authors contributed to the recruitment of patients or performance of surgery and were members of the writing committee.
Editor’s Choice: Prospective Nonrandomized Trial
Subthalamic Deep Brain Stimulation With a New Device in Parkinson's Disease: An Open-Label Trial
Version of Record online: 28 MAR 2013
© 2013 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 16, Issue 3, pages 212–218, May/June 2013
How to Cite
Subthalamic Deep Brain Stimulation With a New Device in Parkinson's Disease: An Open-Label Trial.Neuromodulation 2013; e-pub ahead of print. DOI: 10.1111/ner.12050, , , , , , , , , , , ,
For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/bw/submit.asp?ref=1094-7159&site=1
Huan-guang Liu and Yu Ma contributed equally to this work.
- Issue online: 4 JUN 2013
- Version of Record online: 28 MAR 2013
- Manuscript Accepted: 7 FEB 2013
- Manuscript Revised: 14 JAN 2013
- Manuscript Received: 1 AUG 2012
- National Key Technology Research and Development Program of China. Grant Number: 2011BAI12B07
- Research Fund of Capital Medical Development. Grant Number: 2009-1039
- deep brain stimulation;
- Parkinson's disease;
- PINS device;
- subthalamic nucleus;
We aimed to evaluate the safety and efficacy of subthalamic nucleus deep brain stimulation (STN-DBS) with a new stimulator (Beijing PINS Medical Co., Ltd, PNS 1101) in Parkinson's disease (PD).
Materials and Methods
Forty patients received a PINS device implantation in the subthalamic nucleus. The effects of stimulation on motor score, activities of daily living, good-quality on-time, and the levodopa-equivalent dose were analyzed for all 40 patients with PD treated with bilateral or unilateral STN-DBS. The scores were collected at baseline in two conditions (on/off medication) and at 3, 6, 9, 12, and 24 months of follow-up with stimulation in the absence or presence of medication. The patients were followed up for two years.
At 3, 6, 9, 12, and 24 months of follow-up, our results showed a significant increase from baseline in both activities of daily living and motor scores (p < 0.001) and good-quality on-time (p < 0.001); the daily levodopa-equivalent dose decreased compared with baseline (p < 0.01). No patient died during the study, and none of the adverse effects were classified as severe. All of the adverse events were resolved or improved by the end of the study.
STN-DBS with the PINS device significantly improved the symptoms of PD when compared with baseline in this trial. This new device may be recommended for the treatment of patients with advanced PD; however, a randomized, double-blinding trial will be required.