Dual channel deep brain stimulation system (Kinetra) for Parkinson's disease and essential tremor: a prospective multicentre open label clinical study

Abstract

Objectives: To evaluate the safety and efficacy of a new dual channel stimulator (Kinetra) in patients with severe Parkinson's disease (PD) or essential tremor (ET). Methods: 111 patients with PD and 18 with ET were studied. Leads were implanted into the subthalamic nucleus (STN) or internal globus pallidus of patients with the akinetic/rigid type of PD. Leads were implanted into the ventral intermediate nucleus (VIM) of the thalamus or the STN in patients with the tremor dominant type of PD and in those with ET. Technical data on the device and adverse events occurring during the study were documented. Patients were assessed with established and validated clinical scales before surgery and at three and six months' follow up. Results: No device failure or unexpected adverse events occurred during the study. The dual channel stimulator used in stimulation of the STN, internal globus pallidus, and VIM in PD and ET was as safe and effective as the single channel stimulators in use. Mortality, morbidity, and infections were documented in the 129 treated patients. The parameter settings were similar to those usually programmed with single channel stimulators. Time spent in the operating room to implant the Kinetra system was systematically documented. In the PD group, improvement in the unified Parkinson's disease rating scale motor score, decrease in medication OFF periods, and reduced levodopa induced dyskinesia by bilateral STN stimulation were similar to those previously reported with bilaterally applied single channel stimulators. In the ET group upper and lower limb tremor scores were reduced by VIM stimulation. Activities of daily living improved in both disease groups. Conclusion: The Kinetra facilitated bilateral deep brain stimulation implantation surgery and is easy to use. It offers more advantages for the patient than the single channel stimulators; consequently, this new device may be recommended to treat patients with severe PD and ET.

Parkinson's disease subtypes: lost in translation?

“…Navan et al 33 studied the effects of pergolide and pramipexole on tremor in tremor dominant PD and found benefits over placebo in only 10 patients recruited. Vesper et al 34 studied the effects of deep brain stimulation on parkinsonian symptoms within groups of tremor dominant and akinetic–rigid PD. This was not a direct comparison, rather two separate analyses; they had used the subtypes to choose the electrode location (Vim thalamus in tremor dominant PD and subthalamic nucleus in akinetic–rigid PD) with very different therapeutic goals (thalamic stimulation to control tremor and subthalamic nucleus stimulation to improve all cardinal features of PD).…”

Is a Patient Controller for Parkinson’s Disease Patients with Subthalamic Nucleus Deep Brain Stimulation Reasonable?

“…The Itrel II was followed by a new generation of IPGs, with the dual-channel IPG Kinetra (Model 7428; Medtronic) becoming the preferred IPG for bilateral stimulation [8] . More recently, the Activa PC (Model 37601) and Activa RC (Model 37612) have been introduced as further dual-channel IPGs.…”

Battery Longevity Comparison of Two Commonly Available Dual Channel Implantable Pulse Generators Used for Subthalamic Nucleus Stimulation in Parkinson’s Disease

“…This acts as both the waveform generator and power source and sends a continuous electrical signal to the brain at a set amplitude, pulse width, and frequency. Although the early implantable DBS systems were single channel devices requiring insertion of 2 separate IPGs for bilateral symptom control, technological advancements have led to the creation of dual channel systems requiring insertion of only one IPG to target bilateral target nuclei [10]. Improvements in DBS battery technology, based largely on similar developments in the cardiac pacing industry, led Medtronic (Minneapolis, MN, USA) to introduce the first dual channel IPG in 1998.…”