Stereotactic and functional neurosurgery
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Stereotact Funct Neurosurg · Jan 2021
Randomized Controlled TrialA Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease.
Asleep deep brain stimulation (DBS) for Parkinson's disease (PD) is being performed more frequently; however, motor outcomes and safety of asleep DBS have never been assessed in a prospective randomized trial. ⋯ Owing to its randomized design, our study supports the hypothesis that motor outcomes after asleep STN-DBS in PD may be noninferior to the standard awake procedure.
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Stereotact Funct Neurosurg · Jan 2000
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialTechnical data and complications of spinal cord stimulation: data from a randomized trial on critical limb ischemia.
This study was done to evaluate the effect of spinal cord stimulation (SCS) on critical limb ischemia and to report technical problems and complications. One hundred and twenty patients with critical limb ischemia were eligible for randomization between medical treatment and medical treatment plus SCS. Sixty received a spinal cord stimulator (Itrel II; Medtronic, Minneapolis, Minn., USA). ⋯ Lead displacement remains the major technical problem. The search for prognostic factors of limb salvage is important. One microcirculatory measurement (TcpO2) seems to have a prognostic value, which remains to be described more precisely.
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Stereotact Funct Neurosurg · Jan 1999
Randomized Controlled Trial Multicenter Study Clinical Trial Controlled Clinical TrialLong-term multicenter experience with vagus nerve stimulation for intractable partial seizures: results of the XE5 trial.
Intermittent stimulation of the left cervical vagus nerve trunk (VNS) with the NeuroCybernetic Prosthesis (NCP) is emerging as a novel adjunct in the management of medically refractory epilepsy. We review the safety and efficacy of VNS 1 year after completion of the E05 study, the largest controlled clinical trial of VNS to date. ⋯ The long-term multicenter safety, efficacy, feasibility and tolerability of VNS, as well as the durability of the NCP device have been confirmed. Unlike chronic therapy with antiepileptic medication, the efficacy of VNS is maintained during prolonged stimulation, and overall seizure control continues to improve with time.
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Stereotact Funct Neurosurg · Jan 1994
Randomized Controlled Trial Comparative Study Clinical TrialA prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: initial results.
Spinal cord stimulation (SCS) has been reported to be effective treatment for the failed back surgery syndrome in a number of retrospective case series. Its retrospectively reported results compare favorably with those of neurosurgical treatment alternatives, such as reoperation and ablative procedures. There has been no direct prospective comparison, however, between SCS and other techniques for pain management. ⋯ The primary outcome measure is the frequency of crossover to the alternative procedure, if the results of the first have been unsatisfactory after 6 months. Results for the first 27 patients reaching the 6-month crossover point show a statistically significant (p = 0.018) advantage for SCS over reoperation. This is one of many potentially important outcome measures, which are to be followed long-term as a larger overall study population accrues.