Deep brain stimulation: Preoperative issues Lang, Anthony E.; Houeto, Jean-Luc; Krack, Paul ...
Movement disorders,
June 2006, Letnik:
21, Številka:
S14
Journal Article, Conference Proceeding
Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, ...randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3–4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
Boston Scientific.
OBJECTIVE:To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localization-related ...epilepsy.
METHODS:This long-term follow-up is a continuation of a previously reported trial of 5- vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigatorsʼ discretion. Seizure frequency was determined using daily seizure diaries.
RESULTS:The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (≥50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p < 0.001).
CONCLUSION:Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population.
CLASSIFICATION OF EVIDENCE:This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.
Recent studies show that deep brain stimulation can be performed safely and accurately without microelectrode recording ortest stimulation but with the patient under general anesthesia. The procedure ...couples techniques for direct anatomical targeting on MRI with intraoperative imaging to verify stereotactic accuracy. However, few authors have examined the clinical outcomes of Parkinson's disease (PD) patients after this procedure. The purpose of this study was to evaluate PD outcomes following "asleep" deep brain stimulation in the globus pallidus internus (GPi).
The authors prospectively examined all consecutive patients with advanced PD who underwent bilateral GPi electrode placement while under general anesthesia. Intraoperative CT was used to assess lead placement accuracy. The primary outcome measure was the change in the off-medication Unified Parkinson's Disease Rating Scale motor score 6 months after surgery. Secondary outcomes included effects on the 39-Item Parkinson's Disease Questionnaire (PDQ-39) scores, on-medication motor scores, and levodopa equivalent daily dose. Lead locations, active contact sites, stimulation parameters, and adverse events were documented.
Thirty-five patients (24 males, 11 females) had a mean age of 61 years at lead implantation. The mean radial error off plan was 0.8 mm. Mean coordinates for the active contact were 21.4 mm lateral, 4.7 mm anterior, and 0.4 mm superior to the midcommissural point. The mean off-medication motor score improved from 48.4 at baseline to 28.9 (40.3% improvement) at 6 months (p < 0.001). The PDQ-39 scores improved (50.3 vs 42.0; p = 0.03), and the levodopa equivalent daily dose was reduced (1207 vs 1035 mg; p = 0.004). There were no significant adverse events.
Globus pallidus internus leads placed with the patient under general anesthesia by using direct anatomical targeting resulted in significantly improved outcomes as measured by the improvement in the off-medication motor score at 6 months after surgery.
Action (verb) fluency is a newly developed verbal fluency task that requires the examinee to rapidly generate as many verbs (i.e., "things that people do") as possible within 1 min. Existing ...literature indicates that action fluency may be more sensitive to frontal-basal ganglia loop pathophysiology than traditional noun fluency tasks (e.g., animal fluency), which is consistent with the hypothesized neural dissociation between noun and verb retrieval. In the current study, a series of analyses were undertaken to examine the psychometric properties of action fluency in a sample of 174 younger healthy participants. The first set of analyses describes the development of demographically adjusted normative data for action fluency. Next, a group of hypothesis-driven correlational analyses reveals significant associations between action fluency and putative tests of executive functions, verbal working memory, verbal fluency, and information processing speed, but not between action fluency and tests of learning or constructional praxis. The final set of analyses demonstrates the test-retest stability of the action fluency test and provides standards for determining statistically reliable changes in performance. In sum, this study enhances the potential clinical applicability of action fluency by providing demographically adjusted normative data and demonstrating evidence for its reliability and construct validity.
Deep brain stimulation of the subthalamic nucleus (STN DBS) is an increasingly common treatment for Parkinson's disease. Qualitative reviews have concluded that diminished verbal fluency is common ...after STN DBS, but that changes in global cognitive abilities, attention, executive functions, and memory are only inconsistently observed and, when present, often nominal or transient. We did a quantitative meta-analysis to improve understanding of the variability and clinical significance of cognitive dysfunction after STN DBS.
We searched MedLine, PsycLIT, and ISI Web of Science electronic databases for articles published between 1990 and 2006, and extracted information about number of patients, exclusion criteria, confirmation of target by microelectrode recording, verification of electrode placement via radiographic means, stimulation parameters, assessment time points, assessment measures, whether patients were on levodopa or dopaminomimetics, and summary statistics needed for computation of effect sizes. We used the random-effects meta-analytical model to assess continuous outcomes before and after STN DBS.
Of 40 neuropsychological studies identified, 28 cohort studies (including 612 patients) were eligible for inclusion in the meta-analysis. After adjusting for heterogeneity of variance in study effect sizes, the random effects meta-analysis revealed significant, albeit small, declines in executive functions and verbal learning and memory. Moderate declines were only reported in semantic (Cohen's
d 0·73) and phonemic verbal fluency (0·51). Changes in verbal fluency were not related to patient age, disease duration, stimulation parameters, or change in dopaminomimetic dose after surgery.
STN DBS, in selected patients, seems relatively safe from a cognitive standpoint. However, difficulty in identification of factors underlying changes in verbal fluency draws attention to the need for uniform and detailed reporting of patient selection, demographic, disease, treatment, surgical, stimulation, and clinical outcome parameters.
ABSTRACT
Introduction
Younger age of onset and mild cognitive impairment (MCI) are both independently associated with poorer quality of life (QOL) in Parkinson's disease (PD).
Objectives
The primary ...objective was to determine whether MCI differentially impacts QOL in young‐onset PD (YOPD) and typical‐onset PD (TOPD).
Methods
YOPD patients (n = 77) were diagnosed at age 50 or younger, TOPD (n = 77) were diagnosed after age 50, and the groups were matched for cognitive status, education, and disease duration. Patients' cognitive status was classified as MCI or cognitively normal (CN) based on MDS Level II criteria. QOL was assessed using the Parkinson's Disease Questionnaire (PDQ‐39). ANCOVAs were conducted for each PDQ‐39 subscale, with age of onset and cognitive status as between‐subjects factors and several covariates included.
Results
An interaction for the Cognition domain revealed that in TOPD, PD‐MCI patients reported poorer QOL than CN patients, whereas there was no effect of MCI on cognitive satisfaction in YOPD. There was a main effect of age on Emotional Well‐Being, as YOPD reported poorer QOL than TOPD in this domain. There were main effects of cognitive status, with PD‐MCI patients reporting worse QOL than CN patients in the domains of Social Support, Communication, ADLs, and Mobility.
Conclusions
The interaction revealed that PD‐MCI has a greater impact on degree of cognitive concerns (“cognitive QOL”) in TOPD versus YOPD. A more nuanced understanding of the effects of age of onset, MCI, and their interactions on QOL in PD will inform interventions aimed at improving quality of life in this population.
Symptom exaggeration or fabrication occurs in a sizeable minority of neuropsychological examinees, with greater prevalence in forensic contexts. Adequate assessment of response validity is essential ...in order to maximize confidence in the results of neurocognitive and personality measures and in the diagnoses and recommendations that are based on the results. Symptom validity assessment may include specific tests, indices, and observations. The manner in which symptom validity is assessed may vary depending on context but must include a thorough examination of cultural factors. Assessment of response validity, as a component of a medically necessary evaluation, is medically necessary. When determined by the neuropsychologist to be necessary for the assessment of response validity, administration of specific symptom validity tests are also medically necessary.
This paper highlights major developments over the past two to three decades in the neuropsychology of movement and its disorders. We focus on studies in healthy individuals and patients, which have ...identified cognitive contributions to movement control and animal work that has delineated the neural circuitry that makes these interactions possible. We cover advances in three major areas: (1) the neuroanatomical aspects of the "motor" system with an emphasis on multiple parallel circuits that include cortical, corticostriate, and corticocerebellar connections; (2) behavioral paradigms that have enabled an appreciation of the cognitive influences on the preparation and execution of movement; and (3) hemispheric differences (exemplified by limb praxis, motor sequencing, and motor learning). Finally, we discuss the clinical implications of this work, and make suggestions for future research in this area. (JINS, 2017, 23, 768-777).
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