ABSTRACT
BACKGROUND: Chronic motor cortex stimulation (MCS) has been used to treat medically refractory neuropathic pain over the past 20 years. We investigated this procedure using a prospective multicentre randomized blinded crossover trial. METHODS: Twelve subjects with three different neuropathic pain syndromes had placement of MCS systems after which they were randomized to receive low ("subtherapeutic") or high ("therapeutic") stimulation for 12 weeks, followed by a crossover to the other treatment group for 12 weeks. The primary outcome measure was the pain visual analogue scale (VAS). Secondary outcome measures included McGill Pain Questionnaire (MPQ), Beck Depression Inventory-II, medication log, work status, global impression of change, and SF-36 quality of life scale. RESULTS: The trial was halted early due to lack of efficacy. One subject withdrew early due to protocol violation and five subjects withdrew early due to transient adverse events. Six subjects with upper extremity pain completed the study. There was no significant change in VAS with low or high stimulation and no significant improvement in any of the outcome measures from low to high stimulation. SF-36 role physical and mental health scores were worse with high compared to low stimulation (p=0.024, p=0.005). CONCLUSIONS: We failed to show that MCS is an effective treatment for refractory upper extremity neuropathic pain and suggest that previous studies may have been skewed by placebo effects, or ours by nocebo. We suggest that a healthy degree of skepticism is warranted when considering this invasive therapy for upper extremity pain syndromes.
Subject(s)
Motor Cortex , Neuralgia/surgery , Neuralgia/therapy , Adult , Double-Blind Method , Female , Humans , Male , Middle Aged , Pain Measurement/methods , Prospective Studies , Quality of Life , Treatment OutcomeABSTRACT
Vulnerability is an important criterion to assess the ethical justification of the inclusion of participants in research trials. Currently, vulnerability is often understood as an attribute inherent to a participant by nature of a diagnosed condition. Accordingly, a common ethical concern relates to the participant's decisionmaking capacity and ability to provide free and informed consent. We propose an expanded view of vulnerability that moves beyond a focus on consent and the intrinsic attributes of participants. We offer specific suggestions for how relational aspects and the dynamic features of vulnerability could be more fully captured in current discussions and research practices.
Subject(s)
Deep Brain Stimulation/ethics , Ethics, Research , Informed Consent/ethics , Patient Selection/ethics , Clinical Trials as Topic , Decision Making/ethics , Humans , Mental Disorders/therapy , Risk AssessmentABSTRACT
BACKGROUND: The expansion of neuromodulation and its indications has resulted in hundreds of thousands of patients with implanted devices worldwide. Because all patients require programming, this growth has created a heavy burden on neuromodulation centers and patients. Remote point-of-care programming may provide patients with real-time access to neuromodulation expertise in their communities. OBJECTIVE: To test the feasibility of remotely programming a neuromodulation device using a remote-presence robot and to determine the ability of an expert programmer to telementor a nonexpert in programming the device. METHODS: A remote-presence robot (RP-7) was used for remote programming. Twenty patients were randomly assigned to either conventional programming or a robotic session. The expert remotely mentored 10 nurses with no previous experience to program the devices of patients assigned to the remote-presence sessions. Accuracy of programming, adverse events, and satisfaction scores for all participants were assessed. RESULTS: There was no difference in the accuracy or clinical outcomes of programming between the standard and remote-presence sessions. No adverse events occurred in any session. The patients, nurses, and the expert programmer expressed high satisfaction scores with the remote-presence sessions. CONCLUSION: This study establishes the proof-of-principle that remote programming of neuromodulation devices using telepresence and expert telementoring of an individual with no previous experience to accurately program a device is feasible. We envision a time in the future when patients with implanted devices will have real-time access to neuromodulation expertise from the comfort of their own home.
Subject(s)
Neurosurgery/organization & administration , Neurosurgical Procedures/methods , Point-of-Care Systems/organization & administration , Robotics/organization & administration , Adult , Aged , Communication , Computer Graphics , Data Interpretation, Statistical , Feasibility Studies , Female , Humans , Male , Middle Aged , Neuronavigation , Nurses , Patient Satisfaction , Patients , Reproducibility of Results , Robotics/methods , Telemedicine/methodsABSTRACT
We describe the unusual clinical course of a patient with cranial dystonia (i.e., Meige syndrome) and additional upper limb involvement, who developed sustained relief of motor symptoms following cessation of a prolonged course of bilateral pallidal deep brain stimulation (DBS). Early response to therapy proved titratable and reversible; however, the patient gained independence from DBS in the fifth postoperative year and has since been more than a year without treatment or exacerbation of motor symptoms. Among the potential explanations for these neurological benefits lies the intriguing possibility that DBS therapy may have the capacity to induce plastic change that lessens or obviates the need for further treatment in susceptible patients.
