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.
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.RÉSUMÉ: Stimulation du cortex moteur pour traiter la douleur neuropathique: une étude randomisée avec permutation. Contexte: La stimulation chronique du cortex moteur (SCM) a été utilisée pour traiter la douleur neuropathique réfractaire au traitement médical au cours des 20 dernières années. Nous avons étudié cette technique au moyen d'un essai prospectif multicentrique randomisé à double insu avec permutation. Méthode: Un système de SCM a été mis en place chez douze sujets atteints de trois syndromes différents de douleur neuropathique. Ils ont été assignés au hasard au groupe recevant une stimulation faible (« sous-thérapeutique ») ou élevée (« thérapeutique ») pendant 12 semaines avec permutation des groupes et traitement pendant 12 semaines additionnelles. Le critère d'évaluation primaire était le résultat obtenu à l'échelle visuelle analogue (EVA). Les critères d'évaluation secondaires comprenaient le questionnaire McGill sur la douleur, l'Inventaire de dépression de Beck II, un journal de la médication, la situation d'emploi, l'impression globale de changement et l'échelle SF-36 de qualité de vie. Résultats: L'étude a été interrompue précocement en raison du manque d'efficacité. Un sujet a été exclu tôt pour cause de non-respect du protocole et 5 sujets se sont retirés peu de temps après le début du traitement en raison d'effets indésirables passagers. Six sujets présentant de la douleu...
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.
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.
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