Psychosocial characteristics of candidates for implantable pain devices: validation of an assessment model.

Aim: To provide a detailed profile of Veteran and community patients with chronic pain who completed preprocedural psychological evaluations for implantable pain devices. Patients & methods: A total of 157 candidates completed a preimplantable pain device evaluation between June 2018 and October 2019 with a pain psychologist that included a structured interview, elicitation of patient-centered goals for the implantable device, and psychometric testing. Results: Candidates demonstrated moderate to high rates of sleep impairment (73%), depressive symptoms (62%), anxiety symptoms (61%), pain catastrophizing (37%), cognitive impairment screen (30%) and somatic symptoms (24%). Conclusion: Candidates for implantable pain devices report high rates of mood, sleep and cognitive impairment, reinforcing the value of preprocedural psychological evaluations.

Fixed-Life or Rechargeable Battery for Deep Brain Stimulation: A Prospective Long-Term Study of Patient's Preferences.

INTRODUCTION: Deep brain stimulation (DBS) is an established treatment for movement disorders. We have previously shown that in our practice, the majority of adult patients prefer fixed-life implantable pulse generators (IPGs), although rechargeable batteries are increasingly used. The aim of this study was to evaluate patients' long-term satisfaction with their choice of battery and factors that influence their decision. METHODS: Thirty patients with DBS were given a questionnaire to assess long-term satisfaction and experience with the type of battery they had chosen. RESULTS: Twenty-six patients completed the survey. The mean age was 67.7 ± 7.3 years, and mean follow-up was 18.0 ± 7.2 months. The indications for DBS were Parkinson's disease (76.9%), tremor (11.5%) and dystonia (11.5%). Eleven patients (42.5%) had chosen the rechargeable battery. All patients were still happy with their choices and would not change the type of battery if they had the chance to do so. However, in patients who chose the fixed-life battery, concern about the size of battery rose from 6.7% pre-operatively to 60% on long-term post-operative follow-up. In patients who chose the rechargeable battery, concern about the need to recharge the battery did not change, remaining low postoperatively. Interestingly, even though the main reason cited for choosing the fixed-life battery was the convenience and concern about forgetting to recharge the battery, patients who had chosen a rechargeable IPG did not experience this problem. CONCLUSION: Patients and caregivers should be involved in the choice of battery, as each type of IPG has its own advantages and disadvantages. Long-term evaluation of patient's experience and satisfaction with battery of choice revealed that size of the IPG, need for further replacement surgeries and need for recharging remain matters of major concern. Although preoperatively often underestimated, the size of the battery seems to be an important factor in long-term satisfaction.

Patient Experience with Rechargeable Implantable Pulse Generator Deep Brain Stimulation for Movement Disorders.

BACKGROUND/AIMS: Nonrechargeable deep brain stimulation implantable pulse generators (IPGs) for movement disorders require surgical replacement every few years due to battery depletion. Rechargeable IPGs reduce frequency of replacement surgeries and inherent risks of complications but require frequent recharging. Here, we evaluate patient experience with rechargeable IPGs and define predictive characteristics for higher satisfaction. METHODS: We contacted all patients implanted with rechargeable IPGs at a single center in a survey-based study. We analyzed patient satisfaction with respect to age, diagnosis, target, charging duration, and body mass index. We tabulated hardware-related adverse events. RESULTS: Dystonia patients had significantly higher satisfaction than Parkinson's disease patients in recharging, display, programmer, and training domains. Common positive responses were "fewer surgeries" and "small size." Common negative responses were "difficulty finding the right position to recharge" and "need to recharge every day." Hardware-related adverse events occurred in 21 of 59 participants. CONCLUSION: Patient experience with rechargeable IPGs was largely positive; however, frustrations with recharging and adverse events were common. Dystonia diagnosis was most predictive of high satisfaction across multiple categories, potentially related to expected long disease duration with need for numerous IPG replacements.

Fixed-Life or Rechargeable Battery for Deep Brain Stimulation: Which Do Patients Prefer?

BACKGROUND: Deep brain stimulation (DBS) is increasingly used to treat a wide variety of neurological and psychiatric disorders. Implantable pulse generators (implantable pulse generators/batteries) for DBS were originally only available as a nonrechargeable option. However, there is now a choice between fixed-life and rechargeable batteries, with each having their own advantages and disadvantages. The extent of patient involvement in the choice of battery and the factors that matter to them have not been well studied. METHODS: Thirty consecutive adult patients with movement disorders attending a pre-DBS clinic were offered a choice of fixed-life or rechargeable battery and completed a questionnaire after the consultation on which factors influenced their decision. RESULTS: Nineteen patients (63%) chose the fixed-life battery and 11 patients (37%) chose the rechargeable battery. There were no significant differences in age, sex, underlying disease, disease duration or Unified Parkinson's Disease Rating Scale (UPDRS) (part 3) score (for patients with Parkinson disease) between those who chose the fixed-life vs. rechargeable battery. Most patients were not concerned about the size of the battery. Equal numbers were concerned about surgery to replace the battery, and less than half were concerned about the need to recharge the battery. More than half of patients felt that an acceptable charging frequency was monthly or yearly, and all patients felt that an acceptable charging duration was less than 1 hour, with half of all patients choosing less than 30 min. The main reasons cited for choosing the fixed-life battery were convenience and concern about forgetting to recharge the battery. The main reason for choosing the rechargeable battery was the avoidance of further surgery. DISCUSSION: Most patients in this adult cohort with movement disorders chose the fixed-life battery. The better lifestyle associated with a fixed-life battery is a major factor influencing their choice. Rechargeable batteries may be more acceptable if the recharging process is improved, more convenient, and discreet. CONFLICT OF INTEREST: The authors' institution has received educational grants from Medtronic, Abbott, and Boston Scientific companies.

A Submammarian Approach for Cosmetically Improved Implantation of Deep Brain Stimulation Generators.

BACKGROUND: Deep brain stimulation (DBS) indications include movement disorders, psychiatric affections, or epilepsy in which patients risk social isolation heightened by abnormal motions or behavioral patterns. Further stigmatization after DBS surgery from head shaving, visible scarring, or disfigurement from bulky lead insertion points should be avoided. OBJECTIVE: We present a cosmetically optimized, adapted submammarian approach for DBS neurostimulator implantation that leaves the décolletage untouched. METHODS: Over 24 months, 61 patients suffering from Parkinson disease, dystonia, or tremor underwent DBS surgery. The modified, submammarian approach was compared with the conventional infraclavicular approach regarding clinical outcome, complications, and limitations over a 5-year follow-up. RESULTS: Neurostimulators were implanted in a paraumbilical (n = 20) or infraclavicular position (n = 41; Parkinson disease, n = 27; dystonia, n = 9; tremor, n = 5), the latter using a standard (n = 16), modified juxta-axillary (n = 6), or submammarian approach (n = 19; 18 women, 1 man with significant gynecomastia). After 12 months, there was no significant difference in the infection rate and one event of rebleeding in each group. Overall, operation time was longer (+20 minutes) for the submammarian versus standard, infraclavicular approach, but acceptable. Neurostimulator replacement was, necessary within 5 years due to advanced battery discharge (n = 32). Battery replacement was easily achieved using the submammarian approach (n = 14), again with increased surgical time (+20 minutes), and iatrogenic damage to extensions was avoidable. CONCLUSIONS: A submammarian approach might be an alternative for infraclavicular implantation of DBS neurostimulators, particularly in female patients in the context of cosmetically optimized surgery. Patients' self-perception and self-esteem may be strengthened, potentially enabling them to better cope with disease.

Patients' preferences for headache acute and preventive treatment.

BACKGROUND: We aimed to explore patients' preferences for headache treatments with a self-administered questionnaire including the Q-No questionnaire for nocebo. METHODS: Questionnaires from 514 outpatients naïve to neurostimulation and monoclonal antibodies were collected. RESULTS: Patients assessed that the efficacy of a treatment is more important than safety or route of administration. They preferred to use an external neurostimulation device for both acute (67.1%) and preventive treatment (62.8%). Most patients preferred to take a pill (86%) than any other drug given parenterally for symptomatic pharmaceutical treatment. For preventive pharmaceutical treatment, most patients preferred to take a pill once per day (52%) compared to an injection either subcutaneously or intravenously each month (9% and 4%), or three months (15% and 11%). 56.6% of all participants scored more than 15 in Q-No questionnaire indicating potential nocebo behaviors that contributed significantly in their choices. CONCLUSION: These patient preferences along with efficacy and safety data may help physicians better choose the right treatment for the right person.

Protocolo psicológico para la evaluación de candidatos a implante de neuroestimulador / Psychological protocol for evaluation of candidates a neurostimulator

El presente artículo de revisión describe el Protocolo Psicológico para la evaluación de pacientes candidatos a implante de neuromodulación que se realiza en la Unidad Multidisciplinar de tratamiento del Dolor del Hospital Universitario y Politécnico la Fe de Valencia. Se recogen datos sobre factores cognitivos, emocionales y sensoriales. Se realiza un dictamen inicial: positivo, parcialmente negativo o negativo. Los pacientes con dictamen positivo realizan una terapia de preparación de modalidad grupal y muy estructurada, acompañados por un colaborador ya implantado en la Unidad. En esta terapia se abordan aspectos sobre fisiopatología del dolor, aspectos psicológicos del dolor y aspectos técnicos. Se incide sobre todas aquellas creencias y expectativas que tiene el paciente sobre el implante y se procede a la segunda parte, el protocolo quirúrgico, y a incluir en lista de quirófano. El protocolo presentado está demostrando ser un instrumento valioso para discriminar a pacientes idóneos, siendo de especial relevancia la preparación psicológica (AU)

This review article describes the Psychological Protocol for the evaluation of candidates for neuromodulation implant to be held in the Multidisciplinary Pain Treatment Unit at the University and Polytechnic Hospital 'La Fe', in Valencia. Data on cognitive, emotional and sensory factors are collected. An initial opinion is made: positive, negative or partly negative. Patients with positive opinion make a therapy and highly structured group preparation form, accompanied by a collaborator already implanted in this Unity. In this therapy, aspects of pathophysiology of pain, psychological aspects of pain and technical issues are addressed. It impinges on all beliefs and expectations of the patient on the implant and proceeds to the second part, the Surgical Protocol, and to include in the operating room list. The protocol presented is proving to be a valuable tool to discriminate eligible patients, being particularly important psychological preparation (AU)

Bizarre Paranoid Delusions Associated With an Implanted Surgical Device.

We describe a case involving bizarre paranoid delusions following implantation of a sacral nerve stimulator, and review the literature regarding psychotic symptoms related to surgical implants. A 64-year-old female developed bizarre paranoid delusions regarding a sacral nerve stimulator that had been implanted two years previously for dysfunctional voiding. The patient believed that the wires from the sacral nerve electrodes had grown up her spine and were affecting her vision as well as controlling her thoughts. The delusions developed in the setting of profound anxiety and feelings of loss after the death of her mother. The patient initially demanded that the implant be removed emergently. The delusions gradually abated as she adjusted to the loss of her mother. Fortunately the symptoms abated entirely with supportive care. We suspect that given the frequency of surgical implants that the association with delusional thoughts might be much higher than suggested by a literature review.

Long-term outcomes of spinal cord stimulation with percutaneously introduced paddle leads in the treatment of failed back surgery syndrome and lumboischialgia.

OBJECTIVE: The study aims to evaluate the long-term clinical and technical efficacy of recently developed percutaneously introducible plate electrodes for spinal cord stimulation. METHODS: Twenty-one patients diagnosed with failed back surgery syndrome (FBSS) or lumboischialgia were implanted with a small profile plate-type electrode. Patients were followed-up long term and were asked at baseline, after trial, and during each follow-up visit to score their pain on a visual analog scale (VAS) for pain now, worst pain last week, least pain last week, and mean pain last week. Pain location, electrophysiologic parameters, and number of reprogrammings were collected as well. Furthermore, each patient was asked if he/she would redo the procedure post trial and at each of the follow-up visits. RESULTS: A total of 21 patients were prospectively followed up long term. With a mean follow-up of 40.8 months, a significant mean reduction in patient self-reported pain from baseline to postoperative of 75.79% pain reduction was seen at follow-up 1 and 62.52% at follow-up 2. A significant decrease was obtained for, respectively, pain at the present moment, VAS pain worst last week, VAS pain least last week, and VAS pain mean last week in comparison with baseline VAS scores. All patients indicated that they would redo the procedure. CONCLUSION: Percutaneous implantation of small profile paddle leads in patients with FBSS and lumboischialgia produces favorable results over the long term that are at least comparable with surgical implanted paddle leads. The percutaneous approach also allows nonsurgically trained pain physicians to introduce paddle leads. Indices like if patients would redo the procedure may be more appropriate for analyzing long-term outcomes than the arbitrarily taking 50% reduction in VAS scores.