A multicenter, open-label, controlled trial on acceptance, convenience, and complications of rechargeable internal pulse generators for deep brain stimulation: the Multi Recharge Trial

Restricted access

OBJECTIVE

Rechargeable neurostimulators for deep brain stimulation have been available since 2008, promising longer battery life and fewer replacement surgeries compared to non-rechargeable systems. Long-term data on how recharging affects movement disorder patients are sparse. This is the first multicenter, patient-focused, industry-independent study on rechargeable neurostimulators.

METHODS

Four neurosurgical centers sent a questionnaire to all adult movement disorder patients with a rechargeable neurostimulator implanted at the time of the trial. The primary endpoint was the convenience of the recharging process rated on an ordinal scale from “very hard” (1) to “very easy” (5). Secondary endpoints were charge burden (time spent per week on recharging), user confidence, and complication rates. Endpoints were compared for several subgroups.

RESULTS

Datasets of 195 movement disorder patients (66.1% of sent questionnaires) with Parkinson’s disease (PD), tremor, or dystonia were returned and included in the analysis. Patients had a mean age of 61.3 years and the device was implanted for a mean of 40.3 months. The overall convenience of recharging was rated as “easy” (4). The mean charge burden was 122 min/wk and showed a positive correlation with duration of therapy; 93.8% of users felt confident recharging the device. The rate of surgical revisions was 4.1%, and the infection rate was 2.1%. Failed recharges occurred in 8.7% of patients, and 3.6% of patients experienced an interruption of therapy because of a failed recharge. Convenience ratings by PD patients were significantly worse than ratings by dystonia patients. Caregivers recharged the device for the patient in 12.3% of cases. Patients who switched from a non-rechargeable to a rechargeable neurostimulator found recharging to be significantly less convenient at a higher charge burden than did patients whose primary implant was rechargeable. Age did not have a significant impact on any endpoint.

CONCLUSIONS

Overall, patients with movement disorders rated recharging as easy, with low complication rates and acceptable charge burden.

ABBREVIATIONS DBS = deep brain stimulation; IPG = internal pulse generator; MD = movement disorder; nr-IPG = non-rechargeable IPG; OCD = obsessive-compulsive disorder; PD = Parkinson’s disease; r-IPG = rechargeable IPG.

Downloadable materials

  • Appendix 1 (PDF 404 KB)

Article Information

Correspondence Martin Jakobs: University Hospital Heidelberg, Heidelberg, Germany. martin.jakobs@med.uni-heidelberg.de.

INCLUDE WHEN CITING Published online August 16, 2019; DOI: 10.3171/2019.5.JNS19360.

Disclosures Dr. Jakobs has received travel and educational grants from Abbott Inc. (previously St. Jude Medical). He gave educational talks for inomed GmbH, for which he received speaker fees. Dr. Helmers has received a travel grant from Medtronic. Dr. Slotty has received travel grants and speaker fees from Abbott Inc. (previously St. Jude Medical). Dr. Anthofer has received travel grants from Medtronic. Dr. Schlaier has received teaching honoraria from Medtronic and research support from the following companies: St. Jude Medical, Antisense Pharma, and Medtronic. He has recently given several talks that were partly sponsored by Medtronic, St. Jude Medical, or BrainLab and serves as a consultant to Medtronic and receives compensation for these services.

© AANS, except where prohibited by US copyright law.

Headings

Figures

  • View in gallery

    CONSORT flow diagram. Figure is available in color online only.

  • View in gallery

    Rating of the recharging process. Figure is available in color online only.

TrendMD

Metrics

Metrics

All Time Past Year Past 30 Days
Abstract Views 280 280 111
Full Text Views 53 53 21
PDF Downloads 47 47 22
EPUB Downloads 0 0 0

PubMed

Google Scholar