Neuromodulation : journal of the International Neuromodulation Society
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The United States Food and Drug Administration (FDA) ensures that patients in the United States have access to safe and effective medical devices. The division of neurological and physical medicine devices reviews medical technologies that interface with the nervous system, including many neuromodulation devices. This article focuses on neuromodulation devices and addresses how to navigate the FDA's regulatory landscape to successfully bring devices to patients.
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Randomized Controlled Trial
Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.
"Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely. ⋯ Using wireless SCS devices that allow for an extended trial period and evaluation of various waveforms, we observed a high rate trial success rate with both HFS and LFS waveforms, with minimal incidence of infection. Long-term follow-up will address the cost-effectiveness and morbidity associated with this technology, which facilitates single-stage treatment.
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Apart from the clinical efficacy of high frequency spinal cord stimulation at 10 kHz, the underlying mechanism of action remains unclear. In parallel with spinal or segmental theories, supraspinal hypotheses have been recently proposed. In order to unveil hidden altered brain connectome patterns, a resting state functional magnetic resonance imaging (rsfMRI) protocol was performed in subjects routinely treated for back and/or leg pain with high-frequency spinal cord stimulation (HF-SCS) HF-SCS at 10 kHz. ⋯ These findings support the hypothesis that HF-SCS at 10 kHz might influence the salience network and therefore also the emotional awareness of pain.
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We aim to investigate the correlation of smoking and spinal cord stimulation (SCS) effectiveness for pain relief in complex regional pain syndrome (CRPS) patients while controlling for possible confounding factors including opioid intake. ⋯ Tobacco cigarette smoking was associated with reduced SCS effectiveness for pain relief.
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Spinal cord stimulation (SCS) is considered an effective pain-relieving treatment for patients with Failed Back Surgery Syndrome (FBSS). Despite the clinical effectiveness, it is unknown whether the altered functional connectivity in such patients, as compared to healthy persons, can be influenced by SCS. Therefore, the goal of this study is to evaluate whether brain connectivity assessed by EEG differs between baseline and SCS in patients with FBSS. ⋯ The differences in power spectrum and connectivity between the three conditions lead to the hypothesis that HD SCS differs from CON SCS on average power spectrum, suggesting that HD SCS may have a higher contribution on the excitatory bottom-up pathway.