Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial
Needleless Transcutaneous Neuromodulation Accelerates Postoperative Recovery Mediated via Autonomic and Immuno-Cytokine Mechanisms in Patients With Cholecystolithiasis.
Postsurgical gastrointestinal disturbance is clinically characterized by the delayed passage of flatus and stool, delayed resumption of oral feeding, dyspepsia symptoms, and postsurgical pain. This study was designed 1) to evaluate the effects of needleless transcutaneous neuromodulation (TN) on postoperative recovery; 2) to investigate mechanisms of the TN involving autonomic functions in postoperative patients after removal of the gallbladder. ⋯ In conclusion, the proposed needleless TN accelerates postoperative recovery after LC, possibly mediated via the autonomic and immune-cytokine mechanisms. Needleless and self-administrable TN may be an easy-to-implement and low-cost complementary therapy for postoperative recovery.
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Randomized Controlled Trial
Does Bilateral Deep Brain Stimulation of the Subthalamic Nucleus Modify Ano-Rectal Motility in Parkinson's Disease? Results of a Randomized Cross-Over Study.
Ano-rectal motility impairment is often observed during Parkinson's disease (PD), generating symptoms as constipation and/or incontinence with impaired quality of life. Subthalamic nuclei (STN) deep brain stimulation (DBS) improves motor symptoms of PD, but its effects on anorectal motility are unknown. This study aimed to assess the effects of STN-DBS on the anorectal motility in PD patients, in a randomized cross-over study. ⋯ STN-DBS increased anal squeezing pressure, but did not modify anorectal dyssynergia in PD patients, This study demonstrated the involvement of STN in the voluntary control of anorectal motility in PD patients.
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Randomized Controlled Trial Multicenter Study Comparative Study
Multicenter, Randomized, Double-Blind Study Protocol Using Human Spinal Cord Recording Comparing Safety, Efficacy, and Neurophysiological Responses Between Patients Being Treated With Evoked Compound Action Potential-Controlled Closed-Loop Spinal Cord Stimulation or Open-Loop Spinal Cord Stimulation (the Evoke Study).
The spinal cord (SC) response to stimulation has yet to be studied in a pivotal clinical study. We report the study design of an ongoing multicenter, randomized, double-blind, controlled, parallel-arm study of an evoked compound action potential (ECAP) controlled closed-loop spinal cord stimulation (SCS) system, which aims to gain U.S. Food and Drug Administration approval. ⋯ All approved SCS therapies, regardless of the presence or absence of stimulation induced paresthesias, produce fixed-output stimuli; that is, the energy delivered from the electrode array has a defined output irrespective of the neural response of SC fibers. An SCS system has been developed that directly measures the neurophysiologic activation of the SC to stimulation (i.e., ECAP amplitude) and uses this information in a feedback mechanism to produce closed-loop SCS to maintain optimal and stable activation of the SC. This study represents the first randomized, double-blind, pivotal study in the field of neuromodulation to measure SC activation in ECAP-controlled closed-loop versus open-loop stimulation and is expected to yield important information regarding differences in safety, efficacy, and neurophysiological properties. The potential clinical utility of these objective measurements of SC activation and other neurophysiological properties promises to improve outcomes of SCS for chronic pain patients.
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Randomized Controlled Trial
Effects of Multiple Waveforms on Patient Preferences and Clinical Outcomes in Patients Treated With Spinal Cord Stimulation for Leg and/or Back Pain.
We present the results of a prospective, randomized, crossover, single-blind, study in which each patient is in control of himself. The aim was to evaluate subperception-based (SP-SCS) waveforms in previously implanted spinal cord stimulation (SCS) patients with leg and/or back pain due to failed back surgery syndrome, who experienced only paresthesia-based stimulation (PB-SCS). Patients with PB-SCS experience in SCS was 4.7 years (SD 2.9). ⋯ There was a high heterogeneity regarding waveform preference, with patients who preferred to feel the tingling sensation and those who chose a SP-SCS option, mainly for greater pain relief. In general, SCS is successful, resulting in high pain relief, improvements in quality of life, and little depression. Overall, 42% patients benefited from the novel SP-SCS stimulation waveforms.
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Randomized Controlled Trial
Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial.
The burst waveform, a recent innovation in spinal cord stimulation (SCS), can achieve better outcomes than conventional tonic SCS, both for de novo implants and as a salvage therapy. Burst stimulation delivers more energy per second than tonic stimulation, which is a consideration for battery consumption. The clinical effectiveness of an energy-conserving strategy was investigated. ⋯ These results suggest that the use of energy-efficient burst microdosing stimulation paradigms with alternating stimulation-on and stimulation-off periods can provide clinically equivalent results to standard burst stimulation. This is important for extending SCS battery life. Further research is needed to comprehensively characterize the clinical utility of this approach and the neurophysiological mechanisms for the maintenance of pain relief during stimulation-off periods.