RecruitingNCT04938245

Improving Spinal Cord Stimulation With ECAPS

Sponsor

University of Minnesota

Enrollment

15 participants

Start Date

Aug 18, 2021

Study Type

OBSERVATIONAL

Conditions

Chronic Pain

Summary

The purpose of this study will be to investigate the optimization of spinal cord stimulation with ECAPs in patients with spinal cord implants.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This observational study explores how evoked compound action potentials (ECAPs) — electrical signals recorded from the spinal cord in response to stimulation — can provide real-time feedback to optimize spinal cord stimulation (SCS) therapy for patients with chronic pain. ECAPs may allow doctors to adjust the stimulation more precisely to each patient's changing position and physiology, potentially improving pain relief. Adults who are medically stable, scheduled for an externalization trial of spinal cord stimulation, and are English-speaking are eligible, excluding those with pacemakers or pregnancy. Participation involves ECAP recordings during the externalization period (when the device is tested externally before permanent implantation) while the patient continues their standard SCS trial. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpinal Cord Stimulation

Intraoperatively, stimulation at 12 Hz will be performed as the leads are moved into the targeted position. Amplitude will be increased to 15 mA maximum total until a response is seen on any electrode and held for 10 seconds. Stimulation and recording will be performed using the Neuralynx stim/record system. Post-operatively, the electrodes will be tested for impedance by the clinical system and then they will be connected to the Neuralynx stim/record system. Electrode stimulation patterns will be applied with increasing amplitude until ECAPs responses are seen on recording electrodes. 42 Hz stimulation will be performed with an amplitude sweep of 0mA-10mA. At each amplitude, stimulation will be applied for 4 seconds followed by 2 seconds of rest. Pulse width will be varied from 30-450 microseconds to test effective amplitude. Bursting stimulation will be applied to detect differences in ECAPs as above.