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Improving Spinal Cord Stimulation With ECAPS

NCT04938245 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-12-17

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Spinal 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.

Sponsors & Collaborators

Principal Investigators

  • David Darrow, MD, MPH · University of Minnesota Medical School Department of Neurosurgery

  • Alexander Herman, MD, PhD · University of Minnesota Medical School Department of Psychiatry

  • Tay Netoff, PhD · University of Minnesota Department of Biomedical Engineering

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938245 on ClinicalTrials.gov