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RECRUITING
NCT04938245

Improving Spinal Cord Stimulation With ECAPS

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2021-08-18

Completion Date

2026-12-31

Last Updated

2025-12-17

Healthy Volunteers

No

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.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States