Recruiting

Spinal Cord Stimulation

Sponsor:

University of Minnesota

Code:

NCT04938245

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulation

Study Details

Brief 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

Chronic Pain

Study ID

NCT04938245

Start date

Aug 18, 2021

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Medically stable as determined by the principal investigator
  • Scheduled to undergo externalization of spinal cord stimulation
  • English-speaking

Exclusion Criteria:

  • Scheduled for permanent implantation only without trial
  • Have pacemakers or other neurostimulators
  • Pregnancy

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

Observed Cohort

Participants with chronic pain scheduled to undergo externalized trial for assessment of spinal cord stimulation will undergo intraoperative stimulation and up to three postoperative visits where already externalized electrodes (used clinically for stimulation) will be used to record and stimulate using evoked complex action potentials (ECAPs) while also measuring other electrophysiological responses.

Interventions

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.

Primary outcome measure

  • Feasibility Assessed by Enrollment [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

David Darrow, MD, MPH

(612)-634-6666darro015@umn.edu

Alexander Herman, MD, PhD

612-625-1194herma686@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-12-17.