Improving Spinal Cord Stimulation With ECAPS

NCT04938245 | Recruiting FDA Device

• 1 other identifier: NEUROSURG-2021-29717
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility Assessed by Enrollment

  Feasibility will be measured as a number of the number of enrolled participants who complete at least 80% of the planned assessments.

  2 weeks

Secondary Outcomes (1)

• Acceptability Assessed by Survey

  2 weeks

Other Outcomes (4)

• Correlation of ECAP peak to peak signals to programming parameters

  2 weeks

• Correlation of ECAP signals to pain relief

  2 weeks

• Stability and reliability of ECAP sensing

  2 weeks

Study Arms (1)

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.

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

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.

Observed Cohort

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults scheduled to undergo externalization of spinal cord stimulation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (1)

• Konig S, Ramadan A, Sullivan D, Goel V, Stayner RS, Schultz D, Herman AB, Netoff TI, Darrow DP. Feature extraction and prediction of spinal cord stimulation evoked compound action potentials in humans. J Neural Eng. 2025 Apr 8;22(2). doi: 10.1088/1741-2552/adbfbe.

  PMID: 40073452 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• David Darrow, MD, MPH

  University of Minnesota Medical School Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Alexander Herman, MD, PhD

  University of Minnesota Medical School Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Tay Netoff, PhD

  University of Minnesota Department of Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Darrow, MD, MPH

CONTACT

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

Alexander Herman, MD, PhD

CONTACT

612-625-1194; herma686@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: August 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 years

Locations

US (1)