NCT06499220

Brief Summary

This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

June 18, 2024

Last Update Submit

July 8, 2024

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.

    The ECAP data collected is prototype system/device information for development of a closed loop system.

    1 hour to 72 hours

Study Arms (1)

ECAP Recording

EXPERIMENTAL
Device: Spinal Cord Stimulator

Interventions

Spinal Cord StimulatorDEVICE

Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

ECAP Recording

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Candidate for or undergoing Medtronic SCS device trial for labeled indication\*
  • Willing and able to provide signed and dated informed consent
  • Capable of comprehending and consenting in English
  • Willing and able to comply with all study procedures and visits \*Candidate for or undergoing Medtronic SCS device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic SCS trialing to treat the patient's chronic pain. This decision is to be made prior to discussing with the patient whether to enroll in the study.

You may not qualify if:

  • Implanted electrical cardiac device (e.g., pacemaker, defibrillator)
  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
  • Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
  • Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
  • Has untreated major psychiatric comorbidity, as determined by the investigator or designee
  • Trialed with a permanent implant lead and extension ("buried lead trial")

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Coastal Pain and Spinal Diagnostics

Carlsbad, California, 92009, United States

Location

MercyOne Des Moines Medical Center

Des Moines, Iowa, 50314, United States

Location

Nura Research Institute

Edina, Minnesota, 55435, United States

Location

Twin Cities Pain Clinic

Edina, Minnesota, 55439, United States

Location

iSpine Pain Physicians

Maple Grove, Minnesota, 55369, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Kettering Health

Kettering, Ohio, 45429, United States

Location

Premier Pain Treatment Institute

Mount Orab, Ohio, 45154, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

Rockefeller Neuroscience Institute West Virginia University

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 12, 2024

Study Start

October 30, 2019

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

US(10)