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Intradural Percutaneous Stimulation

NCT03380104 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-05-11

No results posted yet for this study

Summary

The purpose of the study is to test the effects of intradural, spinal cord stimulation using a device placed in the same manner as a lumbar drain performed during a standard epidural spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation device implantation.

Conditions

  • Pain, Chronic

Interventions

DEVICE

Intradural Spinal Cord Stimulation

The device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal CSF space and advanced to the T8-10 disc space. After positioning of the intrathecal lead, the stimulation catheter will be run through a standardized experimental algorithm consisting on various frequencies.

BEHAVIORAL

Administration of Questionnaires

Subjects will be administered questionnaires to evaluate pain, quality of life, and global function prior the study, at 1 hour after the completion of the study, and at 4 day follow-up appointment.

Sponsors & Collaborators

  • Matthew Howard

    lead OTHER

Principal Investigators

  • Matthew A Howard, MD · University of Iowa

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03380104 on ClinicalTrials.gov