Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing

Evaluation of the Percutaneous Spinal Cord Stimulation Trial Using the Dermatomal Somatosensory Evoked Potentials (DSSEP) Collision Testing

This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.

Study Overview

• Status: Terminated
• Conditions: Back Pain With Radiation
• Intervention / Treatment: Device: DSSEP

Detailed Description

The SCS trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. Leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). After the leads are secured, the patient will be sent to the recovery room where the DSSEP test will be performed. A technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. One or two stimulating electrodes are also placed on the patient's leg. Each electrode is checked with a meter to ensure proper functioning. Pulsing stimulus will start in one of the stimulating electrodes. Each time a different area is tested, the pulsing will be started again. Each area tested will take 10-15 minutes. The painful dermatomal distribution area, specific to each patient will be used for dermatomal SSEP stimulation. Placement will be correlated with nerve roots involved with the corresponding dermatomes. Measurements will be obtained to determine collision criteria.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • University of Toledo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all the following criteria apply:

A. Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities.

B. Subjects are male or female greater than 18 years old at the time of screening visit.

C. Pain in one or both lower extremities. D. Pain is not responding to conservative treatment such as physical therapy or medications.

E. Average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study.

F. Patient is mentally competent to make decisions.

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

A. Female subject with childbearing potential (a premenopausal female, who is not surgically sterile).

B. Subjects who poorly cooperate or have any cognitive impairment. C. Patient with severe concomitant depression. D. Inability to communicate adequately with physician and /or study coordinator.

E. Patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSSEP; DSSEP testing after SCS trial lead placement	Device: DSSEP; Collision testing after the placement of SCS leads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Positive Collision	Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.	Day 1

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Investigators: Principal Investigator: Joseph N Atallah, MD, Universtiy of Toledo

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2016
• Primary Completion (Actual): December 7, 2016
• Study Completion (Actual): November 9, 2017

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: February 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: low back pain; leg pain; lumbago
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: Atallah SCS DSSEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The study was terminated early due to lack of enrollment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No