Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing

Not Applicable

Terminated

• Conditions: Back Pain With Radiation
• Interventions: Device: DSSEP

• Registration Number: NCT02614079
• Lead Sponsor: University of Toledo Health Science Campus

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-25
• Study Start: 2016-01-20
• Primary Completion: 2016-12-07
• Study Completion: 2017-11-09
• Results First Submitted: 2017-12-05
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-19
• Results First Posted: 2018-02-19
• Last Update Submitted: 2018-02-19
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSSEP	DSSEP	DSSEP testing after SCS trial lead placement

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Collision	Day 1	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.

Trial Locations

Locations (1)

University of Toledo; 🇺🇸 Toledo, Ohio, United States