NCT02614079

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Toledo Health Science Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Back Pain With Radiation

Interventions

Type	Name	Description
DEVICE	DSSEP	Collision testing after the placement of SCS leads

Timeline

• Start date: 2016-01-20
• Primary completion: 2016-12-07
• Completion: 2017-11-09
• First posted: 2015-11-25
• Last updated: 2018-03-15
• Results posted: 2018-02-19

Locations

1 site across 1 country: United States