Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing

NCT ID: NCT02614079

Last Updated: 2018-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2017-11-09

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.

Conditions

Back Pain With Radiation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DSSEP

DSSEP testing after SCS trial lead placement

Group Type: EXPERIMENTAL

DSSEP

Intervention Type: DEVICE

Collision testing after the placement of SCS leads

Interventions

DSSEP

Collision testing after the placement of SCS leads

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toledo Health Science Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph N Atallah, MD

Role: PRINCIPAL_INVESTIGATOR

Universtiy of Toledo

Locations

University of Toledo

Toledo, Ohio, United States

Countries

United States

Other Identifiers

Atallah SCS DSSEP

Identifier Type: -

Identifier Source: org_study_id