Clinical trial NCT02614079: Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing
Official title: Evaluation of the Percutaneous Spinal Cord Stimulation Trial Using the Dermatomal Somatosensory Evoked Potentials (DSSEP) Collision Testing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Back Pain With Radiation
Keywords: lumbago
low back pain
leg pain
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Participants With Positive Collision
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
Study officials:
affiliation: Universtiy of Toledo
name: Joseph N Atallah, MD
role: PRINCIPAL_INVESTIGATOR
References: