Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing
Stopped early · Not applicable
Conditions studied: Back Pain With Radiation
In brief
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.
Key facts
- Study ID
- NCT02614079
- Run by
- University of Toledo Health Science Campus
- People needed
- 6
- Starts
- 2016-01-20
- Expected to finish
- 2017-11-09
- Last updated by the study team
- 2018-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Toledo — Toledo, Ohio, United States
Full record on ClinicalTrials.gov
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