Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing (NCT02614079) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing
Stopped: Lack of enrollment. Futility.
United States6 participantsStarted 2016-01-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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