Back to resultsEvaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing
Primary Purpose
Back Pain With Radiation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSSEP
Sponsored by
About this trial
This is an interventional diagnostic trial for Back Pain With Radiation focused on measuring lumbago, low back pain, leg pain
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
Sites / Locations
- University of Toledo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DSSEP
Arm Description
DSSEP testing after SCS trial lead placement
Outcomes
Primary Outcome Measures
Number of Participants With Positive Collision
Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.
Secondary Outcome Measures
Full Information
NCT ID
NCT02614079
First Posted
November 23, 2015
Last Updated
February 19, 2018
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT02614079
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment. Futility.
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
December 7, 2016 (Actual)
Study Completion Date
November 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain With Radiation
Keywords
lumbago, low back pain, leg pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSSEP
Arm Type
Experimental
Arm Description
DSSEP testing after SCS trial lead placement
Intervention Type
Device
Intervention Name(s)
DSSEP
Intervention Description
Collision testing after the placement of SCS leads
Primary Outcome Measure Information:
Title
Number of Participants With Positive Collision
Description
Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph N Atallah, MD
Organizational Affiliation
Universtiy of Toledo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study was terminated early due to lack of enrollment.
Learn more about this trial
Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing
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