Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing

NCT02614079 | Terminated Results

• 1 other identifier: Atallah SCS DSSEP
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain With Radiation

Keywords

lumbago; low back pain; leg pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Study Arms (1)

DSSEP

EXPERIMENTAL

DSSEP testing after SCS trial lead placement

Device: DSSEP

Interventions

DSSEP DEVICE

Collision testing after the placement of SCS leads

DSSEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. 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

Sponsors & Collaborators

• University of Toledo Health Science Campus: lead

Study Sites (1)

University of Toledo

Toledo, Ohio, 43614, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph Atallah, MD
• Organization: University of Toledo Medical Center

joseph.atallah@utoledo.edu

419-383-6699

Study Officials

• Joseph N Atallah, MD

  Universtiy of Toledo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: January 20, 2016
• Primary Completion: December 7, 2016
• Study Completion: November 9, 2017
• Last Updated: March 15, 2018
• Results First Posted: February 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)