A novel neuromodulation technique in the treatment of chronic pain.
Completed
- Conditions
- Chronic Neuropathic Pain
- Registration Number
- NL-OMON26726
- Lead Sponsor
- Spinal Modulation, Inc.1135 O'Brien Dr.Menlo Park, CA 94025USA
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Male or female ≥ 18 years old;
2. Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months;
Exclusion Criteria
1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control;
2. Escalating or changing pain condition within the past month as evidenced by investigator examination;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Device Safety as determined by adverse event reporting. Adverse event profiles are expected to be similar to currently approved devices. These can include infection, lead migration, etc;<br /><br>2. Device Performance as indicated by programmed outputs and the ability of the subject to control paresthesias.
- Secondary Outcome Measures
Name Time Method 1. Pain relief (VAS);<br /><br>2. Quality of Life (EQ-5D).