Chronic Neuropathic Pain
Conditions
Interventions
This intervention involves the placement of epidural leads that provide stimulation. Stimulation intensity and the amount of of stimulation during the day is controlled by the subject to the desired l
Sponsors
Spinal Modulation, Inc.
1135 O'Brien Dr.
Menlo Park, CA 94025
USA
Eligibility
Inclusion criteria
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; 3. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain; 4. Minimum baseline pain rating of 60 mm on the VAS; 5. Stable pain medication dosage for at least 30 days; 6. Stable neurologic function in the past 30 days.
Exclusion criteria
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; 3. Subject is currently involved in medically related litigation; 4. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump; 5. Subject currently has an active infection; 6. Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device; 7. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation; 8. Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 2. Device Performance as indicated by programmed outputs and the ability of the subject to control paresthesias. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain relief (VAS); 2. Quality of Life (EQ-5D). | — |
Contacts
Public ContactJeffery Kramer
Spinal Modulation, Inc. 1135 O'Brien Dr.
Outcome results
None listed