Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
Completed · Not applicable
Conditions studied: Pain, Chronic, Pain, Intractable, Pain, Back
In brief
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back. Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation System.
Key facts
- Study ID
- NCT04503109
- Run by
- Nalu Medical, Inc.
- People needed
- 110
- Starts
- 2020-07-16
- Expected to finish
- 2022-09-13
- Last updated by the study team
- 2023-02-15
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is between 21 and 80 years of age at enrollment.
- Subject has chronic (defined as at least 6 months duration), intractable neuropathic pain of legs and/or back; any nociceptive pain must be less prominent than the neuropathic pain.
- Subject's pain is unresponsive to conservative treatment options.
- Subject has a VAS Score of at least 6 in the back and/or leg at screening.
You may not qualify if…
- Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
- Subject has previously failed SCS therapy (either trial system evaluation or permanent implant).
- Subject has had an ablative procedure directed at the spinal cord including the dorsal root entry zone (DREZ) or dorsal root ganglion (DRG).
- Subject has pain in another anatomic region besides the leg(s) and back that would interfere with their ability to accurately report pain (e.g. hip joint pain).
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
Where it is running
- CA Ortho and Spine — Larkspur, California, United States
- IPM Medical Group, Inc. — Walnut Creek, California, United States
- International Spine, Pain and Performance Center — Washington D.C., District of Columbia, United States
- The Orthopaedic Institute — Gainesville, Florida, United States
- Southwest Florida Pain Center — Port Charlotte, Florida, United States
- Alliance Spine and Pain — Atlanta, Georgia, United States
- Neuroscience Research Center — Overland Park, Kansas, United States
- SSM Health — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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