NCT04144972 Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
| NCT ID | NCT04144972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2019-10-24 |
| Primary Completion | 2029-10-24 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Chronic pain affects 1 in 4 US adults, and many cases are resistant to almost any treatment. Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but traditional approaches target only brain regions involved in one aspect of the pain experience and provide continuous 24/7 brain stimulation which may lose effect over time. By developing new technology that targets multiple, complimentary brain regions in an adaptive fashion, the investigators will test a new therapy for chronic pain that has potential for better, more enduring analgesia.
Eligibility Criteria
Inclusion Criteria: 1. Age 22-80 years old 2. Clinical diagnosis of a refractory chronic pain syndrome including 1. post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury) 2. postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain) 3. postherpetic neuralgia 4. complex regional pain syndrome 5. atypical facial pain 6. central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain) 7. post-radiation plexopathy 3. Two or more years or more of medically refractory severe pain 4. Average daily pain for the past 30 days reported as \>6 on a 0-10 numeric rating scale (NRS) 5. Pain that fluctuates over a range of at least 3 points on the NRS 6. Patient has failed at least two pain medications from different classes as determined by a neurologist or pain management specialist with stable doses of medications for 30 days prior to baseline visit. 7. Lack o