Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

Eligibility 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 of a surgically correctible etiology for the pain as determined by 2 independent surgeons
• 8. Ability to speak / read English
• 9. Capable of understanding and providing informed consent
• 10. Absence of significant cognitive impairment - score of 25 or greater on the Montreal Cognitive Assessment (MoCA)
• 11. Successful detection of pain biomarkers or positive symptomatic response to inpatient stimulation trial period if performed.
• 1. Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, coagulopathy, severe diabetes, major organ system failure, active infection or history of implant related infections, immunocompromised state or malignancy with \< 5 years life expectancy
• 2. Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators not compatible with RC+S system
• 3. Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
• 4. Active depression (BDI \> 20), Suicide attempt \</= 12 months or imminent suicide risk, or other untreated or uncontrolled psychiatric illness that evaluating psychiatrist would recommend exclusion of patient after neuropsychiatric evaluation.
• 5. History of substance abuse in past 3 years
• 6. Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery.
• 7. Implantable hardware not compatible with MRI or with the study.
• 8. MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
• 9. Previous cranial ablative surgery.
• 10. Previous deep brain stimulation surgery using an RC+S incompatible system
• 11. Major neurological disorder other than the one that led to the chronic pain including epilepsy or a neurodegenerative condition including inability to recharge the device.
• 12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
• 13. Allergies or known hypersensitivity to materials in the Summit RC+S system
• 14. Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.