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.
Age 22-80 years old
Clinical diagnosis of a refractory chronic pain syndrome including
post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury)
postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain)
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
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
Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
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.
Crossover
Medtronic Summit RC+S or Percept RC
DeviceThe investigators will perform DBS versus sham (randomized) to evaluate efficacy of stimulation for analgesia. Closed-loop DBS will be compared to open-loop DBS in a patient blinded, randomized fashion after initial, efficacy evaluation.
Feasibility of identifying personalized physiological biomarkers and an optimal stimulation site during the temporary (externalized) trial stage
Identifying biomarkers in machine learning models that exceed chance and stimulation sites that provide clinically meaningful reductions in chronic pain during a temporary brain stimulation and recording period in hospital
Feasibility of implementing individualized closed-loop DBS for chronic pain
Safety and Rate of Adverse Events
Quantifying the rate and category of all adverse events
Pain Numerical Rating Scale Improvement - Exploratory
Quantifying percent improvement and absolute improvement on Numerical Rating Scale (NRS) 0-10 scale of pain severity,
Pain Visual Analog Scale improvement - Exploratory
Quantifying percent improvement and absolute improvement on Visual Analog Scale (VAS) 0-100 scale of pain severity
McGill Pain Questionnaire Improvement - Exploratory
Quantifying percent improvement and absolute improvement on McGill Pain Questionnaire (short form - version 2)
Health related quality of life
Quantifying change in multiple quality-of-life measures with the short form 36, including physical, emotional, and pain-related sub-scores from baseline to long-term follow-up.
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
