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.
Visual Analog Score
Visual Analog Score is indicated by the patient by marking a 10 cm line as they rate their pain intensity from 0 to 100 in mm.
Short Form 36 Health Survey
The Short Form 36 Health Survey is a measure of health and functional status, and consists of a 36 question survey with eight scaled scores commonly used in Pain research. Each scaled score is scaled from 0-100 with 0 being the lowest/worst outcome and 100 being the highest/best outcome.
Quantitative Sensory Testing Pain Threshold
The Quantative Sensory Testing machine is described in the research protocol, and uses thermal stimuli to measure pain sensitivity and thresholds which may change with time or therapy. Thermal stimuli down to 0 degrees F. and up to 55 degrees F are given and patients are asked to report their pain either qualitatively or quantitatively using numerical rating scale from 0 to 10, with 0 being the lowest/no pain, and 10 being the worst.
Neuropathic Pain Questionnaire
The Neuropathic pain Questionnaire (NPQ) is an assessment instrument for neuropathic pain intensity and quality. It contains 12 items: 10 related to sensations or sensory responses and two related to affect. The items are totaled and rated out of 12, with 12 being in the most neuropathic pain.
Becks Depression Inventory
The Becks Depression Inventory is commonly used assessment tools to quantify and track depression mood state over time. Its a single value outcome measurement ranging from 0 to 63, with 63 being the most depressed.
Becks Anxiety Inventory
The Becks Anxiety Inventory is commonly used assessment tools to quantify and track anxious mood state over time.Its a single value outcome measurement ranging from 0 to 63, with 63 the most anxious.
NIH PROMIS toolbox (Patient Impression)
The NIH PROMIS toolbox contains a host of survey questions tailored to measurement of specific disease states such as pain, global health and function. The patient impression evaluates patient self-evaluation and physician evaluation of the patient's general health ranging form 0 to 7 with 7 being the worst general health.
Pain medication usage
We will calculate total number of of breakthrough pain medication pills (eg. opioids, NSAIDs and neuropathic pain medication) used each month, to evaluate if analgesia from DBS reduces average usage.
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
