About this trial

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

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Medtronic Summit RC+S or Percept RC

Treatment groups

12 Participants
are divided into 2 treatment groups

Locations

1
University of California, San Francisco94143, San FranciscoCalifornia, United States

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator