Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

‣ postherpetic neuralgia

‣ complex regional pain syndrome

‣ atypical facial pain

‣ central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain)

‣ post-radiation plexopathy

• Two or more years or more of medically refractory severe pain

• Average daily pain for the past 30 days reported as \>6 on a 0-10 numeric rating scale (NRS)

• Pain that fluctuates over a range of at least 3 points on the NRS

• 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.

• Lack of a surgically correctible etiology for the pain as determined by 2 independent surgeons

• Ability to speak / read English

• Capable of understanding and providing informed consent

⁃ Absence of significant cognitive impairment - score of 25 or greater on the Montreal Cognitive Assessment (MoCA)

⁃ Successful detection of pain biomarkers or positive symptomatic response to inpatient stimulation trial period if performed.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Catherine Borror
chronicpain@ucsf.edu
‪(415) 353-3494
Backup
Prasad Shirvalkar, M.D., Ph.D
Prasad.Shirvalkar@ucsf.edu
‪(415) 691-7587‬
Time Frame
Start Date: 2019-10-24
Estimated Completion Date: 2030-10-24
Participants
Target number of participants: 12
Treatments
Active_comparator: Active DBS
Chronic brain recordings and stimulation with bilateral implantations in pain-related brain regions. All participants will participate in active DBS, blinded to the participant.
Sham_comparator: Inactive DBS
Non-active chronic brain stimulation in pain-related brain regions. brain recordings will remain active during this period. All participants will participate in inactive DBS, blinded to the participant.
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov