Actively Recruiting
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
Led by University of California, San Francisco · Updated on 2025-07-08
12
Participants Needed
1
Research Sites
574 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22-80 years old
- Diagnosis of refractory chronic pain syndrome including post-traumatic pain, postsurgical pain, postherpetic neuralgia, complex regional pain syndrome, atypical facial pain, central pain syndromes, or post-radiation plexopathy
- Severe pain lasting two or more years despite medical treatment
- Average daily pain greater than 6 on a 0-10 numeric rating scale for the past 30 days
- Pain fluctuates by at least 3 points on the numeric rating scale
- Failure of at least two pain medications from different classes with stable doses for 30 days before baseline
- No surgically correctable cause of pain as confirmed by two independent surgeons
- Ability to read and speak English
- Capable of understanding and providing informed consent
- Montreal Cognitive Assessment score of 25 or higher indicating no significant cognitive impairment
- Successful detection of pain biomarkers or positive response to inpatient stimulation trial if performed
You will not qualify if you...
- Major medical conditions increasing surgical risk such as uncontrolled hypertension, coagulopathy, severe diabetes, major organ failure, active infection, immunocompromise, or malignancy with less than 5 years life expectancy
- Presence of incompatible implanted devices such as pacemakers, defibrillators, medication pumps, intracardiac lines, intracranial implants, or other stimulators not compatible with the study device
- Pregnancy or breastfeeding; women of childbearing potential must have a negative pregnancy test before surgery
- Active severe depression, recent suicide attempt within 12 months, imminent suicide risk, or untreated/uncontrolled psychiatric illness as determined by psychiatrist
- History of substance abuse in the past 3 years
- Inability to stop blood-thinning medications for surgery and recovery
- Implantable hardware incompatible with MRI or study requirements
- Brain MRI abnormalities suggesting alternative diagnosis or contraindicating surgery
- Previous cranial ablative surgery
- Previous DBS surgery using an incompatible system
- Major neurological disorders other than those causing chronic pain, including epilepsy or neurodegenerative conditions
- Need for diathermy, electroconvulsive therapy, or transcranial magnetic stimulation
- Allergies or hypersensitivity to materials in the study device
- Any condition judged by the principal investigator to increase risk or reduce benefit from DBS
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
C
Catherine Borror
CONTACT
P
Prasad Shirvalkar, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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