Actively Recruiting
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S
Led by University of California, San Francisco · Updated on 2025-07-08
12
Participants Needed
1
Research Sites
52 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
Researchers are evaluating a new deep brain stimulation (DBS) therapy for adults with treatment-resistant chronic pain. Chronic pain affects many adults and is often difficult to treat with existing methods. This study focuses on improving DBS by targeting multiple brain regions involved in different pain aspects and using adaptive stimulation to potentially provide longer-lasting relief. The study uses advanced devices (Medtronic Summit RC+S or Percept RC) to deliver personalized, closed-loop DBS that responds to real-time brain signals. Participants undergo an inpatient trial with temporary electrode implants in several brain areas related to pain. Those who respond positively may receive permanent implants targeting up to three optimal regions. The study compares closed-loop DBS to traditional continuous stimulation and sham treatment in a randomized, single-blind crossover design. Participants will be closely monitored with brain recordings, pain and mood assessments, and sensory testing over two years. Researchers will measure pain intensity using a visual analog scale and assess quality of life, pain thresholds, and neuropathic pain symptoms. The study aims to develop personalized stimulation algorithms and evaluate their safety and effectiveness in reducing chronic pain.
CONDITIONS
Brief Title
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 to 80 years old
- Clinical diagnosis of refractory chronic pain syndrome such as 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 that is resistant to treatment
- Average daily pain above 6 on a 0-10 numeric rating scale in the past 30 days
- Pain fluctuates by at least 3 points on the numeric rating scale
- Failed at least two pain medications from different classes with stable doses for 30 days
- No surgically correctible cause of pain as determined by two independent surgeons
- Ability to speak and read English
- Able to provide informed consent
- Montreal Cognitive Assessment (MoCA) score of 25 or higher
- 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, immunocompromised state, or cancer with less than 5 years life expectancy
- Presence of incompatible implanted devices like pacemakers, defibrillators, medication pumps, or intracranial implants
- Pregnancy or breastfeeding
- Active depression with high Beck Depression Inventory score, recent suicide attempt, or uncontrolled psychiatric illness
- History of substance abuse in the past 3 years
- Inability to stop blood thinning medications for surgery
- Implant hardware not compatible with MRI or study devices
- MRI abnormalities suggesting other diagnoses or contraindicating surgery
- Previous cranial ablative or incompatible deep brain stimulation surgery
- Major neurological disorders other than the pain cause, including epilepsy or neurodegenerative diseases
- Need for treatments like diathermy, electroconvulsive therapy, or transcranial magnetic stimulation
- Allergies or sensitivity to study device materials
- Other conditions increasing risk or reducing likely benefit as judged by the principal investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Inpatient trial period (duration not specified)
Participants undergo bilateral surgical implant of temporary electrodes in multiple brain regions associated with pain to identify biomarkers and optimal stimulation parameters.
Inpatient stay for surgical implantation and monitoring
Duration - Up to 2 years
Participants receive closed-loop deep brain stimulation using implanted devices, with periods of active and inactive stimulation in a randomized crossover design to evaluate efficacy.
Weekly visits during closed-loop DBS blocks
Duration - Up to 2 years
Participants are assessed for long-term effects of DBS including pain, mood, and functional outcomes.
Periodic follow-up visits over 2 years
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
P
Prasad Shirvalkar, M.D., Ph.D
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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