Can a smart brain implant outsmart chronic pain?
NCT ID NCT04144972
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial tests whether a new type of deep brain stimulation (DBS) can better relieve chronic pain that hasn't responded to other treatments. Unlike traditional DBS, which delivers constant stimulation, this approach uses a device that adapts stimulation in real time based on brain signals, targeting multiple pain-related regions. The study involves 12 adults with various chronic pain conditions and will compare adaptive (closed-loop) stimulation to standard (open-loop) and sham stimulation to see if it's more effective and safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Closed-loop deep brain stimulation (DBS) using the Medtronic Summit RC+S or Percept RC device
- What this could lead to
- If successful, this could lead to a more effective, personalized brain stimulation therapy for people with chronic pain that doesn't respond to other treatments.
- What could go wrong
- This is an early, small trial (12 participants) focused on feasibility, so results may not apply broadly. Risks include those of brain surgery and device implantation, such as infection or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 22-80 years old 2. Clinical diagnosis of a refractory chronic pain syndrome including 1. post-traumatic pain syndromes (e.g. root avulsions, nerve crush injuries, spinal cord injury) 2. postsurgical pain syndromes (e.g., postmastectomy syndrome, post-thoracotomy syndrome, phantom limb pain, post-surgical spinal pain) 3. postherpetic neuralgia 4. complex regional pain syndrome 5. atypical facial pain 6. central pain syndromes (e.g. post-stroke pain, multiple sclerosis pain, post-radiation pain) 7. post-radiation plexopathy 3. Two or more years or more of medically refractory severe pain 4. Average daily pain for the past 30 days reported as \>6 on a 0-10 numeric rating scale (NRS) 5. Pain that fluctuates over a range of at least 3 points on the NRS 6. 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. 7. Lack of a surgically correctible etiology for the pain as determined by 2 independent surgeons 8. Ability to speak / read English 9. Capable of understanding and providing informed consent 10. Absence of significant cognitive impairment - score of 25 or greater on the Montreal Cognitive Assessment (MoCA) 11. Successful detection of pain biomarkers or positive symptomatic response to inpatient stimulation trial period if performed. Exclusion Criteria: 1. 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 2. 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 3. Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure. 4. 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. 5. History of substance abuse in past 3 years 6. Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery. 7. Implantable hardware not compatible with MRI or with the study. 8. MR abnormalities that suggest an alternative diagnosis or contraindicate surgery 9. Previous cranial ablative surgery. 10. Previous deep brain stimulation surgery using an RC+S incompatible system 11. Major neurological disorder other than the one that led to the chronic pain including epilepsy or a neurodegenerative condition including inability to recharge the device. 12. Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) 13. Allergies or known hypersensitivity to materials in the Summit RC+S system 14. Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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