Spinal Cord InjuriesNCT04144972
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
A study testing Medtronic Summit RC+S or Percept RC in people with Spinal Cord Injuries and Nerve Injury, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Nerve Injury, Pain, Postoperative
- What is being tested?
- Medtronic Summit RC+S or Percept RC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 24 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
- History of substance abuse in past 3 years
- Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery.
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- Implantable hardware not compatible with MRI or with the study.
- MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
- Previous cranial ablative surgery.
- Previous deep brain stimulation surgery using an RC+S incompatible system
- 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.
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
- Allergies or known hypersensitivity to materials in the Summit RC+S system
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S
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.
Read the detailed description
A diverse array of chronic pain syndromes are refractory to almost all treatment but involve pathological activity in similar brain regions. This suggests therapeutic potential for deep brain stimulation (DBS) for refractory pain disorders, but despite early promise, long-term efficacy is lacking. Current DBS devices are limited in anatomical reach, targeting only a subset of the distinct brain regions known to be important. Further, DBS therapy is bluntly applied in an "open-loop," continuous fashion without regard to underlying physiology. As a result of these shortcomings, DBS for pain is often ineffective or shows diminished effect over time. Loss of therapeutic effect may be due to nervous system adaptation or a failure of stimulation to accommodate patient- specific dynamics of pain processing. DBS could be significantly improved by seeking individually optimized brain targets or by using neural biomarkers of pain to selectively control stimulation when it is needed ("closed-loop" DBS). Better brain targets would also address the different dimensions of pain such as somatosensory (location, intensity and duration), affective (mood and motivation) and cognitive (attention and memory). The main goal of this study is to test the feasibility of personalized targeting of brain regions that support multiple pain dimensions and to develop new technology for "closed-loop" DBS for pain. The study team will develop data-driven stimulation control algorithms to treat chronic pain using a novel device (Medtronic Summit RC+S or Percept RC) that allows longitudinal intracranial signal recording in an ambulatory setting. By building this technology in an implanted device, chronic pain DBS is tailored to each patient and will advance precision methods for DBS more generally.
Beginning with an inpatient trial period, subjects with various refractory chronic pain syndromes will undergo bilateral surgical implant of temporary electrodes in the thalamus, anterior cingulate, prefrontal cortex, insula and amygdala. These regions have been implicated in the multiple dimensions of pain. The goal of the trial period is to identify candidate biomarkers of pain and optimal stimulation parameters for each individual, and to select subjects who show likelihood to benefit from the trial. A subgroup of 6 such patients will then proceed to chronic implantation of up to 3 "optimal" brain regions for long-term recording and stimulation. The invstigators will first validate biomarkers of low- and high-pain states to define neural signals for pain prediction in individuals (Aim 1). The investigators will then use these pain biomarkers to develop personalized closed-loop algorithms for DBS and test the feasibility of performing closed-loop DBS for chronic pain in weekly blocks (Aim 2). Finally, the investigators will assess efficacy of closed-loop DBS algorithms against sham (placebo) in a double-blinded crossover trial (Aim 3) and measure mechanisms of DBS tolerance. Our main outcome measures will be a combination of pain, mood and functional scores together with quantitative sensory testing. Successful completion of this study would result in the first algorithms to predict real-time fluctuations in chronic pain states and development of a new therapy for currently untreatable diseases.
- Conditions
- Spinal Cord Injuries, Nerve Injury, Pain, Postoperative, Post Herpetic Neuralgia, Complex Regional Pain Syndromes, Post-Stroke Pain
- Being tested
- Medtronic Summit RC+S or Percept RC
- Keywords
- Chronic Pain
- Medical subject headings
- Spinal Cord Injuries, Pain, Postoperative, Neuralgia, Postherpetic, Complex Regional Pain Syndromes, Radiculopathy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Summit RC+S or Percept RCDevice
The investigators will perform DBS versus sham (randomized) to evaluate efficacy of stimulation for analgesia. Closed-loop DBS will be compared to open-loop DBS in a patient blinded, randomized fashion after initial, efficacy evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Active DBS | Active comparator | Chronic brain recordings and stimulation with bilateral implantations in pain-related brain regions. All participants will participate in active DBS, blinded to the participant. Receives: Device: Medtronic Summit RC+S or Percept RC |
| Inactive DBS | Sham comparator | 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. Receives: Device: Medtronic Summit RC+S or Percept RC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of identifying personalized physiological biomarkers and an optimal stimulation site during the temporary (externalized) trial stage
Identifying biomarkers in machine learning models that exceed chance and stimulation sites that provide clinically meaningful reductions in chronic pain during a temporary brain stimulation and recording period in hospital
Measured: 60 days
Feasibility of implementing individualized closed-loop DBS for chronic pain
Measured: 2 years
Secondary outcomes (1)
Safety and Rate of Adverse Events
Quantifying the rate and category of all adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start24 Oct 2019
- Primary completion24 Oct 2029 (estimated)
- Study completion24 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will participate in the Stage 0, in-clinic evaluation period to assess potential effectiveness of trial. A subset of those enrolled will proceed into the rest of the Stages (1-3).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Prasad Shirvalkar, MD, PhD, University of California, San Francisco
- Investigators
- Prasad Shirvalkar, M.D., Ph.D, Principal investigator, University of California, San FranciscoEdward Chang, M.D., Principal investigator, University of California, San FranciscoPhilip Starr, M.D., Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144972
- Sponsor's protocol ID
- 19-28757
- Other IDs
- UH3NS115631
- Status last verified
- Jul 2026
- First submitted
- 28 Oct 2019
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RC+S
- ClinicalTrials.gov ID
- NCT04144972
- Acronym / sponsor ID
- 19-28757
- Conditions
- Spinal Cord Injuries, Nerve Injury, Pain, Postoperative, Post Herpetic Neuralgia, Complex Regional Pain Syndromes, Post-Stroke Pain
- Keywords
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 24 Oct 2029 (estimated)
- Study completion
- 24 Oct 2030 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A diverse array of chronic pain syndromes are refractory to almost all treatment but involve pathological activity in similar brain regions. This suggests therapeutic potential for deep brain stimulation (DBS) for refractory pain disorders, but despite early promise, long-term efficacy is lacking. Current DBS devices are limited in anatomical reach, targeting only a subset of the distinct brain regions known to be important. Further, DBS therapy is bluntly applied in an "open-loop," continuous fashion without regard to underlying physiology. As a result of these shortcomings, DBS for pain is often ineffective or shows diminished effect over time. Loss of therapeutic effect may be due to nervous system adaptation or a failure of stimulation to accommodate patient- specific dynamics of pain processing. DBS could be significantly improved by seeking individually optimized brain targets or by using neural biomarkers of pain to selectively control stimulation when it is needed ("closed-loop" DBS). Better brain targets would also address the different dimensions of pain such as somatosensory (location, intensity and duration), affective (mood and motivation) and cognitive (attention and memory). The main goal of this study is to test the feasibility of personalized targeting of brain regions that support multiple pain dimensions and to develop new technology for "closed-loop" DBS for pain. The study team will develop data-driven stimulation control algorithms to treat chronic pain using a novel device (Medtronic Summit RC+S or Percept RC) that allows longitudinal intracranial signal recording in an ambulatory setting. By building this technology in an implanted device, chronic pain DBS is tailored to each patient and will advance precision methods for DBS more generally.
Beginning with an inpatient trial period, subjects with various refractory chronic pain syndromes will undergo bilateral surgical implant of temporary electrodes in the thalamus, anterior cingulate, prefrontal cortex, insula and amygdala. These regions have been implicated in the multiple dimensions of pain. The goal of the trial period is to identify candidate biomarkers of pain and optimal stimulation parameters for each individual, and to select subjects who show likelihood to benefit from the trial. A subgroup of 6 such patients will then proceed to chronic implantation of up to 3 "optimal" brain regions for long-term recording and stimulation. The invstigators will first validate biomarkers of low- and high-pain states to define neural signals for pain prediction in individuals (Aim 1). The investigators will then use these pain biomarkers to develop personalized closed-loop algorithms for DBS and test the feasibility of performing closed-loop DBS for chronic pain in weekly blocks (Aim 2). Finally, the investigators will assess efficacy of closed-loop DBS algorithms against sham (placebo) in a double-blinded crossover trial (Aim 3) and measure mechanisms of DBS tolerance. Our main outcome measures will be a combination of pain, mood and functional scores together with quantitative sensory testing. Successful completion of this study would result in the first algorithms to predict real-time fluctuations in chronic pain states and development of a new therapy for currently untreatable diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will participate in the Stage 0, in-clinic evaluation period to assess potential effectiveness of trial. A subset of those enrolled will proceed into the rest of the Stages (1-3).
| Arm | Type | Receives |
|---|---|---|
| Active DBS | Active comparator | Device: Medtronic Summit RC+S or Percept RCChronic brain recordings and stimulation with bilateral implantations in pain-related brain regions. All participants will participate in active DBS, blinded to the participant. |
| Inactive DBS | Sham comparator | Device: Medtronic Summit RC+S or Percept RCNon-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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age 22-80 years old
- Clinical diagnosis of a refractory chronic pain syndrome including
- 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
Key exclusion criteria (14 listed)
- 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.
- History of substance abuse in past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Summit RC+S or Percept RCThe investigators will perform DBS versus sham (randomized) to evaluate efficacy of stimulation for analgesia. Closed-loop DBS will be compared to open-loop DBS in a patient blinded, randomized fashion after initial, efficacy evaluation. | Device | Active DBS, Inactive DBS |
Primary outcome
Feasibility of identifying personalized physiological biomarkers and an optimal stimulation site during the temporary (externalized) trial stage
Time frame: 60 days
Identifying biomarkers in machine learning models that exceed chance and stimulation sites that provide clinically meaningful reductions in chronic pain during a temporary brain stimulation and recording period in hospital
Feasibility of implementing individualized closed-loop DBS for chronic pain
Time frame: 2 years
1 secondary outcome
Safety and Rate of Adverse Events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prasad Shirvalkar, M.D., Ph.D principal investigator
University of California, San Francisco
Edward Chang, M.D. principal investigator
University of California, San Francisco
Philip Starr, M.D., Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Summit RC+S or Percept RC in people with Spinal Cord Injuries and Nerve Injury, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Borror ((415) 353-3494, chronicpain@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of identifying personalized physiological biomarkers and an optimal stimulation site during the temporary (externalized) trial stage (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.