Recruiting

Closed-Loop DBS

Sponsor:

UCLA

Code:

NCT04144972

Conditions

Spinal Cord Injuries

Nerve Injury

Pain, Postoperative

Post Herpetic Neuralgia

Complex Regional Pain Syndromes

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Medtronic Summit RC+S or Percept RC

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Nerve Injury

Pain, Postoperative

Post Herpetic Neuralgia

Complex Regional Pain Syndromes

Study ID

NCT04144972

Start date

Oct 24, 2019

Status verified date

Jul, 2026

Completion date

Oct 24, 2030

Anticipated

Primary completion date

Oct 24, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Medtronic Summit RC+S or Percept RC

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.

Primary outcome measure

  • Feasibility of identifying personalized physiological biomarkers and an optimal stimulation site during the temporary (externalized) trial stage [ Time Frame: 60 days ]
  • Feasibility of implementing individualized closed-loop DBS for chronic pain [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Chronic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-31.