Adaptive Brain Stimulation Device Tested for Hard-to-Treat Chronic Pain

Trial details

Who runs it

University of California, San Francisco

Trial code

NCT04144972

Record updated

31 July 2026

Original description

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 full original descriptionShow less

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.

Inclusion: 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; 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.

Exclusion: Pregnancy or breast feeding: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure; 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; Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS); 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; 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; 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; 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; Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery; 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; Implantable hardware not compatible with MRI or with the study.

ClinicalTrials.gov NCT04144972