Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

NCT04144972 | Recruiting DMC FDA Device

• 2 other identifiers: 19-28757UH3NS115631
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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; Post-Stroke Pain; Post Radiation Brain Injury; Post Radiation Plexopathy; Nerve Root Avulsion

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Score

  Visual Analog Score is indicated by the patient by marking a 10 cm line as they rate their pain intensity from 0 to 100 in mm.

  2 years

Secondary Outcomes (3)

• Short Form 36 Health Survey

  2 years

• Quantitative Sensory Testing Pain Threshold

  2 years

• Neuropathic Pain Questionnaire

  2 years

Other Outcomes (7)

• Becks Depression Inventory

  2 years

• Becks Anxiety Inventory

  2 years

• NIH PROMIS toolbox (Patient Impression)

  2 years

Study Arms (2)

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.

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.

Device: Medtronic Summit RC+S or Percept RC

Interventions

Medtronic Summit RC+S or Percept RC DEVICE

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.

Active DBS; Inactive DBS

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• History of substance abuse in past 3 years
• Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Pain, Postoperative; Neuralgia, Postherpetic; Complex Regional Pain Syndromes; Radiculopathy; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autonomic Nervous System Diseases

Study Officials

• Prasad Shirvalkar, M.D., Ph.D

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Edward Chang, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Philip Starr, M.D., Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Borror

CONTACT

‪(415) 353-3494; chronicpain@ucsf.edu

Prasad Shirvalkar, M.D., Ph.D

CONTACT

‪(415) 691-7587‬; Prasad.Shirvalkar@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: There will be assigned active intervention and non-active intervention periods for each patient throughout Phase 2 and 3 of the study. The participant will not know if he/she is in the active or non-active period of the phase.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Model Details: 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).

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 24, 2019
• Primary Completion (Estimated): October 24, 2029
• Study Completion (Estimated): October 24, 2030
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)