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Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

NCT04144972 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-07-08

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

  • Prasad Shirvalkar, M.D., Ph.D · University of California, San Francisco

  • Edward Chang, M.D. · University of California, San Francisco

  • Philip Starr, M.D., Ph.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-24
Primary Completion
2029-10-24
Completion
2030-10-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04144972 on ClinicalTrials.gov