Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04144972
Status
Recruiting
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Conditions

  • Complex Regional Pain Syndromes
  • Nerve Injury
  • Nerve Root Avulsion
  • Pain, Postoperative
  • Post Herpetic Neuralgia
  • Post Radiation Brain Injury
  • Post Radiation Plexopathy
  • Post-Stroke Pain
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 24, 2019
Status verified
Jul 2025
Primary completion
Oct 24, 2029
Completion
Oct 24, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Visual Analog Score [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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By research site
University of California, San Francisco· San Francisco, CA

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