Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain

Summary

Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.

Conditions

• Chronic Pain
• Post Stroke Pain
• Phantom Limb Pain
• Spinal Cord Injuries

Interventions

DEVICE

Open-Loop DBS

Conventional brain stimulation that is tonically providing stimulation, without feedback

DEVICE

Sham Stimulation

No Active Stimulation

DEVICE

Closed-Loop DBS

Feedback enabled brain stimulation, where stimulation is provided on demand in response to pain biomarkers.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Prasad Shirvalkar, MD, PhD

  lead OTHER

Principal Investigators

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

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-28

Primary Completion

2023-09-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations