DBS for Chronic Pain

Recruiting in Palo Alto (17 mi)

Overseen byPrasad Shirvalkar, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Edward Chang, M.D.

Principal Investigator

University of California, San Francisco

Prasad Shirvalkar, M.D., Ph.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Adults over 21 with severe chronic pain from conditions like post-stroke pain, spinal cord injury, or phantom limb pain that hasn't improved after trying several medications. They must be able to speak/read English and women should use contraception. Excluded are those with incompatible implants, cognitive impairments, recent substance abuse, major medical issues increasing surgery risk, or who can't stop certain blood thinners.

Inclusion Criteria

I have had severe pain for over a year that medicine hasn't helped.

I haven't improved with antidepressants, anti-seizure meds, or narcotics.

I experience severe pain after a stroke, spinal injury, or amputation.

See 12 more

Exclusion Criteria

I cannot stop taking blood thinners for surgery.

I need special treatments like ECT or TMS for a long-term condition.

I am an adult with chronic nerve pain that hasn't improved with treatment.

See 20 more

Treatment Details

Interventions

Medtronic Activa PC+S (Deep Brain Stimulation)

Trial OverviewThe trial is testing a new type of brain stimulation device for chronic pain relief. It compares continuous 'open-loop' DBS (current standard), no stimulation ('sham'), and 'closed-loop' DBS which activates only when the brain signals high pain levels. The goal is to see if this personalized approach provides better long-term relief.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Sham DBSExperimental Treatment1 Intervention

Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in sham, open-loop and closed-loop DBS, blinded to the participant. Open Loop involves tonic stimulation of ACC of OFC brain region. During closed-loop DBS sessions, stimulation will be delivered in response to identified personalized, brain biomarkers of chronic pain.Sham involves no active stimulation - brain recordings will remain active with no active stimulation. Because more than 6 sequences were used, only 1 "Arm/Group" is defined.

Group II: Open-Loop DBS and Closed-Loop DBSExperimental Treatment2 Interventions