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Deep Brain Stimulation

DBS for Chronic Pain

N/A

Waitlist Available

Led By Edward Chang, M.D.

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One year or more of medically refractory severe pain (see below)

Failure to respond adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic with current stable doses of medications.

Must not have

Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition

Study subjects will be adults with refractory chronic neuropathic pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to provide deep brain stimulation (DBS) for people with chronic pain that has not been relieved by other treatments. DBS involves surgically placing a small device in the brain that sends electrical signals to specific areas. The goal of this trial is to find out whether DBS is more effective when it is turned on only when needed, rather than continuously.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, headache, infection risk from surgery, mood changes due to brain stimulation adjustments and possible interference with other electronic devices in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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I have pain after a stroke, spinal injury, or amputated limb with sensitivity changes.

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I have had severe pain for over a year that hasn’t improved with treatment.

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My daily pain level has been over 5 for the last month.

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My recent MRI shows no issues that would prevent surgery for my spinal cord injury pain.

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

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I am 21 years old or older.

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My recent MRI shows no issues that would prevent surgery for my phantom limb pain.

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I understand the study and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have serious health issues that could make surgery risky.

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I had brain surgery to manage pain in my thalamus.

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I do not have major neurological disorders like epilepsy or neurodegenerative conditions.

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual Analog Score

Secondary study objectives

Neuropathic Pain Questionnaire

Other study objectives

Activity Tracker (Fitbit) - Heartrate

Becks Anxiety Inventory

Mental Depression

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham Stimulation

2020

Completed Phase 3

~770

0 / 17Eligibility criteria met