← Back to Search

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
For Post-Stroke Pain: Stroke of ischemic etiology only. MRI done within one year of the first visit showing a lesion that involves the contralateral brainstem, thalamus or cortex. The lesion will involve cortical-subcortical areas in topography consistent with sensory thalamocortical connections. This will include patients with infarcts in the territory of the middle cerebral artery or those with cavernous malformations. A more recent MRI may be required if the patient's condition changed within the previous year
One year or more of medically refractory severe pain (see below)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I had a stroke caused by a blockage and recent MRI shows damage in specific brain areas.
Select...
I have had severe pain for over a year that medicine hasn't helped.
Select...
I haven't improved with antidepressants, anti-seizure meds, or narcotics.
Select...
I experience severe pain after a stroke, spinal injury, or amputation.
Select...
My daily pain level has been above 5 for the last month.
Select...
I haven't improved after trying an antidepressant, anti-seizure, and narcotic medication.
Select...
I have pain after a stroke, spinal injury, or amputated limb with sensitivity changes.
Select...
I have had severe pain for over a year that hasn’t improved with treatment.
Select...
My daily pain level has been over 5 for the last month.
Select...
My recent MRI shows no issues that would prevent surgery for my spinal cord injury pain.
Select...
My pain medication doses have been stable.
Select...
I have had severe pain for over a year that medicine doesn't help.
Select...
I haven't improved with antidepressants, anti-seizure meds, or narcotics.
Select...
I am 21 years old or older.
Select...
My recent MRI shows no issues that would prevent surgery for my phantom limb pain.
Select...
I understand the study and can give my consent.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analog Score
Secondary outcome measures
Neuropathic Pain Questionnaire
Other outcome measures
Activity Tracker (Fitbit) - Heartrate
Becks Anxiety Inventory
Mental Depression
+2 more

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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham Stimulation
2020
Completed Phase 3
~730

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,335 Previous Clinical Trials
648,527 Total Patients Enrolled
United States Department of DefenseFED
856 Previous Clinical Trials
225,591 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,794 Total Patients Enrolled

Media Library

Medtronic Activa PC+S (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03029884 — N/A
Spinal Cord Injury Research Study Groups: Open-Loop DBS and Closed-Loop DBS, Sham DBS
Spinal Cord Injury Clinical Trial 2023: Medtronic Activa PC+S Highlights & Side Effects. Trial Name: NCT03029884 — N/A
Medtronic Activa PC+S (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03029884 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open opportunities to participate in this research?

"According to information hosted on clinicaltrials.gov, this trial has ceased recruitment efforts; its last update was registered on May 5th 2022. Even though no new participants are being accepted for this study, there are still 896 other studies actively recruiting patients across the country."

Answered by AI

Who else is applying?

What state do they live in?
California
Arizona
What site did they apply to?
University of California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
~1 spots leftby Mar 2025