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Deep Brain Stimulation

Deep Brain Stimulation 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

Pain that fluctuates over a range of at least 3 points on the NRS

Clinical diagnosis of a refractory chronic pain syndrome including post-traumatic pain syndromes, postsurgical pain syndromes, postherpetic neuralgia, complex regional pain syndrome, atypical facial pain, central pain syndromes, and post-radiation plexopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new way to target multiple brain regions for chronic pain that has potential for better, more enduring analgesia.

Who is the study for?

This trial is for adults aged 22-80 with severe, treatment-resistant chronic pain from conditions like post-traumatic or postsurgical syndromes, nerve injuries, and more. Participants must have had this pain for over two years, failed at least two different pain medications, and not have a correctible cause for the pain. They should be able to understand English and consent to the study. Pregnant women or those with certain medical devices or major health issues can't join.Check my eligibility

What is being tested?

The trial tests a new Deep Brain Stimulation (DBS) device called Medtronic Summit RC+S designed to adaptively target multiple brain regions related to chronic pain. Unlike traditional DBS that stimulates continuously which may lose effect over time, this technology aims for lasting relief by adjusting stimulation as needed.See study design

What are the potential side effects?

Potential side effects of DBS include headache, seizure, confusion, hardware complications like infection or malfunctioning equipment; mood changes such as depression; bleeding in the brain; temporary tingling/pain at implant site; and sleep disturbances.

Eligibility Criteria

Inclusion Criteria

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

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My pain level changes by 3 or more points.

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I have a chronic pain condition that hasn't improved with treatment.

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I have had severe pain for over two years that hasn’t improved with treatment.

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Two surgeons agree surgery can't fix my pain.

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My daily pain level has been over 6 for the last month.

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I am between 22 and 80 years old.

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I understand the study and can give my consent.

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

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

Quantitative Sensory Testing Pain Threshold

Short Form 36 Health Survey

Other outcome measures

Activity Tracker (Fitbit) - Activity (Sleep)

Activity Tracker (Fitbit) - Activity (Steps)

Activity Tracker (Fitbit) - Heartrate

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active DBSActive Control1 Intervention

Chronic brain recordings and stimulation with bilateral implantations in pain-related brain regions. All participants will participate in active DBS, blinded to the participant.

Group II: Inactive DBSPlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,465 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

649,384 Total Patients Enrolled

Edward Chang, M.D.Principal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

4 Total Patients Enrolled

Media Library

Brain Injury Research Study Groups: Active DBS, Inactive DBS

Brain Injury Clinical Trial 2023: Medtronic Summit RC+S Highlights & Side Effects. Trial Name: NCT04144972 — N/A

Medtronic Summit RC+S (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04144972 — N/A

Frequently Asked Questions

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

Would I qualify to be a participant in this research program?

"This clinical research is seeking 10 individuals with complex regional pain syndromes aged between 22 and 80 years old. Qualifications for the trial include a diagnosis of chronic, refractory pain that has been unresponsive to medical treatment for two or more years; examples include post-traumatic root avulsions, nerve crush injuries, postsurgical thoracotomy syndrome, phantom limb pains, postherpetic neuralgia, central multiple sclerosis pain, poststroke discomfort etc."

Answered by AI

Are additional volunteers still sought for this experiment?

"This clinical trial is actively recruiting participants, as verified on clinicaltrials.gov. This medical study was first announced on October 24th 2019 and the most recent update occurred on October 31st 2022."

Answered by AI

How many patients have enrolled in this investigation?

"Affirmative, the clinicaltrials.gov website lists this medical trial as actively recruiting patients. The study was initially posted on October 24th 2019 and recently updated in late October 2022. This particular research is aiming to enlist 10 individuals from a single site."

Answered by AI

Is the age restriction for this research study confined to those above 30 years old?

"The requirements for enrolment in this study stipulate that the participants must be between 22 and 80 years old. There are 278 studies available to those below 18, and 1698 open to seniors aged 65 or more."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

Prasad Shirvalkar, MD, PhD 2019. "Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04144972.

All > Complex Regional Pain Syndrome > Spinal Cord Injury