What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS), particularly adaptive and multi-region targeting, is a promising treatment for brain injuries and chronic pain. Common side effects of DBS include infection at the implantation site, bleeding in the brain, and hardware complications such as lead migration or breakage. Patients may also experience mood changes, cognitive disturbances, and seizures. These side effects are generally rare but can be serious, necessitating careful monitoring and management by healthcare providers.

What prior FDA approvals exist?

There are no specific FDA approvals for adaptive, multi-region targeting deep brain stimulation (DBS) for brain injury. However, traditional DBS has been approved for other neurological conditions such as Parkinson's disease and treatment-resistant depression. These approvals highlight the potential of neuromodulation therapies in managing complex neurological disorders, suggesting a promising future for adaptive DBS in brain injury treatment.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for brain injury patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving aphasia and poststroke rehabilitation by enhancing neuroplasticity. 2) Transcranial Magnetic Stimulation (TMS), which has been effective in reducing headache days in migraine patients and may offer benefits for brain injury rehabilitation. 3) Spinal Cord Stimulation (SCS), particularly high-frequency and burst SCS, which has been effective in treating chronic pain and may have applications in managing pain associated with brain injuries.

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Deep Brain Stimulation

Deep Brain Stimulation for Chronic Pain

N/A

Recruiting

Led By Philip Starr, M.D., Ph.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

Must not have

Previous cranial ablative surgery

Inability to stop anticoagulation or platelet anti-aggregation therapy for surgery and recovery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial tests a new type of brain stimulation device for people with chronic pain that doesn't respond to other treatments. The device sends electrical signals to different parts of the brain and adjusts these signals based on real-time pain levels. The goal is to provide better and longer-lasting pain relief.

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.

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.

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.

Exclusion Criteria

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

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I have had brain surgery to remove a tumor.

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I cannot stop my blood thinners for surgery and recovery.

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I had deep brain stimulation surgery with a system not compatible with RC+S.

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I need treatments like diathermy, ECT, or TMS.

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My MRI shows signs that suggest a different diagnosis or reasons I can't have surgery.

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I have serious health issues that make surgery risky.

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

Quantitative Sensory Testing Pain Threshold

Short Form 36 Health Survey

Other study objectives

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 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Deep Brain Stimulation (DBS) works by delivering electrical impulses to specific brain regions to modulate neural activity, which can help restore function in damaged neural circuits. This is particularly important for brain injury patients as it can potentially improve motor and cognitive functions that are impaired due to injury. Other neuromodulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), also aim to modulate brain activity but do so non-invasively. These treatments can help in reducing symptoms like spasticity, dystonia, and tremors by altering the excitability of neural networks. The adaptive, multi-region targeting approach in DBS is significant as it allows for more precise and effective modulation of brain activity, potentially leading to better and more enduring outcomes for patients with treatment-resistant conditions.

Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Why Does Brain Trauma Research Fail?