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Neuromodulation Device

Insula Neuromodulation for Chronic Neuropathic Pain

N/A

Recruiting

Led By Jeff Elias, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

The pain is treatment-resistant and cannot be treated or has failed procedures including interventional therapies with injections, spinal neuromodulation with medication infusion or stimulation, and neurosurgical ablation surgery

The pain is disabling and has resulted in an inability to work or perform ADLs in the home

Must not have

On medications that increases the bleeding risk, based on the published guidelines41 which are currently recognized by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine and the North American Neuromodulation Society: Aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abiciximab) for the last 7 days prior to treatment, Oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours, Intravenous or subcutaneous heparin-derived compounds for the last 48 hours, Individuals who are not able or willing to tolerate prolonged hospitalization with continuous video EEG monitoring, Subjects participating or have participated in another clinical trial to investigate or treat chronic pain in the last 30 days, Subjects with risk factors for intraoperative or postoperative bleeding from a documented coagulopathy or if their serum coagulation studies (platelet count, PT, PTT, and INR) exceed the institutional laboratory limits, Subjects with brain tumors or any significant intracranial mass, Subjects with a history of seizure, Any illness that in the investigator's opinion preclude participation in this study, Pregnancy or lactation, Subjects with a true allergy to opioid medications which would preclude PET imaging, Legal incapacity or limited legal capacity, Subjects with a deep brain stimulation implant, History of hemorrhagic stroke or cerebrovascular event within the past year of treatment exhibiting incomplete resolution

Idiopathic pain syndromes will be excluded. Examples include: Fibromyalgia syndrome, temporomandibular joint disorders, irritable bowel syndrome, chronic headaches, interstitial cystitis, chronic pelvic pain, whiplash-associated disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months post dbs stimulation, 3 months post sham stimulation

Summary

This trialwill look at using a brain target to stop chronic pain.

Who is the study for?

This trial is for adults aged 18-75 with chronic neuropathic pain lasting over 6 months, severe enough to disrupt daily life and work. Participants must have tried at least three different pain medications, including opioids, without relief and not responded to other treatments like injections or surgery. They should be able to attend all visits, have stable medication doses for 30 days prior, and their insula region must be visible on MRI.

What is being tested?

The study tests neuromodulation targeting the insula in the brain as a potential treatment for chronic neuropathic pain. It involves participants who've had specific injuries causing this type of pain such as post-stroke or spinal cord injury.

What are the potential side effects?

While not explicitly listed in the provided information, neuromodulation may cause discomfort at the stimulation site, headache, dizziness or tingling sensations during procedures. There could also be risks associated with surgical implantation if involved.

Eligibility Criteria

Inclusion Criteria

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

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My pain has not improved with injections, stimulations, or surgery.

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My pain stops me from working or doing daily activities at home.

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My pain hasn't improved despite trying three different pain relief medications, including opioids.

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I have been experiencing severe pain, averaging 5 or more out of 10, for the last two months.

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I am between 18 and 75 years old.

Exclusion Criteria

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

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Criterion: You are currently taking certain medications that increase the risk of bleeding, or have specific medical conditions such as brain tumors, seizure history, or recent stroke, which would prevent you from participating in the study.

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I do not have chronic pain conditions like fibromyalgia or irritable bowel syndrome.

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I do not have severe heart problems or conditions that prevent MRI scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months post dbs stimulation, 3 months post sham stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months post dbs stimulation, 3 months post sham stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months post dbs stimulation, 3 months post sham stimulation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events

Pain intensity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: DBS of the insulaActive Control1 Intervention

Subjects who respond favorably to test/trial stimulation of the insula will be implanted with DBS devices. In an outpatient clinical trial, each subject will receive 3 months of active stimulation and 3 months of sham stimulation. The assignment for stimulation will be randomized and blinded to the subject and to the outcome assessors.

Group II: ControlPlacebo Group1 Intervention

0 / 8Eligibility criteria met