Insula Neuromodulation for Chronic Neuropathic Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Virginia
Must not be taking: Antiplatelets, Anticoagulants
Disqualifiers: Idiopathic pain, Substance abuse, Psychiatric illness, Cardiac issues, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.
Do I need to stop my current medications for the trial?
You need to stay on stable doses of your current pain medications for 30 days before and during the study. However, you must stop taking certain medications that increase bleeding risk, like aspirin or anticoagulants, for a specified period before treatment.
What data supports the effectiveness of the treatment Insula Neuromodulation for Chronic Neuropathic Pain?
Research shows that spinal cord stimulation, a type of neuromodulation, has been effective for chronic neuropathic pain, especially when other treatments fail. Additionally, the posterior-superior insula has been identified as a safe and potentially effective target for neuromodulation in peripheral neuropathic pain.
12345Is insula neuromodulation safe for treating chronic neuropathic pain?
The posterior-superior insula (PSI) has been shown to be a safe target for neuromodulation in peripheral neuropathic pain in humans and animal models.
12367How is insula neuromodulation different from other treatments for chronic neuropathic pain?
Insula neuromodulation is unique because it targets the posterior insula, a specific brain region involved in pain processing, using electrical stimulation to potentially reduce pain without the side effects associated with drugs. This approach is still being studied, but it offers a novel, non-drug option for those who do not respond to traditional treatments.
13589Eligibility Criteria
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.Inclusion Criteria
My pain stops me from working or doing daily activities at home.
My pain has not improved with injections, stimulations, or surgery.
I have been experiencing pain for 6 months or more.
+6 more
Exclusion Criteria
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.
I do not have chronic pain conditions like fibromyalgia or irritable bowel syndrome.
A team of pain doctors and specialists have decided that you are not a good candidate for the study.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Inpatient Stage
Subjects undergo insular brain mapping with acute stimulation and neurophysiological brain monitoring. Electrodes are implanted for stimulation and recording.
Duration not specified
Inpatient stay
Outpatient Stage
Subjects receive chronic deep brain stimulation of the insula in a randomized, sham-stimulation-controlled, double-blinded, cross-over design.
6 months
Regular outpatient visits
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse event reporting and neurological assessments.
6 months post DBS implantation
Participant Groups
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.
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
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.
Neuromodulation is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Neuromodulation Therapy for:
- Chronic Neuropathic Pain
- Epilepsy
- Parkinson's Disease
- Urinary Incontinence
🇺🇸 Approved in United States as Neuromodulation Therapy for:
- Chronic Neuropathic Pain
- Failed Back Surgery Syndrome
- Complex Regional Pain Syndrome
- Epilepsy
- Parkinson's Disease
🇨🇦 Approved in Canada as Neuromodulation Therapy for:
- Chronic Neuropathic Pain
- Epilepsy
- Parkinson's Disease
🇯🇵 Approved in Japan as Neuromodulation Therapy for:
- Chronic Neuropathic Pain
- Parkinson's Disease
🇦🇺 Approved in Australia as Neuromodulation Therapy for:
- Chronic Neuropathic Pain
- Epilepsy
- Parkinson's Disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
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Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor
Boston Scientific CorporationIndustry Sponsor
References
Neuromodulation for Medically Refractory Neuropathic Pain: Spinal Cord Stimulation, Deep Brain Stimulation, Motor Cortex Stimulation, and Posterior Insula Stimulation. [2021]The treatment of neuropathic pain (NP) continues to be controversial as well as an economic health issue and a challenge to health care. Neurosurgery can offer different methods of neuromodulation that may improve patients' condition, including deep brain stimulation (DBS), motor cortex stimulation (MCS), spinal cord stimulation (SCS), and posterior insula stimulation (PIS). There is no consensus of opinion as to the final effects of these procedures, which stimulation parameters to select, the correct timing, or how to select the patients who will best benefit from these procedures.
Neuromodulation. [2021]Spinal cord stimulation is the main neuromodulation therapy for certain chronic neuropathic pain conditions. This article describes neuromodulation and the process of spinal cord stimulation therapy. It also clarifies the suitability of a patient for referral and consideration for spinal cord stimulation.
Non-invasive insular stimulation for peripheral neuropathic pain: Influence of target or symptom? [2022]The posterior-superior insula (PSI) has been shown to be a safe and potentially effective target for neuromodulation in peripheral neuropathic pain (PNP) in humans and animal models. However, it remains unknown whether there is a measurable responder profile to PSI stimulation. Two factors were hypothesized to influence the response of repetitive transcranial magnetic stimulation (rTMS) of the PSI: differences in rTMS target (discrete subregions of the PSI) or PNP phenotype.
[Spinal cord stimulation in chronic neuropathic pain]. [2016]Seventeen years' experience of spinal cord stimulation in the treatment of chronic pain has shown it to be effective only in the case of neuropathic pain--in particular, pain due to lesions in peripheral nerves or posterior roots. In such cases, pharmacological treatment is often unsuccessful, and transcutaneous electrical nerve stimulation is only useful in certain cases. In a retrospective study of 84 patients followed for up to 16 years, 56 patients were still using their stimulators and reported continued pain relief. The majority suffered from peripheral neuralgia due to trauma or surgery and 72 per cent in that group enjoyed satisfactory relief. Trial stimulation via a temporary extension lead for at least 4-5 days is a prerequisite of good long-term results. It is concluded that spinal cord stimulation is an indispensable tool for treating chronic neuropathic pain, and it merits to be used more frequently.
A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study. [2018]Peripheral neuromodulation is often used as chronic neuropathic pain treatment. Percutaneous electrical nerve stimulation (PENS) is generally utilized with several probes at the same time and repeated treatments.
Some Non-FDA Approved Uses for Neuromodulation: A Review of the Evidence. [2018]Neuromodulation, including spinal cord stimulation and peripheral nerve field stimulation, has been used with success in treating several painful conditions. The FDA approved the use of neuromodulation for a few indications. We review evidence for neuromodulation in treating some important painful conditions that are not currently FDA approved.
Neuromodulation for chronic pain. [2021]Neuromodulation is an expanding area of pain medicine that incorporates an array of non-invasive, minimally invasive, and surgical electrical therapies. In this Series paper, we focus on spinal cord stimulation (SCS) therapies discussed within the framework of other invasive, minimally invasive, and non-invasive neuromodulation therapies. These therapies include deep brain and motor cortex stimulation, peripheral nerve stimulation, and the non-invasive treatments of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, and transcutaneous electrical nerve stimulation. SCS methods with electrical variables that differ from traditional SCS have been approved. Although methods devoid of paraesthesias (eg, high frequency) should theoretically allow for placebo-controlled trials, few have been done. There is low-to-moderate quality evidence that SCS is superior to reoperation or conventional medical management for failed back surgery syndrome, and conflicting evidence as to the superiority of traditional SCS over sham stimulation or between different SCS modalities. Peripheral nerve stimulation technologies have also undergone rapid development and become less invasive, including many that are placed percutaneously. There is low-to-moderate quality evidence that peripheral nerve stimulation is effective for neuropathic pain in an extremity, low quality evidence that it is effective for back pain with or without leg pain, and conflicting evidence that it can prevent migraines. In the USA and many areas in Europe, deep brain and motor cortex stimulation are not approved for chronic pain, but are used off-label for refractory cases. Overall, there is mixed evidence supporting brain stimulation, with most sham-controlled trials yielding negative findings. Regarding non-invasive modalities, there is moderate quality evidence that repetitive transcranial magnetic stimulation does not provide meaningful benefit for chronic pain in general, but conflicting evidence regarding pain relief for neuropathic pain and headaches. For transcranial direct current stimulation, there is low-quality evidence supporting its benefit for chronic pain, but conflicting evidence regarding a small treatment effect for neuropathic pain and headaches. For transcutaneous electrical nerve stimulation, there is low-quality evidence that it is superior to sham or no treatment for neuropathic pain, but conflicting evidence for non-neuropathic pain. Future research should focus on better evaluating the short-term and long-term effectiveness of all neuromodulation modalities and whether they decrease health-care use, and on refining selection criteria and treatment variables.
Cortical Neurostimulation and N-Methyl-D-Aspartate Glutamatergic Receptor Activation in the Dysgranular Layer of the Posterior Insular Cortex Modulate Chronic Neuropathic Pain. [2023]The dysgranula parts of the posterior insular cortex (PIC) stimulation (PICS) has been investigated as a new putative cortical target for nonpharmacologic therapies in patients with chronic and neuropathic pain (NP). This work investigates the neural bases of insula neurostimulation-induced antinociception and glutamatergic neurochemical mechanisms recruited by the PICS in animals with neuropathy.
Insular cortex stimulation alleviates neuropathic pain via ERK phosphorylation in neurons. [2023]The clinical use of brain stimulation is attractive for patients who have side effects or tolerance. However, studies on insular cortex (IC) stimulation are lacking in neuropathic pain. The present study aimed to investigate the effects of IC stimulation (ICS) on neuropathic pain and to determine how ICS modulates pain.