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Neuromodulation Device
Insula Neuromodulation for Chronic Neuropathic Pain
Phase 1 & 2
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months post dbs stimulation, 3 months post sham stimulation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My pain has not improved with injections, stimulations, or surgery.
Select...
My pain stops me from working or doing daily activities at home.
Select...
My pain hasn't improved despite trying three different pain relief medications, including opioids.
Select...
I have been experiencing severe pain, averaging 5 or more out of 10, for the last two months.
Select...
I am between 18 and 75 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,019 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
933,058 Total Patients Enrolled
5 Trials studying Neuropathic Pain
138 Patients Enrolled for Neuropathic Pain
Jeff Elias, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
7 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My pain is mostly caused by nerve damage.I have chronic pain from a specific injury to my nerves or brain.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.People with serious mental health conditions that could affect the study's results, such as schizophrenia, bipolar disorder, recent suicide attempts, or recent hospitalization for psychiatric treatment, will not be able to participate.I have been experiencing severe pain, averaging 5 or more out of 10, for the last two months.I do not have severe heart problems or conditions that prevent MRI scans.My pain hasn't improved despite trying three different pain relief medications, including opioids.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: DBS of the insula
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study include elderly participants?
"In order to participate in this trial, patients must be aged between 18 and 75. There are currently 39 other trials underway for individuals under the age of 18 and 498 for those over 65."
Answered by AI
How many people are eligible to participate in this clinical trial?
"That is correct. The clinicaltrials.gov website has the latest information on this trial, which was originally posted on November 1st, 20202 and last updated on October 31st, 20202. They are looking for a total of 12 people to participate at 1 location."
Answered by AI
How do I qualify to enroll in this research project?
"This clinical trial is looking for 12 patients, aged 18 to 75, who suffer from chronic pain. In order to be eligible for the study, patients must meet the following criteria: -Chronic pain with a duration of ≥6 months- Men and women between 18 and 75 years old- Willing and able to give consent and attend all study visits-NPRS score of ≥ 5 out of 10 at current visit AND similar level of pain for at least past 2 months (severe)-Disabling pain that has resulted in an inability to work or perform ADLs-Medication resistant;"
Answered by AI
Are participants still being accepted for this experiment?
"That is correct. The listing on clinicaltrials.gov says that the trial is still open and looking for new patients. According to the posting, which was last edited on October 31st, 2022, they are aiming to enroll 12 people total from 1 location."
Answered by AI
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