Actively Recruiting
Insula Neuromodulation for Chronic Neuropathic Pain
Led by University of Virginia · Updated on 2024-12-10
12
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will comprehensively investigate the insula as a brain target for neuromodulation to treat chronic neuropathic pain.
CONDITIONS
Official Title
Insula Neuromodulation for Chronic Neuropathic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 80 years, inclusive
- Able and willing to give consent and attend all study visits
- Chronic pain lasting 6 months or more
- Severe pain with average score of 5 or higher on a 10-point scale at current visit and similar pain level for at least 2 months
- Pain disabling and causing inability to work or perform daily activities
- Pain resistant to at least 3 pain medications including at least one opioid, with inadequate relief
- Pain resistant to other treatments like injections, spinal neuromodulation, or neurosurgical surgery
- Neuropathic or mainly neuropathic pain caused by specific injury to peripheral or central nervous system
- Insula visible on MRI for targeting electrode placement
- Able to communicate sensations during stimulation testing
- Stable pain medication doses for 30 days before and during the study
- Inclusion and exclusion criteria confirmed by principal investigator and pain psychologist
You will not qualify if you...
- Idiopathic pain syndromes such as fibromyalgia, temporomandibular joint disorders, irritable bowel syndrome, chronic headaches, interstitial cystitis, chronic pelvic pain, or whiplash-associated disorders
- Poor candidates due to unreliable information or substance abuse behaviors within past 12 months
- Active psychiatric illness including major disorders, recent suicide attempts or ideation, recent psychiatric hospitalization, history of psychosis, or certain treatments for depression
- Unstable cardiac conditions including recent heart attack, heart failure with low ejection fraction, arrhythmias not controlled
- Severe hypertension with diastolic blood pressure over 100 on medication
- MRI contraindications such as incompatible implants or size limitations
- Use of medications increasing bleeding risk including recent aspirin, antiplatelet, or anticoagulant therapy
- Unable or unwilling to tolerate prolonged hospitalization with video EEG monitoring
- Participation in another chronic pain trial within last 30 days
- Bleeding risk due to coagulopathy or abnormal coagulation labs
- Brain tumors or significant intracranial masses
- History of seizures
- Any illness preventing study participation as judged by investigator
- Pregnancy or breastfeeding
- Allergy to opioid medications preventing PET imaging
- Legal incapacity or limited legal capacity
- Existing deep brain stimulation implant
- Recent hemorrhagic stroke or cerebrovascular event with incomplete recovery within past year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
J
Judy Beenhakker
CONTACT
Z
Zak Sturgill
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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