Using trigeminal evoked responses to enhance rhizotomy for facial pain relief
Trigeminal Evoked Responses to Improve Rhizotomy
This study is testing if measuring brain responses during surgery can help improve pain relief for adults with trigeminal neuralgia who are having rhizotomy.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05738096 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of incorporating trigeminal somatosensory evoked potentials (TSEPs) into routine neurosurgical rhizotomy procedures for patients suffering from trigeminal neuralgia. By stimulating the trigeminal nerve and measuring the resulting electrical responses in the brain, researchers aim to improve the accuracy and effectiveness of the rhizotomy surgery. The study will involve adults scheduled for this procedure, assessing whether TSEPs can be reliably recorded during surgery. The goal is to enhance surgical outcomes for patients with debilitating facial pain.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to undergo percutaneous rhizotomy for facial pain due to trigeminal neuralgia.
Not a fit: Patients with facial pain of unclear origin or those whose rhizotomy procedure has been canceled will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective pain relief for patients suffering from trigeminal neuralgia.
How similar studies have performed: While TSEPs have been previously measured, this specific application in routine rhizotomy procedures is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults of 18 years or older * Scheduled to undergo percutaneous rhizotomy for facial pain Exclusion Criteria: * For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled * For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: David P Darrow, MD — University of Minnesota
- Study coordinator: Matthew Maple
- Email: maple036@umn.edu
- Phone: 612-626-3582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.