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Recruiting EARLY_Phase 1 NCT05738096

Trigeminal Evoked Responses to Improve Rhizotomy

Trial Parameters

Condition Trigeminal Neuralgia
Sponsor University of Minnesota
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-11-01
Completion 2026-11-01
Interventions
TSEP + rhizotomy surgeryTSEPs recording only

Brief Summary

Trigeminal neuralgia (TGN) is a debilitating pain syndrome where electrical, shock- like jolts of pain affect the face. Trigeminal somatosensory evoked potentials (TSEPs) provide a promising modality for measuring the trigeminal sensory and nociceptive pathway by using peripheral stimulation of the trigeminal nerve (on the skin) and measuring low latency evoked potentials on the scalp (contralateral sensory cortex). While TSEPs have been measured in the past, it is not clear if implementing TSEPs into a routine neurosurgical rhizotomy procedure will be feasible. This is a prospective cohort study examining the feasibility of routinely performing TSEPs during rhizotomies for TGN.

Eligibility 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)

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