Trigeminal Neuralgia Electrophysiology

Trigeminal Evoked Responses to Improve Rhizotomy

The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. The evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (EEG) and at the gasserian ganglion through an FDA-approved recording electrode.

Study Overview

• Status: Recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: Trigeminal Electrophysiology

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Matthew Maple; Phone Number: 612-946-1424; Email: maple036@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Matthew Maple; Phone Number: 612-946-1424; Email: maple036@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults of 18 years or older who are scheduled to undergo percutaneous rhizotomy for facial pain

Description

Inclusion Criteria (TGN):

• Adults of 18 years or older
• Scheduled to undergo percutaneous rhizotomy for facial pain

Exclusion Criteria (TGN):

• Facial pain of unclear origin (i.e. not clearly TGN pain)
• Rhizotomy procedure canceled

Inclusion Criteria (Healthy controls)

• Adults of 18 years or older

Exclusion Criteria (Healthy Controls)

• Diagnosis or history of facial pain such as TMD or TGN
• History of migraine
• History of any functional pain disorder: fibromyalgia, IBS, CRPS
• Recent chronic pain (within last month)
• Unwilling to participate for two hours in lab
• Current acute pain

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls
Trigeminal Electrophysiology	Procedure: Trigeminal Electrophysiology; This study will pilot and test the feasibility of introducing electrophysiology into the routine rhizotomy procedure by including trigeminal somatosensory evoked potentials (TSEPs) and recording from electrodes at the level of the ganglion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the feasibility of measuring trigeminal somatosensory evoked potentials to improve personalized mapping during percutaneous rhizotomy	percentage of consented participants who complete the study	3 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: David Darrow, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2027

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Trigeminal Neuralgia
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Cranial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Trigeminal Neuralgia
• Other Study ID Numbers: NSU-2022-30582

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No