Trigeminal Neuralgia Electrophysiology

NCT05269472 | Recruiting

• 1 other identifier: NSU-2022-30582
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Trigeminal Electrophysiology

Procedure: Trigeminal Electrophysiology

Controls

Interventions

Trigeminal Electrophysiology PROCEDURE

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.

Trigeminal Electrophysiology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Facial pain of unclear origin (i.e. not clearly TGN pain)
• Rhizotomy procedure canceled
• Adults of 18 years or older
• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• David Darrow

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Maple

CONTACT

612-946-1424; maple036@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 8, 2022
• Study Start: April 4, 2022
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

US (1)