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NCT05269472 Clinical Trial

Trigeminal Neuralgia Electrophysiology

Trigeminal Neuralgia Clinical Trial

Official title:
Trigeminal Evoked Responses to Improve Rhizotomy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05269472
Other study ID # NSU-2022-30582
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 4, 2022
Est. completion date April 7, 2025

Study information
Verified date April 2024
Source University of Minnesota
Contact Danielle Carlson
Phone 612-946-1424
Email carl1492@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date April 7, 2025
Est. primary completion date April 7, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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