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Recruiting NCT05269472

Trigeminal Neuralgia Electrophysiology

Observational Trigeminal Neuralgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trigeminal Electrophysiology.
Who it may be relevant to
Registry conditions: Trigeminal Neuralgia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Trigeminal Evoked Responses to Improve Rhizotomy

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Determine the feasibility of measuring trigeminal somatosensory evoked potentials to improve personalized mapping during percutaneous rhizotomy [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT05269472 · NSU-2022-30582

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗