Recruiting
Early Phase 1

Trigeminal Evoked Responses

Sponsor:

University of Minnesota

Code:

NCT05738096

Conditions

Trigeminal Neuralgia

Rhizotomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

TSEP + rhizotomy surgery

TSEPs recording only

Study Details

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.

Conditions

Trigeminal Neuralgia

Rhizotomy

Study ID

NCT05738096

Start date

Nov 1, 2023

Status verified date

Nov, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: TGN patients

Patients with TGN who will undergo rhizotomy surgery as the standard of care

active comparator: Healthy volunteers

Healthy volunteers for whom TSEPS will be recorded in a lab setting

Interventions

TSEP + rhizotomy surgery

TGN patients recruited for this study will already be undergoing percutaneous rhizotomy surgery. TSEPs will be measured at baseline prior to surgery. During the rhizotomy procedure, an electrode or balloon is placed through a metal sheath to then damage the nerve. A stylet is introduced to clear tissue from the sheath in preparation for the electrode or balloon. Prior to the final insertion of the RF electrode where the gasserian ganglion will be damaged, we will place a standard stereotactic EEG electrode (SEEG). Following damaging the nerve (clinical procedure), we will record again to measure differences in the TSEPs following cell body damage. The Neuralynx system will be used to record the potentials at 40 KHz.

TSEPs recording only

TSEPS will also be recorded from healthy controls in a lab setting; all procedures for the healthy controls will be non-invasive.

Primary outcome measure

  • Feasibility [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Matthew Maple

612-626-3582maple036@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Matthew Maple

612-626-3582maple036@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-11-26.