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RECRUITING
NCT05738096
EARLY_PHASE1

Trigeminal Evoked Responses to Improve Rhizotomy

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-11-01

Completion Date

2026-11-01

Last Updated

2025-11-26

Healthy Volunteers

Yes

Interventions

OTHER

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.

OTHER

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.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States