RecruitingEarly Phase 1NCT05738096

Trigeminal Evoked Responses to Improve Rhizotomy


Sponsor

University of Minnesota

Enrollment

30 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying TSEP + rhizotomy surgery and TSEPs recording only for people with rhizotomy and trigeminal neuralgia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTSEP + 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.

OTHERTSEPs 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

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NCT05738096


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