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NCT Number: NCT05738096

Trigeminal Evoked Responses to Improve Rhizotomy

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.

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Key information

Conditions

Trigeminal Neuralgia Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Rhizotomy Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Matthew Maple

CONTACT

[email protected]

612-626-3582

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TSEP + rhizotomy surgery

Other

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

Other

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

Primary outcomes

  1. Feasibility

    Time frame: 3 years

    total study procedure completion rate

Secondary outcomes

  1. TSEPS peak to peak amplitude within TGN

    Time frame: 1 day

    difference in measured peak to peak amplitude between normal and TGN side

  2. TSEPS latency within TGN

    Time frame: 1 day

    difference in measured TSEPS latency between normal and TGN side

  3. TSEPS peak to peak amplitude between control and TGN patients

    Time frame: 1 day

    difference in measured peak to peak amplitude between healthy participants and TGN patients

  4. TSEPS latency between control and TGN patients

    Time frame: 1 day

    difference in latency between healthy participants and TGN patients

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Maple

CONTACT

[email protected]

612-626-3582

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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