Trigeminal Evoked Responses to Improve Rhizotomy

NCT05738096 | Recruiting Early Phase 1

• 1 other identifier: Rhizotomy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

  total study procedure completion rate

  3 years

Secondary Outcomes (4)

• TSEPS peak to peak amplitude within TGN

  1 day

• TSEPS latency within TGN

  1 day

• TSEPS peak to peak amplitude between control and TGN patients

  1 day

• TSEPS latency between control and TGN patients

  1 day

Study Arms (2)

TGN patients

EXPERIMENTAL

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

Other: TSEP + rhizotomy surgery

Healthy volunteers

ACTIVE COMPARATOR

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

Other: TSEPs recording only

Interventions

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.

TGN patients

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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of 18 years or older
• Scheduled to undergo percutaneous rhizotomy for facial pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• David P Darrow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Maple

CONTACT

612-626-3582; maple036@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 21, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)