Trigeminal Evoked Responses to Improve Rhizotomy

University of Minnesota (UMN)

Status and phase: Enrolling; Early Phase 1

Conditions: Rhizotomy; Trigeminal Neuralgia

Treatments: Other: TSEPs recording only; Other: TSEP + rhizotomy surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05738096

Rhizotomy

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

TGN patients

Experimental group

Description:

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

Treatment:

Other: TSEP + rhizotomy surgery

Healthy volunteers

Active Comparator group

Description:

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

Treatment:

Other: TSEPs recording only