Trigeminal Evoked Responses to Improve Rhizotomy

Early Phase 1

Recruiting

• Conditions: Trigeminal Neuralgia; Rhizotomy
• Interventions: Other: TSEP + rhizotomy surgery; Other: TSEPs recording only

• Registration Number: NCT05738096
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-21
• Study Start: 2023-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TGN patients	TSEP + rhizotomy surgery	Patients with TGN who will undergo rhizotomy surgery as the standard of care
Healthy volunteers	TSEPs recording only	Healthy volunteers for whom TSEPS will be recorded in a lab setting

Primary Outcome Measures

Name	Time	Method
Feasibility	3 years	total study procedure completion rate

Secondary Outcome Measures

Name	Time	Method
TSEPS latency between control and TGN patients	1 day	difference in latency between healthy participants and TGN patients
TSEPS peak to peak amplitude within TGN	1 day	difference in measured peak to peak amplitude between normal and TGN side
TSEPS latency within TGN	1 day	difference in measured TSEPS latency between normal and TGN side
TSEPS peak to peak amplitude between control and TGN patients	1 day	difference in measured peak to peak amplitude between healthy participants and TGN patients

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States