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TSEP + Rhizotomy for Trigeminal Neuralgia

Phase < 1
Recruiting
Led By David P Darrow, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled to undergo percutaneous rhizotomy for facial pain
Be older than 18 years old
Must not have
For Healthy control: History of any functional pain disorder: fibromyalgia, IBS, CRPS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at if it's possible to use a nerve test to measure pain related to Trigeminal Neuralgia (TGN), a debilitating face pain syndrome.

Who is the study for?
This trial is for adults over 18 who are scheduled for rhizotomy surgery to treat severe facial pain known as trigeminal neuralgia. It's not suitable for individuals with a history of migraines, functional pain disorders like fibromyalgia or IBS, recent chronic pain, unclear facial pain origins, or those whose procedure is canceled.
What is being tested?
The study tests if measuring brain responses (TSEPs) during rhizotomy surgery can help in treating trigeminal neuralgia. Participants will either have TSEP measurements taken alongside their surgery or just the standard surgical procedure without TSEP recording.
What are the potential side effects?
Since this trial involves a surgical procedure (rhizotomy), potential side effects may include discomfort at the stimulation site on the face, infection risk from surgery, and typical post-surgical issues such as swelling or bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a procedure to treat facial pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of conditions like fibromyalgia, IBS, or CRPS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility
Secondary study objectives
TSEPS latency between control and TGN patients
TSEPS latency within TGN
TSEPS peak to peak amplitude between control and TGN patients
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TGN patientsExperimental Treatment1 Intervention
Patients with TGN who will undergo rhizotomy surgery as the standard of care
Group II: Healthy volunteersActive Control1 Intervention
Healthy volunteers for whom TSEPS will be recorded in a lab setting

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,928 Total Patients Enrolled
2 Trials studying Trigeminal Neuralgia
35 Patients Enrolled for Trigeminal Neuralgia
David P Darrow, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

TSEP + rhizotomy surgery Clinical Trial Eligibility Overview. Trial Name: NCT05738096 — Phase < 1
Trigeminal Neuralgia Research Study Groups: TGN patients, Healthy volunteers
Trigeminal Neuralgia Clinical Trial 2023: TSEP + rhizotomy surgery Highlights & Side Effects. Trial Name: NCT05738096 — Phase < 1
TSEP + rhizotomy surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738096 — Phase < 1
~18 spots leftby Nov 2026
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