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TSEP + Rhizotomy for Trigeminal Neuralgia

Q: Are there still opportunities for individuals to enroll in this research endeavor?

<p>It appears that, according to the clinicaltrials.gov data, this trial has concluded its recruitment process and is no longer actively seeking candidates. This study was initially posted on March 1st 2023 and received a final update February 17th of the same year. Nevertheless, 141 other medical trials are currently open for participation at present time.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility

Secondary outcome measures

TSEPS latency between control and TGN patients

TSEPS latency within TGN

TSEPS peak to peak amplitude between control and TGN patients

+1 more

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,945 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for individuals to enroll in this research endeavor?

"It appears that, according to the clinicaltrials.gov data, this trial has concluded its recruitment process and is no longer actively seeking candidates. This study was initially posted on March 1st 2023 and received a final update February 17th of the same year. Nevertheless, 141 other medical trials are currently open for participation at present time."

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