TSEP + Rhizotomy for Trigeminal Neuralgia

Overseen By Matthew Maple

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Facial pain, Migraine, Fibromyalgia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure facial nerve activity during rhizotomy, a surgery for treating trigeminal neuralgia (TGN), a condition causing severe facial pain. By using Trigeminal Somatosensory Evoked Potentials (TSEPs), researchers aim to better understand and potentially enhance this surgery. The trial includes two groups: TGN patients undergoing rhizotomy and healthy volunteers having TSEPs recorded in a lab. Those scheduled for rhizotomy due to TGN might be suitable for the trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that TSEPs with rhizotomy is safe for trigeminal neuralgia patients?

Research is investigating whether TSEPs (trigeminal somatosensory evoked potentials) can be safely used during rhizotomy surgery for trigeminal neuralgia (TGN), a painful facial condition. This surgery is already a common treatment for TGN.

The current study focuses on adding TSEPs to the surgery. As an early-phase trial, it primarily assesses the safety and feasibility of this combination, meaning safety information remains preliminary. However, rhizotomy surgery itself is a well-established method and is generally considered safe when performed by experienced professionals.

Since this study is in its early phase, the safety of TSEPs is still under evaluation. Potential participants can expect careful monitoring to ensure safety throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for trigeminal neuralgia, like medications or traditional rhizotomy surgery, focus on alleviating pain by disrupting nerve signals. But the combination of TSEP (Transcranial Electrical Stimulation Evoked Potentials) with rhizotomy offers a new approach by potentially enhancing the precision of nerve targeting during surgery. Researchers are excited about this because it could lead to more effective and longer-lasting pain relief with fewer side effects. By integrating TSEP, there might be a way to better tailor the surgery to each patient's unique nerve patterns, which could revolutionize treatment outcomes for those suffering from this debilitating condition.

What evidence suggests that TSEP + rhizotomy surgery could be effective for trigeminal neuralgia?

Research shows that rhizotomy surgery is a well-established treatment for trigeminal neuralgia (TGN), reducing facial pain by targeting specific nerves. Studies indicate that rhizotomy can be particularly effective for patients who haven't found relief with medication. In this trial, some participants with TGN will undergo rhizotomy surgery as part of the standard of care. Meanwhile, researchers are studying trigeminal somatosensory evoked potentials (TSEPs) to measure brain responses during surgery, which could improve results. TSEPs involve stimulating the trigeminal nerve and recording the brain's reactions. Although TSEPs are a new concept, they might help make the surgery more precise. Healthy volunteers in this trial will have TSEPs recorded in a lab setting. ^{1 2 4 5 6}

Who Is on the Research Team?

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for a procedure to treat facial pain.

Exclusion Criteria

I have never had facial pain like TMD or TGN.

I have facial pain that hasn't been diagnosed as trigeminal neuralgia, or my rhizotomy was canceled.

I have experienced chronic pain in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo rhizotomy surgery with TSEPs measurement for TGN patients and TSEPs recording in a lab setting for healthy volunteers

1 day

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TSEP + rhizotomy surgery
• TSEPs recording only

Trial Overview 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.

How Is the Trial Designed?

Group I: TGN patients Experimental Treatment 1 Intervention

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

Group II: Healthy volunteers Active Control 1 Intervention

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

TSEP + rhizotomy surgery is already approved in United States, European Union for the following indications:

Approved in United States as Rhizotomy for:

• Trigeminal Neuralgia

Approved in European Union as Rhizotomy for:

• Trigeminal Neuralgia

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 1000 patients with classic trigeminal neuralgia, 90% initially responded to medical therapy, but 75% did not achieve long-term relief, leading to surgical interventions for many.

Both percutaneous stereotaxic rhizotomy (PSR) and posterior fossa exploration (PFE) showed similar effectiveness in treating trigeminal neuralgia, with PSR being preferred due to its less invasive nature and easier repeatability, achieving excellent outcomes in 61% of patients after 6 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

a 10-year experience in the treatment of trigeminal neuralgia. Comparison of percutaneous stereotaxic rhizotomy and posterior fossa exploration. van Loveren, H., Tew, JM., Keller, JT., et al.[2022]

The novel peroral trigeminal rhizotomy method using a 3D-printed patient-specific guidance tool was successfully performed on 18 patients, with all procedures completed on the first attempt and an average surgery time of just 19 minutes.

The procedure resulted in significant pain relief, with 8 patients achieving complete analgesia and 6 experiencing pain relief, while only 4 patients had persistent trigeminal pain after follow-up of up to 20 months, indicating both efficacy and safety of the technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peroral Trigeminal Rhizotomy Using a Novel 3-Dimensional Printed Patient-Specific Guidance Tool. Oertel, MF., Sarnthein, J., Regli, L., et al.[2022]

Trigeminal somatosensory-evoked potentials (TSEPs) provide a non-invasive and objective way to assess neuronal function in patients experiencing oro-facial sensory impairment after procedures like third molar extractions and maxillo-facial trauma.

The increasing popularity of TSEP recording in the last decade highlights its potential clinical applications in oral and maxillo-facial surgery, making it a valuable tool for evaluating sensory nerve function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigeminal somatosensory evoked potentials. A review of the literature as applicable to oral dysaesthesias. Bennett, AJ., Wastell, DG., Barker, GR., et al.[2019]

Descending trigeminal tractotomy effectively relieved pain in 7 patients with medically untreatable trigeminal neuralgia who did not respond to previous surgical treatments, with pain cessation observed immediately after surgery.

All patients remained pain-free during follow-up periods ranging from 9 months to 15 years, indicating the long-term efficacy of this surgical intervention for this challenging condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descending trigeminal tractotomy for trigeminal neuralgia after surgical failure. Morita, M., Hosobuchi, Y.[2018]

In a study of 99 patients undergoing carotid endarterectomy, stable intra-operative trigeminal scalp-induced somatosensory-evoked potentials (T-SSEP) were reliably recorded, demonstrating a mean latency of 12.4 ms and an amplitude of 5.7 μV.

The findings indicate that T-SSEP recordings are not affected by muscle activity, confirming their reliability and suggesting they originate from non-muscular sources, which is important for monitoring during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recordings of long-latency trigeminal somatosensory-evoked potentials in patients under general anaesthesia. Malcharek, MJ., Landgraf, J., Hennig, G., et al.[2011]

In a study involving 43 patients with trigeminal neuralgia, atypical facial pain, and cancer pain, trigeminal somatosensory evoked potentials (TSEP) were analyzed as a potential diagnostic tool for pain classification.

The results showed that changes in TSEP latency periods correlated with patients' pain sensations, but no specific pathological peaks were identified, indicating that TSEP results should be interpreted alongside clinical symptoms rather than as standalone diagnostic indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Possibilities of trigeminal somatosensory evoked potentials in diagnosing neuralgiform facial pain]. Krischek-Bremerich, P., Bremerich, A.[2006]

In a study of 139 patients undergoing retrogasserian glycerol rhizotomy for trigeminal neuralgia, technical difficulties were encountered in 47.3% of cases, leading to interruptions in 8.1% of procedures due to serious complications like vasovagal reactions or cardiac arrest.

While 67.3% of patients experienced complications, most were mild sensory deficits; however, 28.1% faced more serious issues, including dysesthesia and moderate to severe sensory loss, highlighting the need for thorough preoperative patient education about potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical difficulties and perioperative complications of retrogasserian glycerol rhizotomy for trigeminal neuralgia. Blomstedt, PC., Bergenheim, AT.[2017]

Trigeminal somatosensory evoked potentials (TSEPs) can accurately predict the prognosis of patients with unilateral trigeminal nerve lesions, as demonstrated in two case studies.

In one case, TSEPs indicated a positive outcome with the patient regaining sensation, while in another case, TSEPs suggested a poor prognosis, highlighting their potential utility in guiding treatment decisions like nerve grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of trigeminal somatosensory evoked potentials in the investigation of unilateral lesion of the inferior dental nerve: report of 2 cases. Fagade, OO.[2016]

Percutaneous radiofrequency rhizotomy (PSR) is a safe and effective surgical option for treating trigeminal neuralgia, with low rates of pain recurrence.

The recurrence rates of pain after PSR are lower than those seen with other percutaneous procedures and are comparable to the rates following microvascular decompression, highlighting its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of trigeminal neuralgia by percutaneous radiofrequency rhizotomy. Taha, JM., Tew, JM.[2005]

A new method for mapping the trigeminal nerve root during surgery was tested on 15 patients, using electrophysiological techniques to improve surgical precision.

This technique helps identify specific fiber subdivisions of the trigeminal nerve, aiding in safer and more effective microsurgical procedures for conditions like trigeminal neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative mapping of the trigeminal nerve root: technique and application in the surgical management of facial pain. Stechison, MT., Møller, A., Lovely, TJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05738096?cond=Pain%20Responses&aggFilters=status:rec&page=4&rank=32

Trigeminal Evoked Responses to Improve Rhizotomy TGN patients recruited for this study will already be undergoing percutaneous rhizotomy surgery. TSEPs will be measured at baseline prior to surgery. During the ...

2. withpower.com withpower.com/trial/early-phase-1-trigeminal-neuralgia-2-2023-cdb45

TSEP + Rhizotomy for Trigeminal Neuralgia Trial Overview The study tests if measuring brain responses (TSEPs) during rhizotomy surgery can help in treating trigeminal neuralgia. Participants will either ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465919/

Radiofrequency rhizotomy for multiple sclerosis–related ... Efficacy and clinical outcomes of percutaneous treatments for trigeminal neuralgia secondary to multiple sclerosis. Clin Neurol Neurosurg ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846722002931

Robotic-assisted stereotactic percutaneous balloon ... In this paper, we describe for the first time the clinical use of robotic-assistance to perform a PBC for TN, presenting our experience in two patients.

5. thejns.org thejns.org/focus/view/journals/neurosurg-focus/59/3/article-pE8.xml

Impact of preoperative medical management on postoperative ... Initial medical management fails in nearly half of patients with trigeminal neuralgia (TN), and patients will seek surgical management with either rhizotomy or ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5735194/

Impact of pain and postoperative complications on patient ... The present article reports on reduced quality of life measures undergoing otherwise successful MVD surgery for trigeminal neuralgia and following open partial ...