TSEP + Rhizotomy for Trigeminal Neuralgia
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Facial pain, Migraine, Fibromyalgia, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment TSEP + Rhizotomy for Trigeminal Neuralgia?
The research indicates that percutaneous stereotaxic rhizotomy (PSR), a similar procedure to the rhizotomy part of the treatment, has shown good long-term results in treating trigeminal neuralgia, with 61% of patients experiencing excellent outcomes. Additionally, trigeminal somatosensory evoked potentials (TSEPs) have been useful in diagnosing and managing trigeminal nerve issues, suggesting they could help guide effective treatment.
12345Is TSEP + Rhizotomy generally safe for humans?
The safety of TSEP + Rhizotomy for trigeminal neuralgia shows that while complications can occur, they are mostly mild and non-disabling, though some long-lasting side effects have been reported. TSEPs are non-invasive and have been used to assess nerve function, suggesting a level of safety in their application.
16789How is the TSEP + Rhizotomy treatment for trigeminal neuralgia different from other treatments?
The TSEP + Rhizotomy treatment for trigeminal neuralgia is unique because it combines trigeminal somatosensory evoked potentials (TSEPs), which help assess nerve function, with rhizotomy, a surgical procedure that targets nerve roots to relieve pain. This approach may offer a more precise and objective method to guide the surgical intervention compared to traditional rhizotomy alone.
134510Eligibility Criteria
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 18 years old or older.
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.
+2 more
Trial Timeline
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
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Trigeminal somatosensory evoked potentials. A review of the literature as applicable to oral dysaesthesias. [2019]Oro-facial sensory impairment is a common event following third molar extractions, osteotomies and maxillo-facial trauma. Trigeminal somatosensory-evoked potentials (TSEPs) may offer an objective means of assessing neuronal function in such cases. TSEPs may be recorded non-invasively in man following peripheral stimulation of the trigeminal nerve, the principal nerve of oro-facial sensation. TSEP recording has gained popularity over the last decade and it is thus timely to review experimental methods and proven clinical applications in the light of recent interest in this technique within oral and maxillo-facial surgery.
Intraoperative mapping of the trigeminal nerve root: technique and application in the surgical management of facial pain. [2019]A method for intraoperative topographic mapping of the trigeminal nerve root using electrophysiological methods is described. A series of 15 patients under general anesthesia during microvascular decompression and selective posterior fossa trigeminal rhizotomy was studied. This method was used to study the localization of fibers of individual subdivisions of the intradural portion of the trigeminal nerve and as a guide for performing physiologically controlled, selective, microsurgical trigeminal rhizotomy.
Applications of trigeminal somatosensory evoked potentials in the investigation of unilateral lesion of the inferior dental nerve: report of 2 cases. [2016]2 cases were reported in which trigeminal somatosensory evoked potential (TSEPs) confirmed the presence of unilateral lesions of branches of the trigeminal nerve, and were used to predict the prognosis. The TSEPs allowed an accurate prediction of the prognosis. The first patient regained sensation on the numb side of the tongue as predicted from the TSEPs, whilst the TSEPs also predicted a poorer prognosis for the second patient, who might not regain sensation on the numb side of the tongue unless a successful nerve grafting was done. TSEPs could indeed be very useful in the management of lesions involving the trigeminal nerve, and especially in the follow-up investigations.
[Possibilities of trigeminal somatosensory evoked potentials in diagnosing neuralgiform facial pain]. [2006]The aim of this study was to analyse the possibilities of trigeminal somatosensory evoked potentials (TSEP) as an objective diagnostic tool for the classification of pain sensations of the 5th cranial nerve. 43 patients suffering from trigeminal neuralgia, atypical facial pain and cancer pain were investigated. Pain sensations of patients correlated with changes in the somatosensory evoked response by presenting an increase in latency periods. Specific pathological peaks could not be found, and thus it must be concluded that TSEP changes should be interpreted only in the light of the clinical symptoms.
a 10-year experience in the treatment of trigeminal neuralgia. Comparison of percutaneous stereotaxic rhizotomy and posterior fossa exploration. [2022]Of 1000 patients with classic trigeminal neuralgia who were treated during the last 10 years, 90% had an initial favorable response to medical therapy, but 75% (750 patients) failed to achieve satisfactory long-term relief. Of these, 700 patients were treated by percutaneous stereotaxic rhizotomy (PSR) and 50 were selected for posterior fossa exploration (PFE). Of the 50 patients undergoing PFE, 82% had neurovascular contact at the trigeminal root entry zone, but only 46% were judged to have had significant neurovascular compression. Exploration was negative in 16% of patients and revealed neural compression by bone in 2%. Patients with neurovascular compression were treated by microvascular decompression (MVD); all other patients with exploratory surgery underwent partial sensory rhizotomy. At 3 years after PFE, 84% of patients are pain-free. Results are excellent in 68%, good in 12%, fair in 4%; 12% had a recurrence of their neuralgia. The 700 patients treated by P SR have been followed for 6 years. Results area excellent in 61%, good in 13%, fair in 5%, and poor in 1%; 20% had a recurrence. This study indicates that there is no significant difference in results between PSR and PFE in the treatment of trigeminal neuralgia. The concept that neurovascular compression is a mechanical factor in the etiology of trigeminal neuralgia was supported, but neurovascular compression was less common than previously reported. Percutaneous stereotaxic rhizotomy is a less formidable procedure than PFE, and is easily repeated. Recent technical advances have improved the results obtained with PSR. Therefore, PSR remains the procedure of choice for the majority of patients with trigeminal neuralgia.
Technical difficulties and perioperative complications of retrogasserian glycerol rhizotomy for trigeminal neuralgia. [2017]In 139 patients, 260 consecutive retrogasserian glycerol rhizotomies for trigeminal neuralgia were retrospectively analyzed regarding technical surgical difficulties and immediate and early complications. Technical obstacles occurred in 47.3%. In 21 cases (8.1%), the surgical procedure had to be interrupted due to circumstances such as vasovagal reactions, cardiac arrest, or difficulties to find the trigeminal cistern. Complications or side effects, being either transient or persistent, occurred in 67.3%. In the vast majority, those unwanted effects were related to mild sensory deficits. However, in 28.1% the complications were other than mild affection of facial sensibility. These slightly graver complications included labial herpes (3.8%), anesthesia dolorosa (0.8%), moderate or severe affection of sensibility (18.8%), dysesthesia (22.7%), chemical meningitis (1.5%) and infectious meningitis (1.5%). In 5 patients (1.9%) hearing was affected. In one of them, this condition was also brought about by tinnitus, and in another patient a preexisting tinnitus deteriorated. Although the frequency of surgical difficulties was high, the success of the glycerol injection was hampered only in a minor number of procedures. The frequency of complications and side effects was high, but they were mostly mild due to their nature and non-disabling for the patient. However, long-lasting disabling side effects occurred, and this should not be neglected when informing patients preoperatively. The surgical training needed to perform the procedure is stressed, and the use of prophylactic antibiotics when accidentally penetrating the oral bucca is recommended. We consider retrogasserian glycerol rhizotomy to be a good surgical option for patients with trigeminal neuralgia not suitable for microvascular decompression and when pharmacological therapy is not sufficient or is not tolerated.
Descending trigeminal tractotomy for trigeminal neuralgia after surgical failure. [2018]Percutaneous rhizotomy, microvascular decompression or rhizotomy by suboccipital craniotomy often cures medically untreatable trigeminal neuralgia with an acceptable complication rate. However, pain involving the same trigeminal distribution persists in a few patients despite both rhizotomies. For 7 patients with such surgically 'failed' trigeminal neuralgia, we performed descending trigeminal tractotomy. In all patients, neuralgia ceased immediately postoperatively and has not recurred during 9 months to 15 years follow-up. Descending trigeminal tractotomy provides a satisfactory solution to this relatively rare but paroxysmal pain syndrome.
Recordings of long-latency trigeminal somatosensory-evoked potentials in patients under general anaesthesia. [2011]The reliability of intra-operative recordings of trigeminal scalp-induced somatosensory-evoked potentials (T-SSEP) is controversial. This investigation aimed to provide evidence that T-SSEP recordings are stable using standardised neurophysiological methodology and anaesthesiological regime.
Treatment of trigeminal neuralgia by percutaneous radiofrequency rhizotomy. [2005]Percutaneous radiofrequency rhizotomy (PSR) is recognized as a simple, effective, and safe surgical treatment for trigeminal neuralgia. Rates of pain recurrence after PSR are the lowest versus those of other percutaneous procedures, and similar to those of microvascular decompression.
Peroral Trigeminal Rhizotomy Using a Novel 3-Dimensional Printed Patient-Specific Guidance Tool. [2022]Ganglion Gasseri rhizotomy is a viable therapeutic option for trigeminal pain (TP). For this neurosurgical procedure, different potential operative and technical nuances exist.