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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGN patients | Experimental | Patients with TGN who will undergo rhizotomy surgery as the standard of care |
|
| Healthy volunteers | Active Comparator | Healthy volunteers for whom TSEPS will be recorded in a lab setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSEP + rhizotomy surgery | Other | TGN patients recruited for this study will already be undergoing percutaneous rhizotomy surgery. TSEPs will be measured at baseline prior to surgery. During the rhizotomy procedure, an electrode or balloon is placed through a metal sheath to then damage the nerve. A stylet is introduced to clear tissue from the sheath in preparation for the electrode or balloon. Prior to the final insertion of the RF electrode where the gasserian ganglion will be damaged, we will place a standard stereotactic EEG electrode (SEEG). Following damaging the nerve (clinical procedure), we will record again to measure differences in the TSEPs following cell body damage. The Neuralynx system will be used to record the potentials at 40 KHz. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | total study procedure completion rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| TSEPS peak to peak amplitude within TGN | difference in measured peak to peak amplitude between normal and TGN side | 1 day |
| TSEPS latency within TGN | difference in measured TSEPS latency between normal and TGN side |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Maple | Contact | 612-626-3582 | maple036@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| David P Darrow, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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|
| TSEPs recording only | Other | TSEPS will also be recorded from healthy controls in a lab setting; all procedures for the healthy controls will be non-invasive. |
|
| 1 day |
| TSEPS peak to peak amplitude between control and TGN patients | difference in measured peak to peak amplitude between healthy participants and TGN patients | 1 day |
| TSEPS latency between control and TGN patients | difference in latency between healthy participants and TGN patients | 1 day |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |