Trigeminal Evoked Responses to Improve Rhizotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TSEP + rhizotomy surgery, TSEPs recording only.
- Who it may be relevant to
- Registry conditions: Trigeminal Neuralgia, Rhizotomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other TSEP + rhizotomy surgery
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 EE - Other TSEPs recording only
TSEPS will also be recorded from healthy controls in a lab setting; all procedures for the healthy controls will be non-invasive.
Primary outcome measures
- Feasibility [Time frame: 3 years]
Secondary outcome measures (4)
- TSEPS peak to peak amplitude within TGN [Time frame: 1 day]
- TSEPS latency within TGN [Time frame: 1 day]
- TSEPS peak to peak amplitude between control and TGN patients [Time frame: 1 day]
- TSEPS latency between control and TGN patients [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
- Adults of 18 years or older
- Scheduled to undergo percutaneous rhizotomy for facial pain
Exclusion criteria
- For TGN: Facial pain of unclear origin (i.e. not clearly TGN pain) or Rhizotomy procedure canceled
- For Healthy control: Diagnosis or history of facial pain such as TMD or TGN, History of migraine, History of any functional pain disorder: fibromyalgia, IBS, CRPS or Recent chronic pain (within last month)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05738096 · Rhizotomy