Health TrialsbyHealthPanel

Trigeminal Evoked Responses to Improve Rhizotomy

ConditionsTrigeminal NeuralgiaRhizotomy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults of 18 years or older

Scheduled to undergo percutaneous rhizotomy for facial pain

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • TSEP + rhizotomy surgery

    Other intervention

    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.

  • TSEPs recording only

    Other intervention

    TSEPS will also be recorded from healthy controls in a lab setting; all procedures for the healthy controls will be non-invasive.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: TGN patientsExperimental treatment 1 intervention
Group B: Healthy volunteersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility

total study procedure completion rate

Time frame
3 years

Secondary outcomes

1

TSEPS peak to peak amplitude within TGN

difference in measured peak to peak amplitude between normal and TGN side

Time frame
1 day
2

TSEPS latency within TGN

difference in measured TSEPS latency between normal and TGN side

Time frame
1 day
3

TSEPS peak to peak amplitude between control and TGN patients

difference in measured peak to peak amplitude between healthy participants and TGN patients

Time frame
1 day
4

TSEPS latency between control and TGN patients

difference in latency between healthy participants and TGN patients

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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