Trigeminal NeuralgiaNCT05269472
Trigeminal Neuralgia Electrophysiology
An observational study of Trigeminal Neuralgia, run by University of Minnesota at 1 site in United States.
Trial summary
The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Trigeminal Electrophysiology
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 7 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults of 18 years or older who are scheduled to undergo percutaneous rhizotomy for facial pain
Who may be able to join
- Adults of 18 years or older
- Scheduled to undergo percutaneous rhizotomy for facial pain
- Adults of 18 years or older
Who cannot join
- Facial pain of unclear origin (i.e. not clearly TGN pain)
- Rhizotomy procedure canceled
- Diagnosis or history of facial pain such as TMD or TGN
- History of migraine
- History of any functional pain disorder: fibromyalgia, IBS, CRPS
- Recent chronic pain (within last month)
- Unwilling to participate for two hours in lab
- Current acute pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Matthew Maple, 612-946-1424, maple036@umn.edu
About this study
Official title: Trigeminal Evoked Responses to Improve Rhizotomy
The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. The evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (EEG) and at the gasserian ganglion through an FDA-approved recording electrode.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Trigeminal Electrophysiology
- Keywords
- Trigeminal Neuralgia
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigeminal ElectrophysiologyProcedure or surgery
This study will pilot and test the feasibility of introducing electrophysiology into the routine rhizotomy procedure by including trigeminal somatosensory evoked potentials (TSEPs) and recording from electrodes at the level of the ganglion.
| Study group | Role | What they receive |
|---|---|---|
| Trigeminal Electrophysiology | Not described Receives: Procedure: Trigeminal Electrophysiology | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of measuring trigeminal somatosensory evoked potentials to improve personalized mapping during percutaneous rhizotomy
percentage of consented participants who complete the study
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start4 Apr 2022
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Darrow, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269472
- Sponsor's protocol ID
- NSU-2022-30582
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigeminal Evoked Responses to Improve Rhizotomy
- ClinicalTrials.gov ID
- NCT05269472
- Acronym / sponsor ID
- NSU-2022-30582
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. The evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (EEG) and at the gasserian ganglion through an FDA-approved recording electrode.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trigeminal Electrophysiology | – | Procedure: Trigeminal Electrophysiology |
| Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults of 18 years or older who are scheduled to undergo percutaneous rhizotomy for facial pain
Key inclusion criteria (3 listed)
- Adults of 18 years or older
- Scheduled to undergo percutaneous rhizotomy for facial pain
- Adults of 18 years or older
Key exclusion criteria (8 listed)
- Facial pain of unclear origin (i.e. not clearly TGN pain)
- Rhizotomy procedure canceled
- Diagnosis or history of facial pain such as TMD or TGN
- History of migraine
- History of any functional pain disorder: fibromyalgia, IBS, CRPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trigeminal ElectrophysiologyThis study will pilot and test the feasibility of introducing electrophysiology into the routine rhizotomy procedure by including trigeminal somatosensory evoked potentials (TSEPs) and recording from electrodes at the level of the ganglion. | Procedure or surgery | Trigeminal Electrophysiology |
Primary outcome
Determine the feasibility of measuring trigeminal somatosensory evoked potentials to improve personalized mapping during percutaneous rhizotomy
Time frame: 3 years
percentage of consented participants who complete the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Darrow principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Maple (612-946-1424, maple036@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the feasibility of measuring trigeminal somatosensory evoked potentials to improve personalized mapping during percutaneous rhizotomy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.