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NCT05738096 · ClinicalTrials.gov registry record · Early Phase 1
Trigeminal Evoked Responses to Improve Rhizotomy
A Early Phase 1 study of Trigeminal Neuralgia and Rhizotomy, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05738096: Recruiting Early Phase 1 study of Trigeminal Neuralgia and Rhizotomy, sponsored by University of Minnesota.
NCT05738096 is a Early Phase 1 study of Trigeminal Neuralgia and Rhizotomy that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 30 participants, below the 5,766-participant average among 9 other Trigeminal Neuralgia trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05738096, a Early Phase 1 study of Trigeminal Neuralgia and Rhizotomy, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
total study procedure completion rate
Conditions Studied
Interventions
- OTHER TSEP + rhizotomy surgery
- OTHER TSEPs recording only
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2026-11-01 |
| Phase | Early Phase 1 |
What NCT05738096 shows while recruiting
NCT05738096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 5,766-participant average among 9 other Trigeminal Neuralgia trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Trigeminal Neuralgia appearing as the primary indexed condition, and to 2 interventions - of which TSEP + rhizotomy surgery is the first listed.
NCT05738096 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05738096 about?
NCT05738096 is a clinical study titled "Trigeminal Evoked Responses to Improve Rhizotomy". 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 ...
What is the current status of trial NCT05738096?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2023-11-01. Estimated completion is 2026-11-01.
What conditions does trial NCT05738096 study?
This clinical trial studies the following conditions: Trigeminal Neuralgia, Rhizotomy.
What interventions are being tested in trial NCT05738096?
The interventions under investigation include: TSEP + rhizotomy surgery (OTHER), TSEPs recording only (OTHER).
Who is sponsoring clinical trial NCT05738096?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05738096 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05738096's enrollment target sits among peer trials
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