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NCT06310200 · ClinicalTrials.gov registry record · Phase 1
Sphenopalatine Ganglion Block and Cold Induced Headaches
A Phase 1 study of Headache and Cold Induced Headache, sponsored by Wright State University.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06310200: Active Phase 1 study of Headache and Cold Induced Headache, sponsored by Wright State University.
NCT06310200 is a Phase 1 study of Headache and Cold Induced Headache that is active but no longer recruiting, run by Wright State University. The registered enrollment target is 30 participants, below the 155-participant average among 35 other Headache trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06310200, a Phase 1 study of Headache and Cold Induced Headache, is active but no longer recruiting, sponsored by Wright State University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block
Primary Outcome
The primary objective of this study is to determine if a sphenopalatine ganglion block, performed through intranasal atomization of 4% lidocaine, is able to prevent brain freeze. This study will be performed in two phases. The first phase will include a pre-medicated phase where the subjects will be required to rapidly drink up to ½ of a 32 fluid oz icecold slushy to induce a brain freeze. The second phase will commence when the subjects have returned to their normal pain free state, a minimum o
Conditions Studied
Interventions
- DRUG normal saline
- DRUG Lidocaine Topical 4% Topical Solution
- DRUG Bitrex
Study Locations (1)
Ohio
- Wright state emergency medicine offices - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 1 |
What the registry record for NCT06310200 still lists
NCT06310200 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 155-participant average among 35 other Headache trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Headache appearing as the primary indexed condition, and to 3 interventions - of which normal saline is the first listed.
NCT06310200 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06310200 about?
NCT06310200 is a clinical study titled "Sphenopalatine Ganglion Block and Cold Induced Headaches". The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain...
What is the current status of trial NCT06310200?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-01-01. Estimated completion is 2025-07-01.
What conditions does trial NCT06310200 study?
This clinical trial studies the following conditions: Headache, Cold Induced Headache, Brain Freeze, Cold Induced Cephalgia.
What interventions are being tested in trial NCT06310200?
The interventions under investigation include: normal saline (DRUG), Lidocaine Topical 4% Topical Solution (DRUG), Bitrex (DRUG).
Who is sponsoring clinical trial NCT06310200?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06310200 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06310200's enrollment target sits among peer trials
30 29th of 35 higher than 6 of 35 other Headache trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Headache trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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