A Phase 4 interventional study of Lidocaine (drug) and Tx 360 in Aneurysmal Subarachnoid Hemorrhage (aSAH) and Headache, sponsored by Wright State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Wright State University · Phase 4, Interventional, and Treatment
Among 149 studies in Subarachnoid Hemorrhage with a site in United States — 31 open to participants now, 37 under way, 2 of them phase 3. Subarachnoid Hemorrhage · United States.
Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, this one is the 64th largest by planned enrollment of the 107 interventional ones, is one of 8 that started in 2024, is one of 17 in phase 4, reaches primary completion later than 9 of the 36 other live ones, and was the 138th registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's planned enrollment of 20 is below the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →31 of the 149 studies in Subarachnoid Hemorrhage with a site in United States are open now, in 6 countries. Each count lists the studies.
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →149 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 8 started in 2024.
Median enrollment 30 across the 107 interventional studies, 60 across the 42 observational. Of the 94 that completed or were terminated, 38 (40%) have results posted.
23 of 149 have an industry lead sponsor. The 10 most frequent:
Wright State University is the lead sponsor of 39 studies on the registry; 13 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Wright State University has 1 study filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
14 of the studies in Subarachnoid Hemorrhage with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06621329Phase 3University of California, DavisTransnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache | 2027-07 |
| NCT07116408Wright State UniversityIntranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage | 2026-11 |
| NCT06103201University of Maryland, BaltimoreHyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury | 2026-11-26 |
| NCT05230134Stanford UniversityCervical Sympathetic Block in Patients With Cerebral Vasospasm | 2026-12 |
| NCT06119061Aaron CookTelavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage | 2026-12 |
Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, from their registry updates:
In patients with bleeding from a brain aneurysm, severe headache is the most common complaint. However, the pain is difficult to treat. The use of standard pain medications is common, but pain control remains poor. Additionally, pain medicines have multiple side effects including sedation, interference with breathing, intestinal cramping, low blood pressure, and the risk of addiction. In the present study, the investigators will examine the use of a medication to block the sphenopalatine ganglion which is a bundle of nerves that includes nerves that cause head pain. This block is performed by spraying numbing medication into the back of the nasal cavity on both sides. This particular pain medication does not have the side effects discussed above. The purpose of the study is to see if this treatment will decrease pain without causing unwanted side effects.
All patients in the study will receive standard pain medicine as needed for headache. Information will be collected from the patient's medical chart on the amount of pain medication used and the amount of pain the patient describes having. The average pain will be calculated for the first 24 hours the patient is in the hospital. At that point, the patient will receive pain medication sprayed into the back of the nasal cavity on both sides. Patients will also receive this treatment 3 days later. Following these treatments, information will be obtained on the average amount of pain, and how much other pain medication is used.
The investigators will look at the amount of pain and the amount of other pain medicine used over the first 24 hours before the nasal pain medicine treatment and compare it to the time after the treatments to see if the amount of pain decreases and if the amount of other pain medicine needed decreases as well. Six months after discharge, the patient will be contacted by phone to find out more information about how much head pain they had after discharge from the hospital.
Spontaneous subarachnoid hemorrhage (SAH) accounts for up to 8% of strokes and affects approximately 30,000 individuals yearly in the US alone. Of those, ruptured intracranial aneurysm is the etiology up to 85% of the time. In these patients, severe headache is the most common complaint and its treatment is difficult and often inadequate. However, adequate. Opioids, often in escalating doses, are guideline recommended, but unfortunately they have significant side effects and are often not effective. There have been numerous trials looking at different treatments for the headache caused by SAH. There is an urgent need for an effective treatment with tolerable side effects. The pathophysiology of pain in aneurysmal subarachnoid hemorrhage (aSAH) is not well elucidated.
It is likely related to vasoactive and inflammatory byproducts of blood degradation in the subarachnoid space. The intracranial vessels themselves are abundantly innervated, predominantly by branches of the maxillary nerve. The sphenopalatine ganglion (SPG) is a possible target for intervention, as blockade has been shown to be effective in cluster headaches. The SPG is located near the maxillary nerve, which may explain why blockade is also useful in several other head pain disorders. A small, single center pilot study of seven patients evaluated a bilateral suprazygomatic pterygopalatine fossa blockade as a treatment for headache, and all the patients had clinically significant reductions in reported pain. This study aims to evaluate whether intranasal SPG blockade could provide an effective and minimally invasive treatment option to improve pain and possibly reduce opioid requirements in these patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Additionally, patients with to use of the Tx 360 device will be excluded. Contraindications include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment arm
Drug: Lidocaine (drug) · Device: Tx 360
Tx 360/lidocaine
Tx 360 device
Headache severity
Description of headache severity using the headache numerical rating scale. The scale is a subjective rating of headache pain. The scale ranges from 0-10 with 0 being no pain (minimum value, better outcome) and 10 being the worst pain imaginable (maximum value, worse outcome).
Time frame: Day 1 (day of consent) Patient receives first treatment. Pain will be recorded every 8 hours. Second treatment is on day 4. Pain will be recorded every 8 hours until discharge from the ICU, an average of 2 weeks, and at 6 months post discharge.
Opioid dose
Amount of morphine equivalents/opioids used for pain control
Time frame: 2 weeks (or duration of hospitalization)
Plan to share: No
Started May 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.
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Studies of the drug tested here: Lidocaine
Wright State University