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This study is testing a new approach to help people with migraine headaches. Researchers want to find out if using electrical stimulation to affect blood flow in the external carotid artery is safe and practical for helping control headaches.
The goal of the study is to determine whether this approach could improve headache symptoms and overall outcomes for people with migraines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intervention arm | Experimental | Participants will undergo the planned external carotid artery circulation procedure. Before the lidocaine infusion begins, bipolar stimulation will be delivered through the external carotid artery circulation. During stimulation, clinicians will record vital signs, neurologic status, and headache severity using a 0-10 scale. Continuous intra-procedural monitoring will also be performed. After bipolar stimulation is completed, participants will receive lidocaine infusion as planned. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadwell Cascade 32 PRO | Device | Cascade 32 PRO will be to gently deliver electrical pulses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Bipolar external carotid artery circulation Stimulation | Safety will be evaluated based on the ability to complete the stimulation procedure without technical failure, serious complications, or procedure-related neurological deficits. | Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours). |
| Feasibility of Bipolar external carotid artery circulation Stimulation | Feasibility will be demonstrated if stimulation can be successfully initiated and completed using the intended bipolar approach. | Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Severity Measured by the Visual Analog Scale (VAS) | Headache severity will be assessed using the Visual Analog Scale (VAS), a validated 0-10 cm scale in which participants indicate headache intensity by marking a point along a continuous line representing "no pain" to "worst pain." | At baseline, Perioperative/Periprocedural, immediately post-procedure, and at following post-op times 2-4 hours, 7 days, 30 days, and 90 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matias Costa, MD | Contact | 409-772-0330 | mlcosta@utmb.edu | |
| Patrick Karas, MD | Contact | 409-772-0330 | pjkaras@utmb.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Kan, MD,MPH | University of Texas Medial Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555-0133 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Physiologic Responses During Stimulation | Physiologic responses, including heart rate, blood pressure, respiratory rate, and oxygen saturation, will be recorded during active stimulation to assess acute physiologic effects. | Perioperative/Periprocedural |
| Patient-Reported Qualitative Outcomes | Patient-reported qualitative outcomes includes perceived headache relief, tolerability of the intervention, and the presence of any new or worsening symptoms. | At 24 hours, 7 days, 30 days, and 90 days after the procedure. |
| Number of Adverse Events | Adverse events and serious adverse events including seizures, vascular complications, and signs of lidocaine toxicity. | Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days. |
| D009422 | Nervous System Diseases |