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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Cascade 32 PRO will be to gently deliver electrical pulses.
University of Texas Medical Branch
Galveston, Texas, United States
RECRUITINGSafety 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.
Time frame: 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.
Time frame: Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).
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."
Time frame: At baseline, Perioperative/Periprocedural, immediately post-procedure, and at following post-op times 2-4 hours, 7 days, 30 days, and 90 days.
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.
Time frame: 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.
Time frame: At 24 hours, 7 days, 30 days, and 90 days after the procedure.
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Number of Adverse Events
Adverse events and serious adverse events including seizures, vascular complications, and signs of lidocaine toxicity.
Time frame: Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.