Migraine
Conditions
Keywords
Migraine, External carotid artery circulation, Bipolar Stimulation
Brief summary
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.
Interventions
DEVICECadwell Cascade 32 PRO
Cascade 32 PRO will be to gently deliver electrical pulses.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Chronic migraine or status migrainosus, or craniofacial pain refractory to maximal medical therapy who are undergoing MMA IA lidocaine infusion. * Subject has provided informed consent.
Exclusion criteria
* Known allergies to lidocaine * Seizure disorder, history of seizures, or increased seizure susceptibility * Intracranial vascular malformations or dural AVF * Hemodynamic instability, any condition where brief hemodynamic shifts may pose risk * Previous MMA intervention or craniotomy that could result in MMA occlusion * Any implanted electronic device (pacemaker, ICD, DBS, VNS, cochlear implant, spinal cord stimulator) * Significant cardiovascular disease (unstable angina, severe arrhythmias, recent MI) * Severe autonomic dysfunction * Active systemic infection * Vulnerable populations (i.e. pregnant individuals, children, prisoners, individuals lacking decision-making capacity, persons with cognitive impairment, those unable to provide informed consent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Bipolar external carotid artery circulation Stimulation | Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours). | Safety will be evaluated based on the ability to complete the stimulation procedure without technical failure, serious complications, or procedure-related neurological deficits. |
| Feasibility of Bipolar external carotid artery circulation Stimulation | Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours). | Feasibility will be demonstrated if stimulation can be successfully initiated and completed using the intended bipolar approach. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic Responses During Stimulation | Perioperative/Periprocedural | Physiologic responses, including heart rate, blood pressure, respiratory rate, and oxygen saturation, will be recorded during active stimulation to assess acute physiologic effects. |
| Patient-Reported Qualitative Outcomes | At 24 hours, 7 days, 30 days, and 90 days after the procedure. | Patient-reported qualitative outcomes includes perceived headache relief, tolerability of the intervention, and the presence of any new or worsening symptoms. |
| Number of Adverse Events | Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days. | Adverse events and serious adverse events including seizures, vascular complications, and signs of lidocaine toxicity. |
| Headache Severity Measured by the Visual Analog Scale (VAS) | At baseline, Perioperative/Periprocedural, immediately post-procedure, and at following post-op times 2-4 hours, 7 days, 30 days, and 90 days. | 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." |
Countries
United States
Contacts
CONTACTMatias Costa, MD
CONTACTPatrick Karas, MD
PRINCIPAL_INVESTIGATORPeter Kan, MD,MPH
University of Texas Medial Branch
Outcome results
None listed