Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety of Bipolar external carotid artery circulation Stimulation
研究概览
简要总结
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.
详细描述
Once the patient agree to participate in this study and sign the consent form, will be asked to complete the following tests and procedures:
- Be prepped to undergo the planned standard of care MMA lidocaine infusion procedure.
- Before infusion, the doctors will briefly deliver electrical stimulation using the Cadwell Cascade 32 PRO device through microwires already in the artery. The use of this device for stimulation in the MMA is not approved by the FDA and is investigational.
- Stimulation will be given for about 5 minutes on each side.
- During stimulation with Cadwell Cascade 32 PRO, your vital signs, neurologic status, and headache severity (on a 0-10 scale) will be recorded. The Cadwell Guardian IONM System device will also be used for continuous monitoring during stimulation. The use of this device for monitoring is approved by the FDA.
- After stimulation, you will receive lidocaine infusion into the MMA (50 mg over 15 minutes) as planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Single intervention arm
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.
干预措施: Cadwell Cascade 32 PRO (Device)
结局指标
主要结局
Safety of Bipolar external carotid artery circulation Stimulation
时间窗: 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
时间窗: 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.
次要结局
- 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.)
- Physiologic Responses During Stimulation(Perioperative/Periprocedural)
- Patient-Reported Qualitative Outcomes(At 24 hours, 7 days, 30 days, and 90 days after the procedure.)
- Number of Adverse Events(Perioperative/Periprocedural, and at follow-up at 7 days, 30 days, and 90 days.)