Health TrialsbyHealthPanel

Stimulation of External Carotid Artery Circulation

ConditionMigraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadwell Cascade 32 PRO

    Device

    Cascade 32 PRO will be to gently deliver electrical pulses.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Single intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured Perioperative/Periprocedural and through the immediate post-procedural period (up to 24 hours).
2

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).

Secondary outcomes

1

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.
2

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
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Medical Branch, Galveston

Lead sponsor

Source ClinicalTrials.gov
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