NCT06745648 Carotid Sinus Massage in Trendelenburg Position for Headache Relief
| NCT ID | NCT06745648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Municipal Pedro T. Orellana |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-12-21 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2024-12-21 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Headaches significantly impact patients' quality of life, with tension-type headaches and migraines being among the most prevalent types. There is growing evidence suggesting that blood pressure regulation and baroreceptor activity play a role in headache pathophysiology. Carotid sinus massage (CSM), particularly when combined with the modified Trendelenburg position, may modulate autonomic nervous system activity to relieve headache symptoms. An initial open-label pilot study (n = 17) was completed, and the results were published in a preprint server for health sciences, the Medical Research Archive (medRxiv), demonstrating the feasibility, safety, and promising preliminary efficacy of CSM+T. Based on these findings, a follow-up randomized, sham-controlled, parallel-arm trial will further evaluate the efficacy of the treatment.
Eligibility Criteria
INCLUSION CRITERIA: * Participants must be at least 16 years of age. * Must have a diagnosis of one of the following, according to the International Classification of Headache Disorders (ICHD-3): * Migraine * Tension-type headache * Mixed headache * The headache episode must have started within the past 24 hours. EXCLUSION CRITERIA: * Any contraindication to carotid sinus massage, including: * Carotid bruits * Recent myocardial infarction * History of stroke * Known or suspected carotid artery stenosis * Any contraindication to the Trendelenburg position, including: * Increased intracranial pressure * Respiratory distress * Congestive heart failure * History of syncope * History of cardiac arrhythmias
Contact & Investigator
Pablo D Anaya, MD
PRINCIPAL INVESTIGATOR
Hospital Municipal Pedro T. Orellana
Frequently Asked Questions
Who can join the NCT06745648 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06745648 currently recruiting?
Yes, NCT06745648 is actively recruiting participants. Contact the research team at heberto.suarez.roca@duke.edu for enrollment information.
Where is the NCT06745648 trial being conducted?
This trial is being conducted at Trenque Lauquen, Argentina.
Who is sponsoring the NCT06745648 clinical trial?
NCT06745648 is sponsored by Hospital Municipal Pedro T. Orellana. The principal investigator is Pablo D Anaya, MD at Hospital Municipal Pedro T. Orellana. The trial plans to enroll 18 participants.
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