Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage

Active, not recruiting

• Conditions: Headache; Subarachnoid Hemorrhage, Aneurysmal; Subarachnoid Hemorrhage

• Registration Number: NCT03604276
• Lead Sponsor: MaineHealth

Brief Summary

The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.

Detailed Description

Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Non-traumatic subarachnoid hemorrhage
• Age > 18 years
• Treated with external ventricular drainage

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Exclusion Criteria

• Pregnancy or lactation
• Age < 18 years
• Traumatic SAH

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.	10 days
Determination of correlation between the neuroinflammatory response and development of chronic headache.	1 year
Determination of correlation between the neuroinflammatory response and severity/presence of headache pain.	10 days

Secondary Outcome Measures

Name	Time	Method
Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH.	10 days
Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life.	1 year

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States