Effects of Cerebrospinal Fluid Drainage on Cerebral Hemodynamics

Summary

This pilot interventional study investigates whether continuous cerebrospinal fluid (CSF) drainage via lumbar drain can improve cerebrovascular reactivity (CVR) in patients with acute ischemic stroke and hemodynamic failure, as assessed by blood oxygenation level dependent (BOLD) MRI.

Patients with acute ischemic stroke frequently exhibit impaired cerebral autoregulation and reduced vascular reserve. In such cases, a low BOLD-CVR response is associated with a high (\~40%) risk of recurrent ischemic stroke despite optimal medical therapy. Hemodynamic failure stage 2 (HF2), defined by severely reduced CVR (hemispheric BOLD-CVR ≤ 0.1041), indicates exhausted compensatory capacity and poor perfusion.

Evidence from other neurological conditions suggests that CSF drainage via lumbar drain may transiently lower intracranial pressure, improve perfusion, and enhance autoregulatory function. This study aims to apply these findings to acute stroke patients with hemodynamic compromise.

Eligible patients will undergo BOLD-CVR MRI to assess cerebrovascular reserve. Those meeting HF2 criteria and without contraindications will be offered inclusion. After informed consent (or proxy consent), a lumbar drain will be placed, and continuous CSF drainage performed over \~48 hours. A follow-up BOLD-CVR MRI will assess changes in CVR. In addition, 20 ml of CSF will be extracted to evaluate acute effects on CVR. A historical cohort will be used to control for spontaneous CVR variation over 48 hours.

Primary Objective:

To determine whether continuous CSF drainage improves BOLD-CVR in patients with HF2 following acute ischemic stroke.

Secondary Objectives:

To compare longitudinal BOLD-CVR changes to a historical cohort. To evaluate safety and feasibility of lumbar drainage in this setting. To assess short-term clinical outcomes (NIHSS, mRS) and recurrent events. To assess BOLD-CVR change after 20 ml CSF extraction.

Study Design:

Single-center, open-label, prospective pilot study. Participants serve as their own control, with pre- and post-intervention imaging to evaluate physiological effects. Safety and exploratory clinical data will also be collected.

This proof-of-concept trial aims to generate preliminary evidence for a potential therapeutic strategy in high-risk stroke patients with poor autoregulation. Positive findings could inform future randomized controlled trials.

Conditions

• Acute Ischemic Stroke

Interventions

PROCEDURE

Lumbar drain placement

This intervention involves temporary cerebrospinal fluid (CSF) drainage via lumbar drain in acute ischemic stroke patients with MRI-confirmed hemodynamic failure. The lumbar drain is inserted at the bedside or in a procedural suite under sterile conditions and connected to a pressure-regulated, closed drainage system. Drainage is continuous for 48-72 hours, with volume and pressure carefully monitored. This intervention is distinct in targeting stroke patients without hydrocephalus, using CSF drainage as a novel method to improve cerebral perfusion and vascular reserve. The effect is evaluated with serial BOLD-CVR MRI performed before and after the drainage period, making this one of the first interventional stroke studies to use functional MRI as a physiological endpoint.

Sponsors & Collaborators

• University of Zurich

  lead OTHER

Principal Investigators

• Christiaan HB van Niftrik, MD PhD · University of Zurich

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-01

Primary Completion

2027-10-30

Completion

2028-01-30

Countries

• Switzerland

Study Locations