Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

Hydrocephalus is a serious condition in which fluid builds up inside the brain, often requiring lifelong surgical placement of a shunt to drain excess cerebrospinal fluid (CSF). One of the most common causes of hydrocephalus is bleeding into the brain's fluid spaces after aneurysm rupture, prematurity, or infection. Currently, no medication exists to prevent hydrocephalus from developing after these injuries. The investigators' recent research suggests that hydrocephalus may result not only from blocked fluid pathways but also from harmful inflammation within the brain's ventricular system. The investigators discovered that inflammation activates the choroid plexus, the tissue that produces CSF, causing excessive CSF production and inflammatory injury to the ventricular lining and surrounding brain tissue. The investigators also identified inflammatory biomarkers and extracellular vesicles in human CSF that may enable real-time monitoring of these disease processes.

In this project, the investigators will perform a first-in-human pilot study testing whether targeted "intraventricular mTOR inhibition" can reduce ventricular inflammation and prevent hydrocephalus after severe brain hemorrhage. The medication will be delivered via temporary ventricular drains already in place as part of routine clinical care. The investigators will study safety, inflammation, CSF production, brain imaging changes, and whether patients ultimately require permanent shunts. Although this initial study focuses on adults with hemorrhage-related hydrocephalus, our long-term goal is to develop non-surgical therapies that could help children with hydrocephalus caused by prematurity or infection, especially in regions where access to neurosurgical care and shunt surgery is limited.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH)

Hunt Hess grade IV to V

Radiographic evidence of intraventricular hemorrhage (IVH)

Disqualifiers

Pre-existing ventriculoperitoneal shunt dependence

Severe baseline immunosuppression

Uncontrolled systemic infection unrelated to hemorrhage

Pregnancy

Trial design

Design model

Sequential

Treatments tested in this trial

  • Sirolimus (Rapamune®)

    Drug

    Ventricular delivery

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain HemorrhageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CSF rapamycin concentration

The concentration of rapamycin will be measured in serial CSF samples collected longitudinally through EVDs.

Time frame
Baseline, 7 days, and 14 days after rapamycin treatment.

Secondary outcomes

1

Change in Evans Index

Longitudinal change in the Evans index measured on serial brain MRI to assess ventricular enlargement and progression toward hydrocephalus.

Time frame
Baseline, 7 days, and 14 days after rapamycin treatment.
2

Change in Frontal-Occipital Horn Ratio (FOHR)

Longitudinal change in the frontal-occipital horn ratio measured on serial brain MRI as a marker of ventricular size.

Time frame
Baseline, 7 days, and 14 days after rapamycin treatment.
3

Change in Third Ventricular Width

Longitudinal change in third ventricular width measured on serial brain MRI to evaluate ventricular remodeling.

Time frame
Baseline, 7 days, and 14 days after rapamycin treatment.
4

Change in Ventricular Volume

Change in total ventricular volume quantified by MRI-based volumetric segmentation, when imaging quality permits, to explore treatment effects on ventricular remodeling.

Time frame
Baseline, 7 days, and 14 days after rapamycin treatment.

Other outcomes

Sponsors and contacts

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