Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein

NCT07053631 | Recruiting

• 1 other identifier: VOPxICP pilot-study
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Elevated intracranial pressure (ICP) occurs when pressure inside the skull rises above normal levels, potentially leading to brain damage or herniation. Monitoring ICP is critical for managing conditions like brain tumors, traumatic brain injury, and stroke. Current ICP monitoring methods are invasive and carry risks, including infection and brain damage. For less severe cases, lumbar puncture is a safer, less invasive alternative. This study explores the potential of a non-invasive method, using venous pressure near the eye, to estimate ICP. The goal is to assess whether the results from this non-invasive approach are similar to the invasive lumbar CSF pressure measurements.

Conditions

Indication for CSF Dynamic Testing; Indication for CSF Infusion Test

Keywords

ICP; non-invasive ICP assessment

Outcome Measures

Primary Outcomes (2)

• Venous occlusion pressure measurement (mmHg)

  Mean venous occlusion pressure of one isolated target periorbital frontal vein of 6 consecutive measurements in mmHg (mask inflated) during routine infusion test in recumbent lateral position

  60 minutes

• intracranial Pressure (ICP) in mmHg

  Invasive lumbar intracranial pressure measurements in mmHg (mean over a 1-minute window aligned with start of venous occlusion measurements, in mmHg) during routine infusion test in recumbent lateral position

  60 minutes

Secondary Outcomes (15)

• Measurement of venous occlusive pressure in mmHg

  60 minutes

• Measurement of average systolic ICP in mmHg

  60 minutes

• Measurement of average diastolic ICP in mmHg

  60 minutes

• Relationship of venous occlusion pressure measured in mmHg compared to average ICP-Amplitude in mmHg

  60 minutes

• Measurement of elastance of the craniospinal system measured in ml

  60 minutes

Study Arms (1)

Venous occlusion pressure measurements

EXPERIMENTAL

Device: venous occlusion pressure Measurement

Interventions

venous occlusion pressure Measurement DEVICE

non-invasive venous occlusion pressure of a targeted periorbital vein is measured in parallel to clinical standard CSF dyanmic testing including standard CSF infusiontest

Venous occlusion pressure measurements

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical indication to perform routine craniospinal CSF dynamic testing according to standard operative procedures
• Aged 18-95
• Willing and able to provide valid signed informed consent

You may not qualify if:

• Patients with any known ongoing, or history of, abnormal CSF communication
• Patients with any kind of prior intervention for CSF diversion
• Patients with acute brain damage within the preceding 6 months
• Patients with transdural surgery within the preceding 6 months
• Head wounds or hematoma that could hinder access to measurement site
• Any known pathological condition linked to the orbital socket influencing venous outflow

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

Klinik für Neurochirurgie, Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Central Study Contacts

Katharina Wolf

CONTACT

+4976127050010; katharina.wolf@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Funktionsoberärztin Leiterin der Liquorzirkulations-Ambulanz Fachärztin für Neurologie

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: July 8, 2025
• Study Start: April 7, 2025
• Primary Completion: December 6, 2025
• Study Completion: December 8, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)