Non-invasive measurement of the intracranial pressure with the HeadSense HS-1000 compared to the conventional invasive measurement

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011211

Enrollment

Registered

2016-10-18

Start date

2016-11-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G93.2 G91.2

Interventions

Group 1: Patients of the Department of Neurosurgery of the Hospital of German Federal Armed Forces Ulm, who already got an invasive measurement device implanted. The patient gets informed and is as

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - invasive ICP-Device

Exclusion criteria

Exclusion criteria: - Unconsciousness - Lack of capacity for consent - Pregnancy - Lactation period - Infection of the auditory canal or ear - Latex allergy

Design outcomes

Secondary

Measure	Time frame
Further objectives are to evaluate handling and comfort of the device and the procedure of measurement. After the measurement, patient and user get a questionnaire to assess these characteristics.	—

Primary

Measure	Time frame
The objective of the study is to determine the precision of the Headsense device compared to the invasive measurement of ICP as the actual standard. To do this the ICP is measured simultaneously by the Headsense device and an invasive probe. Then the data gets transferred in a software and gets evaluated.	—

Countries

Germany

Contacts

Public ContactUwe Max Mauer

Abteilung Neurochirurgie Bundeswehrkrankenhaus Ulm

BwKrhsULMAbtXIINeurochirugie@bundeswehr.org0731-1710-2201

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026