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Comparison of invasive measurement of craniospinal compliance with the noninvasively derived surrogate parameter from head electrical capacitance

Comparison of invasive measurement of craniospinal compliance with the noninvasively derived surrogate parameter from head electrical capacitance - NiCCa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032337
Enrollment
52
Registered
2023-07-21
Start date
2023-06-01
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

G91.2

Interventions

Group 1: Patients with normal pressure hydrocephalus (NPH) and spontaneous intracranial hypotension (SIH)

Sponsors

Klinik für Neurochirurgie - Uniklinik Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Suspected diagnosis of a cerebrospinal fluid circulation disorder Age > 18 years Presence of imaging of the neurocranium Clinical indication for the performance of a CSF infusion test Written consent

Exclusion criteria

Exclusion criteria: Intracranial tumour/malformation or tumour/malformation on the head (with the exception of malformations associated with the CSF circulation disorders mentioned above). - Contraindication to a lumbar infusion test - Non-removable external foreign bodies or large tattoos on head and neck - Pregnancy or breastfeeding - Patch allergy

Design outcomes

Primary

MeasureTime frame
craniospinal compliance resp. Electrical capacity of the head Non-invasively measured blood pressure Respiratory and cardiac activity

Secondary

MeasureTime frame
Diagnosed aetiology of hydrocephalus, clinical parameters of gait disturbances, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headaches, visual acuity, parameters of the computerised lumbar infusion test (baseline CSF pressure, pressure-volume index, pulse amplitude), documented intracranial pressures, cell count and total protein in the CSF, diameter of the sonographic optic nerve sheath (ONSD), radiological findings.  The following additional variables will be collected:   Age and gender of the study participants, BMI, height, presence of comorbidities using the Charlson Comorbidity Index (CCI).  previous cranial operations, presence of cranial implants.

Countries

Germany

Contacts

Public ContactMukesch Johannes Shah

Klinik für Neurochirurgie

mukesch.shah@uniklinik-freiburg.de07612705001

Outcome results

None listed

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