Validation of a non-invasive measured surrogate parameter for craniospinal compliance by measuring the electrical capacity of the head

Validation of a non-invasive measured surrogate parameter for craniospinal compliance by measuring the electrical capacity of the head - NiDCeC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022513

Enrollment

180

Registered

2020-07-27

Start date

2023-10-01

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

G91.0 G97.0

Interventions

Group 1: Patients with cerebrospinal fluid circulation disorder. Measurement of the so-called Respiratory Amplitude Quotient (RAQ) in a seated and supine position Group 2: Patients without cerebrospin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Suspicion of the presence of a liquor circulation disturbance.

Exclusion criteria

Exclusion criteria: Plaster allergy (possible skin irritation caused by the electrodes), and patients unable to give consent.

Design outcomes

Primary

Measure	Time frame
Respiratory Amplitude Coefficient (RAQ)	—

Secondary

Measure	Time frame
clinical parameters of gait disorders, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headache, visual acuity, parameters of the computerized lumbar infusion test (baseline CSF pressure, pressure-volume index, pulse amplitude), documented intracranial pressures, cell count and total protein in CSF, diameter of the sonographic optic nerve sheath (ONSD), radiological findings. Age and sex of study participants, BMI, height, presence of comorbidities based on the Charlson comorbidity index (CCI) previous cranial operations, presence of cranial implants. The parameters are collected at the initial examination and, in patients with CSF circulation disorders, at follow-up examinations (always after 3 months).	—

Measure

Time frame

clinical parameters of gait disorders, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headache, visual acuity, parameters of the computerized lumbar infusion test (baseline CSF pressure, pressure-volume index, pulse amplitude), documented intracranial pressures, cell count and total protein in CSF, diameter of the sonographic optic nerve sheath (ONSD), radiological findings. Age and sex of study participants, BMI, height, presence of comorbidities based on the Charlson comorbidity index (CCI) previous cranial operations, presence of cranial implants. The parameters are collected at the initial examination and, in patients with CSF circulation disorders, at follow-up examinations (always after 3 months).

—

Countries

Germany

Contacts

Public ContactMukesch Johannes Shah

Klinik für Neurochirurgie Uniklinik Freiburg

mukesch.shah@uniklinik-freiburg.de0761 27050010

Outcome results

None listed

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