NCT05632302 is a NA clinical trial of nICP in Traumatic Brain Injury, sponsored by Crainio Ltda.

Who is sponsoring NCT05632302?

NCT05632302 is sponsored by Crainio Ltda.

What drugs are being tested in NCT05632302?

Interventions in NCT05632302: nICP.

What condition does NCT05632302 study?

NCT05632302 studies Traumatic Brain Injury, Intracranial Hypertension.

Is NCT05632302 still recruiting?

NCT05632302 is currently completed. Last updated 30 November 2022.

Last reviewed 2022-11-30 · How we verify

NCT05632302

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Non-invasive Intracranial Pressure (nICP) Monitoring System

Completed NA Last updated 30 November 2022

What this trial tests

NA trial testing nICP in Traumatic Brain Injury in 40 participants. Completed in 20 July 2021.

Timeline

20 January 2020

Primary endpoint
20 July 2021

20 July 2021

Quick facts

Lead sponsor	Crainio Ltda
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	40
Start date	20 January 2020
Primary completion	20 July 2021
Estimated completion	20 July 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

nICP

Conditions studied

Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
Intracranial Hypertension — all drugs for Intracranial Hypertension →

Sponsor

Crainio Ltda — full company profile →

Who can join

16 and older, any sex, with Traumatic Brain Injury or Intracranial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously. This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available. The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment. Features of the optical signals would be analysed offline. A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A pilot clinical study to estimate intracranial pressure utilising cerebral photoplethysmograms in traumatic brain injury patients.
Roldan M, Abay TY, Uff C, Kyriacou PA. · · 2024 · cited 3× · PMID 38409283 · DOI 10.1007/s00701-024-06002-4

Verify or expand the search:

Other recruiting trials for Traumatic Brain Injury

Currently open trials in the same condition.

NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07455136 — A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Mon · recruiting
NCT07404761 — Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments · NA · recruiting
NCT07230002 — Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in N · NA · recruiting

Other Crainio Ltda trials

Trials by the same sponsor.

NCT06453733 — Crainio Non-invasive ICP Monitor for TBI · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05632302 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Crainio Ltda
Last refreshed: 30 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05632302.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing