Non-invasive measurement of cerebral energy status: an opportunity to target neuroprotection in brain injury

ISRCTN	ISRCTN84669284
DOI	https://doi.org/10.1186/ISRCTN84669284
Secondary identifying numbers	5789

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Martin Smith
Scientific

National Hospital for Neurology & Neurosurgery
Box 30
London
WC1N 3BG
United Kingdom

Study design	Single centre non-randomised process of care trial
Primary study design	Observational
Secondary study design	Single-centre
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study acronym	Non-invasive measurement of cerebral energy status
Study objectives	We will use a combination of near infrared spectroscopy systems to assess non-invasively cerebral oxygenation, perfusion and cellular metabolic status in healthy volunteers and critically brain injured adults in order to monitor and quantify cerebral ischaemia in the latter. Specifically we will non-invasively measure changes in cell energy status by monitoring concentration changes in cytochrome oxidase (ox-CCO) using a novel hybrid optical spectroscopy system optimised for the measurement of ox-CCO in adults.
Ethics approval(s)	MREC approved (ref: 04/Q0512/67)
Health condition(s) or problem(s) studied	Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders
Intervention	Volunteer studies: Hyperoxia, hypoxia, hypercapnea and hypocapnea Patient studies: NIRS-derived changes in cerebral oxygenation, haemodynamics and oxidised cytochorme c oxidase concentrations, and cerebral microdialysis-derived markers of ischaemia (lactate:pyruvate ratio and glucose). Study entry: registration only
Intervention type	Other
Primary outcome measure	Infrared specotrscopy
Secondary outcome measures	Estimated cerebal oxygen delivery
Overall study start date	01/01/2006
Completion date	31/12/2011

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Planned sample size: 170
Key inclusion criteria	1. Healthy volunteers and patients with severe traumatic brain injury 2. Male and female, lower age limit of 18 years
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2011

National Hospital for Neurology & Neurosurgery

London
WC1N 3BG
United Kingdom

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Directorate
250 Euston Road
London
NW1 2PG
England
United Kingdom

Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Research council

Engineering and Physical Sciences Research Council (EPSRC) (UK)
Government organisation / National government

Alternative name(s): UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
Location: United Kingdom

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No