Real-time functional brain imaging using Electrical Impedance Tomography of Evoked Responses

ISRCTN ISRCTN93596854
DOI https://doi.org/10.1186/ISRCTN93596854
Secondary identifying numbers 077724; NRES:07/H1003/H145/CMFT:9644
Submission date
11/11/2009
Registration date
12/11/2009
Last edited
27/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hugh McCann
Scientific

School of Electrical & Electronic Engineering
University of Manchester
PO Box 88
Sackville Street
Manchester
M60 1QD
United Kingdom

Phone +44 (0)161 306 4791
Email h.mccann@manchester.ac.uk

Study information

Study designTwo stages: 1. Volunteer safety trial 2. Patient randomised blinded crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleReal-time functional brain imaging using Electrical Impedance Tomography of Evoked Responses: two stage volunteer safety and patient randomised crossover trial
Study acronymfEITER
Study objectivesFunctional brain imaging using positron emission tomography has shown that general anaesthesia reduces brain function in a dose-related manner. It is hypothesised that fEITER will derive similar images of human brain function arising from the normal changes in synaptic impedance that occur during cerebral processing of sensory information, but much faster than existing scanning methods and with a suitcase-sized device. We expect fEITER to visualise the reduction in cerebral sensory processing during anaesthesia, and this study will allow the preparation of a dose-response curve indicating the level of anaesthesia with fEITER. Deep surgical anaesthesia has a maximal effect on reducing brain metabolism, so such measurement will permit calibration of the 100% level for sensitivity of fEITER. The null hypothesis is that fEITER will visualise no effect of anaesthesia on brain function.

As of 05/10/2010 the initial end date of this trial has been extended by the funders, the Wellcome Trust. The initial end date at time of registration was 30/09/2010. Stage 1 healthy volunteers is completed (n = 20) and stage 2 patients is recruiting with n = 4 to date.
Ethics approval(s)South Manchester Research Ethics Committee approved on the 30th January 2008 (ref: 07/H1003/H145). Confirmation of continued favourable opinion was given on 11th August 2009.
Health condition(s) or problem(s) studiedBrain function during anaesthesia
InterventionFor both stages 1 and 2, 32 electroencephalogram (EEG) electrodes will be affixed to the scalp at the beginning of the trial (10 minutes). For stage 1 (healthy volunteers), a one-hour trial of fEITER will proceed, comprising sequential one-minute presentations of auditory (click and tone) and visual (flash) sensory stimuli presented in a random sequence during fEITER tomograpic measurements of brain function in response to the sensory stimuli. For stage 2 (anaesthetised patients), an awake tolerance test of two, one-minute presentations of visual and auditory stimuli will be tested with fEITER (control) and then repeated, sequential one-minute tests of fEITER will be conducted during anaesthesia and surgery. The randomisation and crossover will be in the depth of anaesthesia used (concentration of anaesthetic agent) within normal clinical ranges. Depth of anaesthesia will be assessed before and after each one-minute fEITER test using a commercial depth of anaesthesia monitor (Bispectral Index). The total duration for stage 2 will be the length of surgery, which is variable.

Please note that as of 26/05/10 the end date of this trial has been extended from 30/06/10 to 30/09/10
Intervention typeProcedure/Surgery
Primary outcome measureProduction of functional brain images that discriminate between different depths of anaesthesia and awake subjects, assessed continuously during the fEITER trial using 1-minute epochs of cerebral conductance data obtained every 10 ms, and determined by off-line analysis, including 3D functional brain image reconstruction, after the trial.
Secondary outcome measuresNo secondary outcome measures
Overall study start date16/11/2009
Completion date30/04/2011

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20 healthy volunteers; 20 patients
Key inclusion criteriaStage 1:
1. Healthy volunteers
2. Aged 18 to 80 years, gender: female, trans or male

Stage 2:
1. American Society of Anaesthesiologists (ASA) grade I - II
2. Adult patients aged 18 to 80 years, gender: female, trans or male
3. Scheduled for elective surgery under routine general anaesthesia
Key exclusion criteriaStages 1 and 2:
History of epilepsy or neurological impairment
Date of first enrolment16/11/2009
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Electrical & Electronic Engineering
Manchester
M60 1QD
United Kingdom

Sponsor information

University of Manchester (UK)
University/education

Oxford Road
Manchester
M13 9WL
England
United Kingdom

Phone +44 (0)161 276 8582
Email chris.pomfrett@manchester.ac.uk
Website http://www.manchester.ac.uk
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Charity

Wellcome Trust (UK) - University Translation Award (grant ref: 077724)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results: 01/06/2011 Yes No

Editorial Notes

27/04/2016: Publication reference added