Measuring brain activity by in-ear electrodes in hospitalised patients
| ISRCTN | ISRCTN25897827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25897827 |
| IRAS number | 324099 |
| Secondary identifying numbers | IRAS 324099, CPMS 60286 |
- Submission date
- 07/02/2024
- Registration date
- 07/02/2024
- Last edited
- 12/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Clinical electroencephalography (EEG) is an important test in the care of many patients in hospital – from people who are mildly confused, or those seizures or having “funny turns”, to those who are completely unresponsive. Clinical EEG safely and without harm records “brain waves” (the electrical activity of the brain) from about 20 sensors, called electrodes, temporarily stuck to the scalp with glue or paste. A clinical EEG takes about 15 minutes to set up and 30 minutes to record.
By studying the brain waves recorded from an EEG, a specialist can try and work out what is happening in the brain to cause a patient’s problem. However, EEG is poorly available in hospitals, needing expensive equipment and specialists to record and interpret.
In this study the researchers are interested in making a new kind of EEG recording device which can simply record electrical brain activity from within the ear canal, and without the need for glue or paste. This could make EEG far more available and easier to use because such a device could be quickly and easily inserted without the need for expensive equipment, scalp electrodes, or specialist training.
However, to understand if such a future device is possible, the researchers first need to record “in-ear” EEG signals, i.e., via electrodes not placed on the scalp as normal, but rather placed in the ear canals using an 'ear plug' style electrode built into a soft ear plug. Then, at the same time, the researchers want to record standard clinical EEG from the scalp, and then later compare the two recordings.
Who can participate?
Any patient aged 18 years and over referred to an inpatient EEG
What does the study involve?
During the standard clinical EEG, the researchers will additionally record from the ear canals using a safe and harmless in-ear EEG electrode/sensor. The clinical EEG records from electrodes attached to the skull using glue or paste. The recordings are obtained by an “ear plug” device inserted into the ears at the same time. The in-ear electrodes are single-use only.
What are the possible benefits and risks of participating?
The researchers do not foresee any side effects or disadvantages to taking part in this study. They have used the same in-ear recording electrodes in many healthy human participants before and they have not reported any problems.
Although unlikely, is possible the in-ear EEG electrodes may cause minor discomfort, just as any ear plug or hearing aid around the ear might. If the patient reports or shows any pain or discomfort, the researchers will remove the in-ear EEG electrode and stop the in-ear EEG recording, but the clinical EEG will carry on as planned, so taking part in the study will not have any negative effects on clinical care.
The study will not have any direct benefit. It is hoped that the information obtained might lead to the development of an in-ear EEG device, which in turn can improve the treatment of people who would benefit from EEG recordings, such as those with impaired consciousness, seizures, and other brain disorders.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
January 2023 to June 2025
Who is funding the study?
UK Research and Innovation
Who is the main contact?
Dr Gregory Scott, gregory.scott99@imperial.ac.uk
Contact information
Public, Scientific, Principal Investigator
UK Dementia Research Institute Care Research and Technology Centre
Floor 9 Sir Michael Uren Hub
Imperial College London, White City Campus
86 Wood Lane
London
W12 0BZ
United Kingdom
 ORCID ID |
0000-0001-8063-5871 |
|---|---|
| Phone | +44 (0)20 7589 5111 |
| gregory.scott99@imperial.ac.uk |
Study information
| Study design | Observational pilot/feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A study of in-ear electroencephalography signals additionally recorded in hospitalised patients already undergoing standard clinical electroencephalography |
| Study objectives | The primary objective of this pilot/feasibility study is to explore whether the electroencephalography (EEG) signals recorded from within the ear canals of hospitalised patients provide clinically useful information compared to standard clinical EEG. |
| Ethics approval(s) |
Approved 02/11/2023, North West - Greater Manchester South Research Ethics Committee (Health Research Authority, Redman Place, Stratford, E20 1JQ, United Kingdom; +44 (0)207 104 8014; gmsouth.rec@hra.nhs.uk), ref: 23/NW/0313 |
| Health condition(s) or problem(s) studied | Patients undergoing inpatient EEG in a hospital |
| Intervention | Current interventions as of 12/12/2024: In hospitalised patients for whom standard clinical EEG is already being performed, i.e., as part of their routine care, the researchers will additionally record EEG from the ear canals using ‘ear plug’ like electrodes. Previous interventions: In 30 hospitalised patients for whom standard clinical EEG is already being performed, i.e., as part of their routine care, the researchers will additionally record EEG from the ear canals using ‘ear plug’ like electrodes. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | In-ear EEG electrodes |
| Primary outcome measure | Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 3 months |
| Secondary outcome measures | This is a pilot/feasibility study. The study is partly motivated to determine the best outcome measures for this kind of work. One outcome measure will be the Cohen’s kappa, a measure of agreement between a clinical physiologist rating of normal/abnormality of the EEG (factoring out agreement due to chance), determined from (1) the in-ear EEG signal and (2) the standard clinical EEG, in the same patients (measured at a single visit). |
| Overall study start date | 01/01/2023 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged ≥18 years old 2. Undergoing an in-patient clinical EEG as part of routine care 3. In any patients who lack the capacity to consent: the involvement of the patient's consultee |
| Key exclusion criteria | 1. Suspected or proven base of skull fracture, or any other contraindication to insertion of material into either ear canal e.g. ear infection 2. Lacking the capacity to consent and no available consultee |
| Date of first enrolment | 08/01/2024 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W6 8RF
United Kingdom
Chalfont St. Peter
Gerrards Cross
SL9 0RJ
United Kingdom
Sponsor information
University/education
Room 215, Level 2
Medical School Building
Norfolk Place
London
W21PG
England
United Kingdom
| Phone | +44 (0)2075949459 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
12/12/2024: The following changes were made:
1. The study design was changed from a "Single-centre observational pilot/feasibility study".
2. The overall study end date was changed from 30/04/2024 to 30/06/2025.
3. The National Hospital for Neurology and Neurosurgery, Chalfont was added as a study participating centre.
04/03/2024: Internal review.
07/02/2024: Study's existence confirmed by the North West - Greater Manchester South Research Ethics Committee.
