Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401778296247 Date of Approval: 12/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Usability and efficacy of an affordable, smartphone-connected EEG device to bridge the global gap in epilepsy diagnosis
Official scientific title Usability and efficacy of an affordable, smartphone-connected EEG device to bridge the global gap in epilepsy diagnosis
Brief summary describing the background and objectives of the trial Founded by a team of neurologists and data scientists, BrainCapture has developed an affordable, easy-to-use portable electroencephalography (EEG) device that yields essential electrodiagnostics for patients with seizures and suspected epilepsy in settings with limited access to experts. The device consists of an amplifier / electrode cap for recording EEGs, a proprietary Android-based smartphone application that guides a non-expert through the recording process, and a cloud-based telemedicine solution that allows secure transfer of patient data to be read by a remote expert and communication between experts and the clinicians at the point of care. The device has been approved for marketing and sale in Kenya and will soon receive medical CE-marking in the European Union. It has been tested in a Sub-Saharan African setting with positive results (the Republic of Guinea; Williams et al., 2019). In this project, we aim to assess the usability and efficacy of the device by evaluating the quality of recordings completed by non-expert health workers. Phase I will focus on the usability of and proof of concept for the device; Phase II will assess efficacy of the device for patients in whom EEG is clinically indicated, with the goal of providing clinically useful diagnostic information for patients with suspected epilepsy.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BrainCapture1 One EEG recording using BrainCapture's BC-1 device. This is an EEG diagnostic that will take approximately 30 minutes. A non-expert medical staff member, after a short (less than four hours) training on EEG procedure, will follow the instructions from the BrainCapture1 application to record a 30-minute clinical EEG on participants using the BrainCapture 1 device and a 27-channel electrode cap. The EEG will include all standard EEG elements (calibration, hyperventilation, if indicated); no photic stimulation will be utilised. 200
Control Group AGK EEG Lan One standard clinical EEG evaluation. 30 mins EEG will be recorded using a standard 19-channel Nihon Khoden device operated by an EEG technologist with at least three years of experience. 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: 1) presenting to Aga Khan with a clinical suspicion of epilepsy 2) Ages 2 to 80 years; 3) Willingness to undergo two separate EEG exams; 4) Ability to provide informed consent (either self or as legal representative of subject) or assent for minors Exclusion criteria: 1) Any other diagnosis that can better explain the symptoms, making the diagnosis of epilepsy unlikely; unable to undergo the study procedures; 2) Age <2 years old due to lack of electrode cap for small head size; 3) Health or practical issues impeding data collection as determined at the discretion of the examiner (e.g., hairstyle that precludes electrode contact with scalp) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 2 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/02/2023 Aga Khan University Hospital ERC
Ethics Committee Address
Street address City Postal code Country
3 Parklands Ave Nairobi 2800 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Finding Epileptiform discharges post scan
Secondary Outcome High quality scan during evaluation of scan
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital Nairobi 3 Parklands Ave Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
BrainCapture ApS Elektrovej 331 Kongens Lyngby 2800 Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BrainCapture Elektrovej 331 Copenhagen 2100 Denmark Company
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dilraj Sokhi dilraj.sokhi@aku.edu 254710559541 3rd Parklands Ave
City Postal code Country Position/Affiliation
Nairobi Kenya Doctor at Aga Khan
Role Name Email Phone Street address
Public Enquiries Paul Loomis p.loomis@braincapture.dk 254799920707 2.2 Kitisuru rd
City Postal code Country Position/Affiliation
Nairobi Kenya CCO
Role Name Email Phone Street address
Scientific Enquiries Dilraj Sokhi dilraj.sokhi@aku.edu 254710559541 3rd parklands ave
City Postal code Country Position/Affiliation
nairobi Kenya Aga Khan Dr.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Confidential information will not be shared. If participants are interested, there will be public forums in the community to discuss our results and these will be announced. Names or other identifying information will not be included in publications or with EEG files sent to interpreters. All identifying information will be removed when EEGs are uploaded for interpretation. Anonymized EEG files may be used by the study sponsor for other research that could contribute to better understanding of epilepsy in this population (e.g., machine learning to automate EEG interpretation and increase access to care). Study Protocol By end of study Any interested
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information