Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03882671




Registration number
NCT03882671
Ethics application status
Date submitted
11/03/2019
Date registered
20/03/2019
Date last updated
14/04/2023

Titles & IDs
Public title
Development of a Minimally Invasive Seizure Gauge
Scientific title
Development of a Minimally Invasive Seizure Gauge
Secondary ID [1] 0 0
HREC042_18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - EpiTel Epilog
Treatment: Devices - Empatica E4
Treatment: Devices - GENEActiv

Experimental: Monitoring Device - Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv


Treatment: Devices: EpiTel Epilog
EEG recording device

Treatment: Devices: Empatica E4
PPG, sweat level, temperature and accelerometry recording device

Treatment: Devices: GENEActiv
Temperature, light level and accelerometry recording device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors
Timepoint [1] 0 0
2-7 days approximately
Primary outcome [2] 0 0
Wearable Sensors Comfort Assessment
Timepoint [2] 0 0
2-7 days approximately
Primary outcome [3] 0 0
Seizure Detection and Prediction using Multimodal Physiological Data
Timepoint [3] 0 0
2-7 days approximately

Eligibility
Key inclusion criteria
- Patients with epilepsy undergoing scalp EEG for clinical care, or an implanted device
capable of monitoring brain activity and identifying seizures

- Patients of age 18 or above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cognitive or psychiatric condition rendering patient unable to cooperate with data
collection, or manage and recharge smart watch and tablet computer devices.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Seer Medical - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Seer Medical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The researchers are trying to assess changes in physiological signals before and during
seizures.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03882671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dean R Freestone, PhD BEng
Address 0 0
CEO
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03882671