Autism Spectrum DisorderNCT06497218
Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
A study testing Blinklab diagnostic device in people with Autism Spectrum Disorder, run by Blinklab Limited at 1 site in Morocco.
Trial summary
Retrospective case-control study to assess the diagnostic accuracy in autism spectrum disorder (ASD) of a new smartphone-based platform designed to conduct neurometric evaluations by measuring facial and behavioural reflexes. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Blinklab diagnostic device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteMorocco
- Study dates
- 15 May 2023to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female individuals between the ages of 3 - 12 years old at the time of consent.
- Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
- Normal or corrected-to-normal vision with visual acuity sufficient to watch short videos.
- Hearing adequate to hear the auditory stimuli delivered via headphones.
Who cannot join
- Participants under 3 or over 12 years old.
- Severe hearing or visual impairment.
- Participants using medication that affects the nervous system (classified as ATC N0 medication, https://www.whocc.no).
Trial locations and contacts
1 site in 1 country.
Morocco1 site, 1 recruiting
- Recruiting
Mohammed VI National Center for the Disabled
Salé
Khalid Benhassan, MD
About this study
Retrospective case-control study to assess the diagnostic accuracy in autism spectrum disorder (ASD) of a new smartphone-based platform designed to conduct neurometric evaluations by measuring facial and behavioural reflexes.
Read the detailed description
This is a retrospective multi-centre case-control study to measure sensorimotor anomalies linked to autism spectrum disorder (ASD) to assess the diagnostic accuracy of smartphone-based neurobehavioral evaluations. The primary objective of the study is to evaluate diagnostic accuracy of the smartphone-based assessments compared to a formal clinical diagnosis using machine learning algorithms.
Neurobehavioral testing will be performed using BlinkLab, a smartphone-based platform. The tests include general measurement of spontaneous and stimulus-evoked postural, head, facial, and vocal responses along with specific neurometric tests, including the acoustically evoked eyelid startle reflex (ASR), and tests that involve the modulation of the ASR, including prepulse inhibition (PPI) and habituation (HAB). Children required to participate in two consecutive 15-minute tests. During the experiment, the children will watch an audio-normalized movie while the trials containing the auditory stimuli will be delivered via headphones. For each trial, computer vision algorithms will be used to track and record the position of the participant's facial landmarks over time. The study will compare responses in children with ASD who received a formal DSM-5 based diagnosis prior to study inclusion and neurotypical children that had no formal psychiatric diagnoses.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Blinklab diagnostic device
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinklab diagnostic deviceDiagnostic test
Blinklab is a non-invasive diagnostic device for Autism Spectrum Disorder
| Study group | Role | What they receive |
|---|---|---|
| Children formally diagnosed with Autism Spectrum Disorder | Experimental | Children aged between 3 and 12 years with Autism Spectrum Disorder who received a formal DSM-5 diagnosis will be tested with Blinklab smart phone based diagnostic tool Receives: Diagnostic Test: Blinklab diagnostic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Sensitivity
Measure of the proportion of children truly having ASD who are correctly identified by the device as Positive for ASD relative to a formal DSM-5 diagnosis
Measured: at baseline
Device Specificity
Measure of the proportion of children truly not having ASD (who had no prior psychiatric diagnosis) who are correctly identified by the device as Negative for ASD
Measured: at baseline
Secondary outcomes (11)
Screen Avoidance
The percentage of trials wherein the child was avoiding the smartphone's screen and camera
Measured: at baseline
Anteroposterior Postural Stability
The child's anteroposterior postural stability
Measured: at baseline
Head Rotations
The percentage of trials wherein the child was rotating their head
Measured: at baseline
Headphone Touches
The percentage of trials wherein the child was touching the headphone
Measured: at baseline
Mouth Opening
The size and timing of the child's mouth openings and closings
Measured: at baseline
Vocalizations
The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence
Measured: at baseline
Acoustic Startle Response (ASR)
Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children
Measured: at baseline
Long-term habituation (long-term HAB)
Levels of habituation of the ASR over the course of the 15-minute test
Measured: at baseline
Prepulse inhibition (PPI)
Reduction in the amplitude of the eyelid startle response due to prepulse stimuli
Measured: at baseline
Short-term habituation (short-term HAB)
Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses
Measured: at baseline
Anticipatory eye blinks (AEB)
The anticipatory eye blinks (AEB) in predefined observation windows (OW) containing an omitted pulse. AEB were responses that were not triggered by the startle stimulus itself but rather by the expectation of an upcoming startle stimulus
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start15 May 2023
- Primary completion16 Oct 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will undergo investigational diagnosis for ASD. Results will be compared to formal diagnosis by healthcare specialists.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blinklab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mohammed VI National Center for the Disabled, Salé, Morocco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497218
- Sponsor's protocol ID
- 13943
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boele HJ, Jung C, Sherry S, Roggeveen LEM, Dijkhuizen S, Ohman J, Abraham E, Uvarov A, Boele CP, Gultig K, Rasmussen A, Vinueza-Veloz MF, Medina JF, Koekkoek SKE, De Zeeuw CI, Wang SS. Accessible and reliable neurometric testing in humans using a smartphone platform. Sci Rep. 2023 Dec 18;13(1):22871. doi: 10.1038/s41598-023-49568-2.
PubMed 38129487
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
- ClinicalTrials.gov ID
- NCT06497218
- Acronym / sponsor ID
- 13943
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Blinklab LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Mohammed VI National Center for the Disabled, Salé, Morocco
- Study start
- 15 May 2023 (actual)
- Primary completion
- 16 Oct 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective case-control study to assess the diagnostic accuracy in autism spectrum disorder (ASD) of a new smartphone-based platform designed to conduct neurometric evaluations by measuring facial and behavioural reflexes.
Detailed description
This is a retrospective multi-centre case-control study to measure sensorimotor anomalies linked to autism spectrum disorder (ASD) to assess the diagnostic accuracy of smartphone-based neurobehavioral evaluations. The primary objective of the study is to evaluate diagnostic accuracy of the smartphone-based assessments compared to a formal clinical diagnosis using machine learning algorithms.
Neurobehavioral testing will be performed using BlinkLab, a smartphone-based platform. The tests include general measurement of spontaneous and stimulus-evoked postural, head, facial, and vocal responses along with specific neurometric tests, including the acoustically evoked eyelid startle reflex (ASR), and tests that involve the modulation of the ASR, including prepulse inhibition (PPI) and habituation (HAB). Children required to participate in two consecutive 15-minute tests. During the experiment, the children will watch an audio-normalized movie while the trials containing the auditory stimuli will be delivered via headphones. For each trial, computer vision algorithms will be used to track and record the position of the participant's facial landmarks over time. The study will compare responses in children with ASD who received a formal DSM-5 based diagnosis prior to study inclusion and neurotypical children that had no formal psychiatric diagnoses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will undergo investigational diagnosis for ASD. Results will be compared to formal diagnosis by healthcare specialists.
| Arm | Type | Receives |
|---|---|---|
| Children formally diagnosed with Autism Spectrum Disorder | Experimental | Diagnostic Test: Blinklab diagnostic deviceChildren aged between 3 and 12 years with Autism Spectrum Disorder who received a formal DSM-5 diagnosis will be tested with Blinklab smart phone based diagnostic tool |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female individuals between the ages of 3 - 12 years old at the time of consent.
- Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
- Normal or corrected-to-normal vision with visual acuity sufficient to watch short videos.
- Hearing adequate to hear the auditory stimuli delivered via headphones.
Key exclusion criteria (3 listed)
- Participants under 3 or over 12 years old.
- Severe hearing or visual impairment.
- Participants using medication that affects the nervous system (classified as ATC N0 medication, https://www.whocc.no).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blinklab diagnostic deviceBlinklab is a non-invasive diagnostic device for Autism Spectrum Disorder | Diagnostic test | Children formally diagnosed with Autism Spectrum Disorder |
Primary outcome
Device Sensitivity
Time frame: at baseline
Measure of the proportion of children truly having ASD who are correctly identified by the device as Positive for ASD relative to a formal DSM-5 diagnosis
Device Specificity
Time frame: at baseline
Measure of the proportion of children truly not having ASD (who had no prior psychiatric diagnosis) who are correctly identified by the device as Negative for ASD
11 secondary outcomes
Screen Avoidance
Time frame: at baseline
Anteroposterior Postural Stability
Time frame: at baseline
Head Rotations
Time frame: at baseline
Headphone Touches
Time frame: at baseline
Mouth Opening
Time frame: at baseline
Vocalizations
Time frame: at baseline
Acoustic Startle Response (ASR)
Time frame: at baseline
Long-term habituation (long-term HAB)
Time frame: at baseline
Prepulse inhibition (PPI)
Time frame: at baseline
Short-term habituation (short-term HAB)
Time frame: at baseline
Anticipatory eye blinks (AEB)
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 38129487Boele HJ, Jung C, Sherry S, Roggeveen LEM, Dijkhuizen S, Ohman J, Abraham E, Uvarov A, Boele CP, Gultig K, Rasmussen A, Vinueza-Veloz MF, Medina JF, Koekkoek SKE, De Zeeuw CI, Wang SS. Accessible and reliable neurometric testing in humans using a smartphone platform. Sci Rep. 2023 Dec 18;13(1):22871. doi: 10.1038/s41598-023-49568-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinklab diagnostic device in people with Autism Spectrum Disorder, run by Blinklab Limited at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henk-Jan Boele, MD (+31611132247, henkjan@blinklab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Sensitivity (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06497218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.