Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder
Brief summary
The purpose of this study is to develop an Auditory Brainstem Response (ABR) based neurological screening method to detect increased risk for Autism Spectrum Disorders (ASD) and other neurological conditions in newborns.
Detailed description
In the proposed study, a screening method for neurological deficits, with an emphasis on its application to ASD, will be developed and its feasibility demonstrated. The proposed method will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to determine peak latency and amplitude differences in children with ASD compared to non-ASD. Similarly to newborn hearing screening, the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation.
Interventions
No Intervention Provided
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Intelligent Hearing Systems
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
42 Months to 54 Months
Healthy volunteers
Yes
Inclusion criteria
* Children with autism spectrum disorder diagnosis * Normally developing age- and gender-matched controls
Exclusion criteria
* Permanent or temporary hearing loss at the time of testing. * Craniofacial abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ABR Peak V Latency | One Week | Auditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Autism Spectrum Disorders Group Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old
No Intervention Provided: No Intervention Provided | 25 |
| Normal Control Group Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old
No Intervention Provided: No Intervention Provided | 56 |
| Total | 81 |
Baseline characteristics
| Characteristic | Normal Control Group | Total | Autism Spectrum Disorders Group |
|---|---|---|---|
| Age, Categorical <=18 years | 56 Participants | 81 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 47.3 months STANDARD_DEVIATION 17.1 | 49.1 months STANDARD_DEVIATION 16.4 | 53.0 months STANDARD_DEVIATION 14.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) White | 40 Participants | 60 Participants | 20 Participants |
| Region of Enrollment United States | 56 participants | 81 participants | 25 participants |
| Sex: Female, Male Female | 28 Participants | 34 Participants | 6 Participants |
| Sex: Female, Male Male | 28 Participants | 47 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 37 |
| other Total, other adverse events | 0 / 14 | 0 / 37 |
| serious Total, serious adverse events | 0 / 14 | 0 / 37 |
Outcome results
Primary
ABR Peak V Latency
Auditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans.
Time frame: One Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Autism Spectrum Disorders Group | ABR Peak V Latency | Peak V Latency at 39.3 Hz Rate | 6.29 ms | Standard Deviation 0.36 |
| Autism Spectrum Disorders Group | ABR Peak V Latency | Peak V Latency at 195.31 Hz Rate | 7.07 ms | Standard Deviation 0.31 |
| Autism Spectrum Disorders Group | ABR Peak V Latency | Peak V Latency at 58.59 Hz Rate | 6.48 ms | Standard Deviation 0.25 |
| Autism Spectrum Disorders Group | ABR Peak V Latency | Peak V Latency at 234.38 Hz Rate | 7.45 ms | Standard Deviation 0.58 |
| Autism Spectrum Disorders Group | ABR Peak V Latency | Peak V Latency at 19.3 Hz Rate | 6 ms | Standard Deviation 0.27 |
| Normal Control Group | ABR Peak V Latency | Peak V Latency at 234.38 Hz Rate | 7.28 ms | Standard Deviation 0.32 |
| Normal Control Group | ABR Peak V Latency | Peak V Latency at 19.3 Hz Rate | 5.8 ms | Standard Deviation 0.16 |
| Normal Control Group | ABR Peak V Latency | Peak V Latency at 39.3 Hz Rate | 5.99 ms | Standard Deviation 0.16 |
| Normal Control Group | ABR Peak V Latency | Peak V Latency at 58.59 Hz Rate | 6.26 ms | Standard Deviation 0.21 |
| Normal Control Group | ABR Peak V Latency | Peak V Latency at 195.31 Hz Rate | 6.89 ms | Standard Deviation 0.25 |