Trial Outcomes & Findings for BCI (Brain Computer Interface) Intervention in Autism (NCT NCT02445625)

Last Updated: 2019-02-18

Results Overview

Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT\_NoFace with no previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

16 weeks, and 6 months after intervention

Results posted on

2019-02-18

Participant Flow

A total of 15 (plus 3 in case of drop outs) participants will be recruited. We expect to recruit one subject each three weeks. We recruited the first participant on the second semester of 2015 and the study last up to 82 weeks (including follow-up).

Participant milestones

Participant milestones
Measure	High Functioning ASD Adolescents and Adults The eligible patients for the study should be high functioning ASD adolescents and adults. These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration. Positive diagnostic results for ASD in: * Autism Diagnostic Interview-Revised; * Autism Diagnostic Observation Schedule; * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BCI (Brain Computer Interface) Intervention in Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Functioning ASD Adolescents and Adults n=15 Participants The eligible patients for the study should be high functioning ASD adolescents and adults. These participants should also meet all the following inclusion criteria and none of the exclusion criteria. All queries about patient eligibility should be directed to Susana Mouga before registration. Positive diagnostic results for ASD in: * Autism Diagnostic Interview-Revised; * Autism Diagnostic Observation Schedule; * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Age, Continuous	22.333 years STANDARD_DEVIATION 5.5 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Portugal	15 participants n=93 Participants
JAAT_NoFace	16.33 Correct Fixations STANDARD_DEVIATION 9.36 • n=93 Participants
JAAT_Face	10.67 Correct Fixations STANDARD_DEVIATION 9.35 • n=93 Participants
ATEC - Autism Treatment Evaluation Checklist	35.57 score on a scale STANDARD_DEVIATION 12.53 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale VABS_COM_baseline	68.27 units on a scale STANDARD_DEVIATION 21.53 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale VABS_DLS_baseline	77.53 units on a scale STANDARD_DEVIATION 14.05 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale VABS_SOC_baseline	65.80 units on a scale STANDARD_DEVIATION 16.79 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale VABS_ABC_baseline	65.73 units on a scale STANDARD_DEVIATION 15.56 • n=93 Participants

PRIMARY outcome

Timeframe: 16 weeks, and 6 months after intervention

Outcome measures

Outcome measures
Measure	High Functioning ASD Adolescents and Adults n=15 Participants Positive diagnostic results for ASD in: * Autism Diagnostic Interview-Revised; * Autism Diagnostic Observation Schedule; * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
JAAT_NoFace 16 weeks	13.73 Correct Fixations Standard Deviation 8.19
JAAT_NoFace 6 months after intervention	15.00 Correct Fixations Standard Deviation 10.02

PRIMARY outcome

Timeframe: 16 weeks, and 6 months after intervention

Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT\_NoFace with previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.

Outcome measures

Outcome measures
Measure	High Functioning ASD Adolescents and Adults n=15 Participants Positive diagnostic results for ASD in: * Autism Diagnostic Interview-Revised; * Autism Diagnostic Observation Schedule; * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
JAAT_Face 16 weeks	7.80 Correct Fixations Standard Deviation 8.77
JAAT_Face 6 months after intervention	7.53 Correct Fixations Standard Deviation 8.11

SECONDARY outcome

Timeframe: 16 weeks, and Follow-Up (6 months after intervention)

Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179. The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems.

Outcome measures

Outcome measures
Measure	High Functioning ASD Adolescents and Adults n=15 Participants Positive diagnostic results for ASD in: * Autism Diagnostic Interview-Revised; * Autism Diagnostic Observation Schedule; * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
ATEC - Autism Treatment Evaluation Checklist 16 weeks	24.29 score on a scale Standard Deviation 12.90
ATEC - Autism Treatment Evaluation Checklist Follow-up (6 months after intervention)	18.43 score on a scale Standard Deviation 11.77

SECONDARY outcome

Timeframe: 16 weeks, and Follow-Up (6 months after intervention)

The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC. The Adaptive Behaviour Composite ABC (total score) is the sum of the raw scores from the main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior. Sparrow, S., Balla, D., \& Cicchetti, D. (1984). Vineland Adaptative Behaviour Scales: Interview edition, Survey form. Circle Pines, MN: American Guidance Service.

Outcome measures

Outcome measures
Measure	High Functioning ASD Adolescents and Adults n=15 Participants Positive diagnostic results for ASD in: * Autism Diagnostic Interview-Revised; * Autism Diagnostic Observation Schedule; * The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
VABS - Vineland Adaptive Behaviour Scale VABS_COM_16 weeks	71.33 units on a scale Standard Deviation 21.62
VABS - Vineland Adaptive Behaviour Scale VABS_COM_Follow-up (6 months after intervention)	73.14 units on a scale Standard Deviation 17.29
VABS - Vineland Adaptive Behaviour Scale VABS_DLS_16 weeks	81.60 units on a scale Standard Deviation 14.46
VABS - Vineland Adaptive Behaviour Scale VABS_DLS_Follow-up (6 months after intervention)	86.29 units on a scale Standard Deviation 14.02
VABS - Vineland Adaptive Behaviour Scale VABS_SOC_16 weeks	67.67 units on a scale Standard Deviation 16.18
VABS - Vineland Adaptive Behaviour Scale VABS_SOC_Follow-up (6 months after intervention)	71.14 units on a scale Standard Deviation 16.11
VABS - Vineland Adaptive Behaviour Scale VABS_ABC_16 weeks	69.00 units on a scale Standard Deviation 15.20
VABS - Vineland Adaptive Behaviour Scale VABS_ABC_Follow-up (6 months after intervention)	72.00 units on a scale Standard Deviation 13.65

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks plus 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

21-item measure of clinical depression

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 16 weeks

Covers: strategies; general experience of the process; adverse effects;

Outcome measures

Outcome data not reported

Adverse Events

High Functioning ASD Adolescents and Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Miguel Castelo-Branco

University of Coimbra

Phone: +351239790000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place