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Trial record 1 of 3 for:    brain computer interface autism
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BCI (Brain Computer Interface) Intervention in Autism (BCIAUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02445625
Recruitment Status : Completed
First Posted : May 15, 2015
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Miguel Castelo-Branco, University of Coimbra

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autism Spectrum Disorder
Intervention Device: BCI to train joint attention in ASD
Enrollment 15
Recruitment Details 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).
Pre-assignment Details  
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description

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.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description

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 Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
22.333  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
15
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
15
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Portugal Number Analyzed 15 participants
15
JAAT_NoFace   [1] 
Mean (Standard Deviation)
Unit of measure:  Correct Fixations
Number Analyzed 15 participants
16.33  (9.36)
[1]
Measure Description: 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.
JAAT_Face   [1] 
Mean (Standard Deviation)
Unit of measure:  Correct Fixations
Number Analyzed 15 participants
10.67  (9.35)
[1]
Measure Description: 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.
ATEC - Autism Treatment Evaluation Checklist   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 15 participants
35.57  (12.53)
[1]
Measure Description:

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.

VABS - Vineland Adaptive Behaviour Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants
VABS_COM_baseline 68.27  (21.53)
VABS_DLS_baseline 77.53  (14.05)
VABS_SOC_baseline 65.80  (16.79)
VABS_ABC_baseline 65.73  (15.56)
[1]
Measure Description: 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.
1.Primary Outcome
Title JAAT_NoFace
Hide Description 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.
Time Frame 16 weeks, and 6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description:

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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Correct Fixations
16 weeks 13.73  (8.19)
6 months after intervention 15.00  (10.02)
2.Primary Outcome
Title JAAT_Face
Hide Description 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.
Time Frame 16 weeks, and 6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description:

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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Correct Fixations
16 weeks 7.80  (8.77)
6 months after intervention 7.53  (8.11)
3.Secondary Outcome
Title ATEC - Autism Treatment Evaluation Checklist
Hide Description

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.

Time Frame 16 weeks, and Follow-Up (6 months after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description:

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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
16 weeks 24.29  (12.90)
Follow-up (6 months after intervention) 18.43  (11.77)
4.Secondary Outcome
Title VABS - Vineland Adaptive Behaviour Scale
Hide Description 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.
Time Frame 16 weeks, and Follow-Up (6 months after intervention)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description:

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 Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
VABS_COM_16 weeks 71.33  (21.62)
VABS_COM_Follow-up (6 months after intervention) 73.14  (17.29)
VABS_DLS_16 weeks 81.60  (14.46)
VABS_DLS_Follow-up (6 months after intervention) 86.29  (14.02)
VABS_SOC_16 weeks 67.67  (16.18)
VABS_SOC_Follow-up (6 months after intervention) 71.14  (16.11)
VABS_ABC_16 weeks 69.00  (15.20)
VABS_ABC_Follow-up (6 months after intervention) 72.00  (13.65)
5.Other Pre-specified Outcome
Title POMS - Profile of Mood States
Hide Description [Not Specified]
Time Frame 16 weeks plus 6 months
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title HADS - Hospital Anxiety & Depression Scale
Hide Description 21-item measure of clinical depression
Time Frame 16 weeks
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Debriefing Interview Questionnaire
Hide Description Covers: strategies; general experience of the process; adverse effects;
Time Frame 16 weeks
Outcome Measure Data Not Reported
Time Frame 10 months (from baseline until 6 months follow-up assessment)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Functioning ASD Adolescents and Adults
Hide Arm/Group Description

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.
All-Cause Mortality
High Functioning ASD Adolescents and Adults
Affected / at Risk (%)
Total   0/15 (0.00%) 
Hide Serious Adverse Events
High Functioning ASD Adolescents and Adults
Affected / at Risk (%)
Total   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Functioning ASD Adolescents and Adults
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Miguel Castelo-Branco
Organization: University of Coimbra
Phone: +351239790000
EMail: mcbranco@fmed.uc.pt
Layout table for additonal information
Responsible Party: Miguel Castelo-Branco, University of Coimbra
ClinicalTrials.gov Identifier: NCT02445625    
Other Study ID Numbers: IBILI-VB-2015-01
First Submitted: April 24, 2015
First Posted: May 15, 2015
Results First Submitted: October 11, 2018
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019