Trial Outcomes & Findings for Rt-fMRI NF Intervention Study in ASD (NCT NCT02440451)

Last Updated: 2019-02-20

Results Overview

The Emotion Hexagon test represents the primary outcome measure. The assessment based on this test will be performed before (baseline), after the intervention - endpoint 1 (at 8 weeks) and at the 6 months follow-up. The Emotion Hexagon test uses stimuli of graded difficulty, created using computer image manipulation techniques (morphing is used to modify photographs from the Ekman and Friesen (1976) series, creating examples that lie close to or more distant from the prototype expression). The 120 test trials with unambiguous stimuli (4 pictures for each of the 6 emotions across the 5 test blocks) can be used to derive an overall (total) score out of a possible maximum of 120 expressions correctly recognized.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

8 weeks (Endpoint 1) plus 6 months follow-up

Results posted on

2019-02-20

Participant Flow

The participants, mainly recruited on a collaborative effort between the Pediatrics Hospital of Coimbra and local ASD associations, were invited for an fMRI neurofeedback feasibility clinical trial study in ASD. All participants had normal or corrected to normal vision. ). The first participant was recruited in February 2016.

There was no significant events after participant enrollment, before group assignment.

Participant milestones

Participant milestones
Measure	Neurofeedback Using BCI 16 (13 + 3 in case of dropoffs) ASD subjects Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rt-fMRI NF Intervention Study in ASD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neurofeedback Using BCI n=15 Participants 16 (13 + 3 in case of dropoffs) ASD subjects Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
Age, Continuous	19.92 years 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
FEEST - Facial Expression of Emotion: Stimuli and Tests	98 units on a scale STANDARD_DEVIATION 19.30 • n=93 Participants
ATEC - Autism Treatment Evaluation Checklist	36.6 units on a scale STANDARD_DEVIATION 13.94 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale Baseline [VABS COM]	70.6 units on a scale STANDARD_DEVIATION 15.65 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale Baseline [VABS DLS]	74 units on a scale STANDARD_DEVIATION 17.15 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale Baseline [VABS SOC]	63.4 units on a scale STANDARD_DEVIATION 14.21 • n=93 Participants
VABS - Vineland Adaptive Behaviour Scale Baseline [VABS ABC]	63.4 units on a scale STANDARD_DEVIATION 13.52 • n=93 Participants

PRIMARY outcome

Timeframe: 8 weeks (Endpoint 1) plus 6 months follow-up

Outcome measures

Outcome measures
Measure	Neurofeedback Using BCI n=15 Participants 16 (13 + 3 in case of dropoffs) ASD subjects Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
FEEST - Facial Expression of Emotion: Stimuli and Tests 6 months follow-up	100.79 units on a scale Standard Deviation 20.01
FEEST - Facial Expression of Emotion: Stimuli and Tests Endpoint 1	100.27 units on a scale Standard Deviation 19.29

SECONDARY outcome

Timeframe: 8 weeks (Endpoint 1) plus 6 months follow up

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	Neurofeedback Using BCI n=15 Participants 16 (13 + 3 in case of dropoffs) ASD subjects Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
ATEC - Autism Treatment Evaluation Checklist Endpoint 1	32 units on a scale Standard Deviation 14.66
ATEC - Autism Treatment Evaluation Checklist 6 months follow-up	19.64 units on a scale Standard Deviation 8.13

SECONDARY outcome

Timeframe: 8 weeks (Endpoint 1) plus 6 months follow-up

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 (all reported here in terms of standard scores as described in the VABS manual, i.e. mean 100 and standard deviation 15). The Adaptive Behaviour Composite ABC (total score, also reported here) is the sum of the raw scores from the three main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior.

Outcome measures

Outcome measures
Measure	Neurofeedback Using BCI n=15 Participants 16 (13 + 3 in case of dropoffs) ASD subjects Neurofeedback (BCI using neuroimaging): This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
VABS - Vineland Adaptive Behaviour Scale Endpoint 1 [VABS COM]	74.87 units on a scale Standard Deviation 14.95
VABS - Vineland Adaptive Behaviour Scale 6 months follow-up [VABS COM]	79.79 units on a scale Standard Deviation 13.69
VABS - Vineland Adaptive Behaviour Scale 6 months follow-up [VABS DLS]	83.14 units on a scale Standard Deviation 17.00
VABS - Vineland Adaptive Behaviour Scale Endpoint 1 [VABS DLS]	76.93 units on a scale Standard Deviation 16.46
VABS - Vineland Adaptive Behaviour Scale Endpoint 1 [VABS SOC]	66.73 units on a scale Standard Deviation 16.42
VABS - Vineland Adaptive Behaviour Scale Endpoint 1 [VABS ABC]	67.13 units on a scale Standard Deviation 15.22
VABS - Vineland Adaptive Behaviour Scale 6 months follow-up [VABS SOC]	71.43 units on a scale Standard Deviation 15.36
VABS - Vineland Adaptive Behaviour Scale 6 months follow-up [VABS ABC]	73.57 units on a scale Standard Deviation 13.67

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