fNIRS Neurofeedback Training Using Virtual Reality in Children With ADHD

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: ADHD

Treatments: Behavioral: fNIRS Neurofeedback-VR Training; Behavioral: Computerized Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05906485

EA200247

Details and patient eligibility

About

The study aims to explore the effectiveness of neurofeedback training on improving attention and inhibitory control of children with attention-deficit/hyperactivity disorder (ADHD) in Hong Kong. This study will contribute to the current understanding of the alternative treatments for ADHD, and hopefully help to mobilize more resources to support children with ADHD. The programme includes the following components:

Participants will be randomly assigned to the neurofeedback training group (with virtual reality [VR] technology applied), the computerized cognitive training group, or the waitlist control group. All participants will complete a total of 16 training sessions in 8 weeks (twice a week), and each session will last around 35 to 60 mins.

To investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to the intervention (i.e., Time 1), immediately after the 8-week training (i.e., Time 2), and 2 months after the training (i.e., Time 3, a 2-month follow up). The assessment will take around 1 hour and it will be conducted at the laboratory at the University of Hong Kong. Also, parents and teachers will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 timepoints.

Enrollment: 138 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 7- 12
• Clinical diagnosis of ADHD
• Significant teacher- or parent-reported attention problems during screening

Exclusion criteria

• IQ under 70, as measured on Raven's Progressive Matrices
• Hearing, visual, or physical impairments that might hinder participation in the training and assessment activities
• Clinical diagnosis and suspected cases of Autism Spectrum Disorder (ASD)
• Prior or current participation in NFT
• Current participation in a psychotherapeutic treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

138 participants in 3 patient groups

Experimental Group: fNIRS Neurofeedback-VR Training Group

Experimental group

Description:

The experimental group will receive 16 sessions of training, 1 hour each, conducted twice per week over a period of 8 weeks. A classroom setting will be stimulated using VR and participants will be asked to complete some academic-related tasks during the stimulated lessons. The sensor on the neurofeedback device worn by the participants will detect changes in the blood oxy-hemoglobin level in brain cortical tissue and feedback to the participants via visual images or auditory sounds from the computer. Through practice, participants will learn to manipulate their attention, presumably by altering brain activities.

Treatment:

Behavioral: fNIRS Neurofeedback-VR Training

Active Control Group: Computerized Cognitive Training Group

Active Comparator group

Description:

The computerized cognitive training group will receive 16 sessions of training, 35 minutes each, conducted twice per week over a period of 8 weeks. Participants will be asked to complete a set of computerized tasks using Cogmed, a digital training programme which is proven to enhance working memory and attention level in children.

Treatment:

Behavioral: Computerized Cognitive Training

Waitlist Control Group

Other group

Description:

The waitlist control group will not receive any intervention until the intervention arms complete their training. Depending on the availability, either the fNIRS Neurofeedback-VR Training or the Computerized Cognitive Training will be offered to this group.

Treatment:

Behavioral: Computerized Cognitive Training

Behavioral: fNIRS Neurofeedback-VR Training