Randomized Controlled Trials of the Effects of Near-infrared Spectroscopy (fNIRS) Neurofeedback Training Coupled With Virtual Reality Technology in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• Children aged 7- 12

• Clinical diagnosis of ADHD

• Significant teacher- or parent-reported attention problems during screening

Locations
Other Locations
Hong Kong Special Administrative Region
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Kathy Tsam Ling KEI
hkuadhdvr@outlook.com
+852 6939 4425
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2026-01-11
Participants
Target number of participants: 138
Treatments
Experimental: Experimental Group: fNIRS Neurofeedback-VR Training Group
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.
Active_comparator: Active Control Group: Computerized Cognitive Training Group
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.
Other: Waitlist Control Group
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.
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov