Clinical trial NCT06743763: fNIRS-Based Neurofeedback Training in Children With ADHD: The Effects of VR
Official title: Comparative Effectiveness of fNIRS-Based Neurofeedback Training in Children With ADHD: The Impact of Virtual Reality Integration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity (ADHD)
Keywords: neurofeedback
fNIRS
ADHD
children
virtual reality
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 138
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training (coupled with virtual reality), twice per week, each lasting 1 hour.

Comparative group 1: receives 8-week functional near-infrared spectroscopy (fNIRS) neurofeedback training without virtual reality(VR) technology, twice per week, each lasting 1 hour.

Comparative group 2: receives 8-week training using VR technology (without neurofeedback) twice per week, each lasting 1 hour.
Primary purpose: TREATMENT

Brief summary: The study aims to explore whether the treatment using fNIRS-based neurofeedback training for children with attention-deficit/hyperactivity disorder (ADHD) is useful. Furthermore, the study hopes to evaluate whether the use of virtual reality (VR) technology will have an impact on the treatment's effectiveness.

The program includes the following components:

Participants will be randomly assigned to one of three intervention groups: the neurofeedback with virtual reality (VR) group, the 2D neurofeedback group (with no VR technology applied), and the VR without neurofeedback group. All participants will complete academic-related tasks in simulated lessons. Participants in the VR neurofeedback group will wear VR goggles and a neurofeedback device that measures blood oxy-hemoglobin levels in brain cortical tissue and provides feedback via visual images or auditory sounds to the participants. Those in the 2D neurofeedback group will use a computer to complete the tasks, with all other settings (e.g., neurofeedback settings) remaining the same. The VR without neurofeedback group will wear VR goggles to complete tasks, but without the neurofeedback component.

All participants will complete a total of 16 training sessions over 8 weeks (twice a week), with each session lasting approximately 35 to 60 minutes.

To investigate the intervention's effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory before 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 will be conducted at the laboratory at the University of Hong Kong. Additionally, parents and teachers will be asked to complete a questionnaire assessing children's behavior at home and at school at three time points.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to answer the first five questions in 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

Primary outcomes:
measure: Children's ADHD symptoms
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Children's ADHD symptoms
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Children's ADHD symptoms
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Secondary outcomes:
measure: Conners Continuous Performance Test 3rd Edition (CPT 3)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Conners Continuous Performance Test 3rd Edition (CPT 3)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Conners Continuous Performance Test 3rd Edition (CPT 3)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Functional NIRS
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Functional NIRS
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Functional NIRS
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Number subtest of Children's Memory Scale (CMS)
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Number subtest of Children's Memory Scale (CMS)
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Number subtest of Children's Memory Scale (CMS)
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Behavioural ratings on children's executive functions
timeFrame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
Other outcomes:
measure: Children's enjoyment of the training
timeFrame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
measure: Feasibility of conducting VR training within children
timeFrame: Up to 8 to 10 weeks (within the intervention period)
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Kar-man Kathy Shum, PhD
role: PRINCIPAL_INVESTIGATOR
References: