Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomised Controlled Trial of a Brain-Computer Interface Based Intervention for the Treatment of ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344044
• Other study ID #: DSRB Domain A/09/395
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 27, 2011
• Last updated: March 29, 2017
• Start date: January 2011
• Est. completion date: May 13, 2016

Study information

• Verified date: March 2017
• Source: National Healthcare Group, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to examine the efficacy of a brain-computer interface system for the treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesis is that children with ADHD receiving treatment with the BCI-based training will improve to a greater extent than the control group.

Additionally, the investigators are also conducting an fMRI study involving interested participants, to elucidate the neural mechanisms underlying any behavioural improvement. This is necessary to help the investigators gain a better picture of brain correlates related to ADHD and understand how the intervention can affect the brain.

Description:

This BCI study will involve 2 phases. The first phase is a preliminary study to test the safety and effectiveness of the novel BCI device which involves newly developed dry electrode sensors and intervention game. Twenty children, aged 6-12 and diagnosed with Inattentive or Combined subtype of ADHD will be recruited for the study. This open-label, experimental arm will go through 8 weeks of BCI intervention.

The second phase will be a randomized controlled trial involving 160 children. They will be randomized into the treatment or control arm. The treatment arm will receive 8 weeks of BCI intervention, similar to the experimental arm. The other group will serve as wait-list controls.

The fMRI trial aims to examine the underlying neural processes explaining any therapeutic effects that may be seen.

The study will enroll 70 children with ADHD, aged 6-12, who are participating in the main randomized controlled trial: 40 from the BrainpalTM intervention group and 30 from the control group; participants will undergo fMRI scan at Week 0 and 8 or Week 8 and 16. The study will recruit another 30 children aged 6-12 from the community as the healthy control group, who will undergo the same imaging procedure once. The scans will involve both functional and structural imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 13, 2016
• Est. primary completion date: May 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• DSM-IV-TR criteria for ADHD, either the combined or inattentive subtype, based on the Diagnostic Interview Schedule for Children (CDISC; Schaffer et al., 2000)

Exclusion Criteria:

• Present or history of medical treatment with stimulant medication and Atomoxetine

• Co-morbid severe psychiatric condition or known sensori-neural deficit e.g. complete blindness or deafness (such that they cannot play computer games)

• History of epileptic seizures

• Known Developmental Delay (i.e. IQ 70 and below)

• Predominantly Hyperactive/impulsive subtype of ADHD (i.e. no predominant inattentive symptoms)

• Present/history polyunsaturated fatty acids supplement intake (e.g. Omega-3 oil, flax seed oil, cod liver oil) in the past 3 months

• Present/history of traditional Chinese medicine (TCM) prescribed for treatment of attention problems in the past 1 month

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.

Locations

Country	Name	City	State
Singapore	Child Guidance Clinic, Institute of Mental Health	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National Healthcare Group, Singapore	Agency for Science, Technology and Research, Duke-NUS Graduate Medical School, Singapore Clinical Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition		Week 0, 8, 20, 24