Attention Deficit Hyperactivity DisorderASDBCINCT02618135
Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD
A study testing Intervention Group in people with Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorders, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
This project involves creating a novel and personalised BCI training system that targets social and communication difficulties, and inattentive symptoms problems often found in ASD/ADHD children. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorders
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- May 2016to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meets diagnostic criteria for ASD, based on Autism Diagnostic Observation Scale (ADOS) and/or Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV-TR) / 5th edition (DSM 5);
- Meets diagnostic criteria for ADHD inattentive or combined subtype, based on the Computerised Diagnostic Interview for Children (C-DISC);
- Score 12 and above on the ADHD Rating Scale (ADHD-RS);
- IQ above 70;
- If on medication, dose has been stable or unchanged for at least preceding 3 months
- Parents and teachers are English-speaking
Who cannot join
- Co-morbid severe psychiatric condition or known sensory-neural deficit e.g. complete blindness or deafness.
- Color blindness
- History of epileptic seizures.
- Known to have developmental delay (i.e. IQ 70 and below).
- Predominantly hyperactive/impulsive subtype of ADHD.
- Change in dosage of medication (if on medication)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Brain-Computer Interface-based Programme for the Treatment of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder in Children: A Pilot Study
This project involves creating a novel and personalised BCI training system that targets social and communication difficulties, and inattentive symptoms problems often found in ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they will undergo 24 training sessions over an 8-week period. During these sessions, the children will play a computer game interface specifically designed to train attention and facial and emotional recognition, while using our BCI device. To further reinforce the treatment, the training system has been enhanced with the inclusion of an eye-tracker to target the lack of preferential eye contact that children with ASD exhibit. The investigators hypothesize that participants will show improvements in social skills and attention post treatment.
Read the detailed description
This pilot trial aims to improve attention levels in children with comorbid ASD/ADHD. Twenty participants aged 8 to 12 years with comorbid ASD/ADHD will be recruited. Most therapy involves at least a total of 20 sessions (4); as such, the intervention protocol includes 24 sessions followed by a follow up one month after completion. The participants will attend 24 brain training sessions over an 8-week period, playing computer games designed for improving attention, facial recognition, and emotion recognition.
Participants will be randomized to either the Intervention or Waitlist-Control study arm group, where the latter proceeds with training only after a wait-time of 8 weeks. The investigators hypothesize that participants in the Intervention group will show improved symptoms compared to the Waitlist-Control group at week 8. This pilot study will provide preliminary data to support the efficacy of the investigators new BCI-based training programme and potentially pave the way for a larger randomized controlled trial.
Children with comorbid ASD/ADHD have greater impairments in attention, social skills and eye gaze. The investigators believe that focusing on these symptoms might lead to potentially better treatment outcomes. Also, current treatments for ASD/ADHD are limited in that they are taxing, time-consuming, and incur side effects. If the BCI-based training programme has a positive impact on children diagnosed with ASD and ADHD, it can potentially be an alternative long-term treatment. Unlike medications and behavioural interventions, neurofeedback therapy has no side effects and may be more engaging for children. It has the potential to be made available eventually for use at the patient's own home and can therefore be administered at one's own time and convenience.
In 2010, the PI and his team conducted a pilot study to investigate a novel intervention for treatment of ADHD. The study involved subjects 7 to 12 years of age diagnosed with either combined or inattentive ADHD subtypes. The subjects received 20 sessions of BCI training over a 10-week period. The BCI training is an innovative design integrating neurofeedback system using an algorithm to analyze EEG brain waves, using it to drive a computer interface by sustaining a certain threshold of attention. Teachers of children in the intervention group reported larger improvements in the ADHD inattentive score although this was not statistically significant. Parents also fed back that the intervention was relatively safe to use and free of adverse effects.
In 2012, the team completed another study that improved upon the technology and investigated the feasibility of the new training programme (with a simpler headset using two dry lead sensors instead of an EEG cap) on 20 unmedicated ADHD children participants. The treatment intervention was intensified to 24 sessions over 8 weeks followed by 3 monthly booster training sessions. An additional component was added to the training module where participants were required to complete a stroop task calibration process before the training. This is to personalise the intervention and improve accuracy of the EEG parameters. In this open-label trial, parents reported statistically significant improvements in both inattentive and hyperactive-impulsive symptoms on the ADHD Rating Scale at 8 weeks, which further suggests the potential efficaciousness of the novel BCI-based training programme as a potentially efficacious treatment for ADHD.
In 2013, a larger-scale randomised controlled trial began to further investigate the efficacy of the BCI training on treating inattentive symptoms of ADHD. The randomized study aims to enroll 160 children between the age of 6 to 12 who will undergo 24 sessions of BCI training sessions over 8 weeks followed by 3 booster sessions. ADHD symptoms will be assessed primarily by blinded clinicians and parents as well as based on feedback obtained from respective school teachers. The study is currently ongoing and is estimated to complete by July 2016. Therapy using non-invasive BCI system-based games may represent an alternative treatment for children with ADHD and ASD. If demonstrated to be efficacious, parents are likely to prefer this as compared to current treatment modalities of medications (with potentially serious side effects) and behavior management (parents generally find this difficult and challenging). Children themselves are also more likely to enjoy the treatment and hence, comply better.
In the longer term, this approach and system may have potential for attention and cognitive enhancement for patients with cognitive impairment or early dementia.
- Being tested
- Intervention Group, Control Group
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Also called BCI Training
Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.
Control GroupOther
Also called Waitlist BCI Training
Participants will wait for 8 weeks before training intervention begins.
Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 10 child participants in the intervention group will take part in a total of 24 sessions spread over an 8-week period, and a final follow-up review 1 month after the completion of the training session. If sessions are missed during the 8-weeks period due to unforeseen circumstances (e.g. sickness, travel plans), arrangements will be made for participants to attend up to 5 BCI-based therapy sessions per week. All participants will have to complete a minimum of 20 sessions within the 8-weeks period for treatment efficacy. Receives: Other: Intervention Group |
| Control Group | Other | 10 child participants in the control group will not receive BCI training during the first 8 weeks of their study participation; they will act as controls. At week 9, subjects in this group will go through the BCI training similar to the intervention group. If sessions are missed during the 8-weeks period due to unforeseen circumstances (e.g. sickness, travel plans), arrangements will be made for participants to attend up to 5 BCI-based therapy sessions per week. All participants will have to complete a minimum of 20 sessions within the 8-weeks period for treatment efficacy. They will take part in a total of 24 sessions spread over an 8-week period, followed by a final follow-up review 1 month after the completion of the training sessions. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale (clinicians)
The primary outcome of this study will be the change in the inattentive score on the ADHD Rating Scale as rated by the clinicians from week 1 to week 8.
Measured: Week 1 to Week 8
Secondary outcomes (8)
ADHD Rating Scale (parent)
The change in the inattentive score of the ADHD RS rated by parent from week 1 to week 8.
Measured: Week 1 to Week 8
ADHD Rating Scale (clinician and parent)
The change in the inattentive score of the ADHD RS rated by clinician and parent from week 1 to week 8.
Measured: Week 1 to Week 8
ADHD Rating Scale
The change in parent rated ADHD-RS from week 1 to week 8.
Measured: Week 1 to Week 8
Social Responsiveness Scale
The change in parent rated SRS from week 1 to week 8.
Measured: Week 1 to Week 8
Clinical Global Assessment Scale (C-GAS)
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Measured: Week 1 to Week 8
Clinical Global Impression Severity Scale (CGI-S)
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Measured: Week 1 to Week 8
Clinical Global Impression Improvement Scale (CGI-I)
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Measured: Week 1 to Week 8
Conners' Continuous Performance Test (CPT-II)
Measured: Week 1 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionMar 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Mental Health, Singapore, Agency for Science, Technology and Research
- Responsible party
- Principal investigator, Lee Tih Shih, Duke-NUS Graduate Medical School
- Investigators
- Choon Guan Lim, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618135
- Sponsor's protocol ID
- 2015/00841
- Other IDs
- 2015
- Acronym
- ASDBCI
- Status last verified
- Jul 2020
- First submitted
- 23 Nov 2015
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Jang J, Matson JL, Williams LW, Tureck K, Goldin RL, Cervantes PE. RETRACTED: Rates of comorbid symptoms in children with ASD, ADHD, and comorbid ASD and ADHD. Res Dev Disabil. 2013 Aug;34(8):2369-78. doi: 10.1016/j.ridd.2013.04.021. Epub 2013 May 22.
PubMed 23708709Rommelse NN, Franke B, Geurts HM, Hartman CA, Buitelaar JK. Shared heritability of attention-deficit/hyperactivity disorder and autism spectrum disorder. Eur Child Adolesc Psychiatry. 2010 Mar;19(3):281-95. doi: 10.1007/s00787-010-0092-x. Epub 2010 Feb 11.
PubMed 20148275Coben R, Linden M, Myers TE. Neurofeedback for autistic spectrum disorder: a review of the literature. Appl Psychophysiol Biofeedback. 2010 Mar;35(1):83-105. doi: 10.1007/s10484-009-9117-y.
PubMed 19856096Linden M, Habib T, Radojevic V. A controlled study of the effects of EEG biofeedback on cognition and behavior of children with attention deficit disorder and learning disabilities. Biofeedback Self Regul. 1996 Mar;21(1):35-49. doi: 10.1007/BF02214148.
PubMed 8833315Gevensleben H, Holl B, Albrecht B, Vogel C, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry. 2009 Jul;50(7):780-9. doi: 10.1111/j.1469-7610.2008.02033.x. Epub 2009 Jan 12.
PubMed 19207632Lim CG, Lee TS, Guan C, Sheng Fung DS, Cheung YB, Teng SS, Zhang H, Krishnan KR. Effectiveness of a brain-computer interface based programme for the treatment of ADHD: a pilot study. Psychopharmacol Bull. 2010;43(1):73-82.
PubMed 20581801Lee TS, Goh SJ, Quek SY, Phillips R, Guan C, Cheung YB, Feng L, Teng SS, Wang CC, Chin ZY, Zhang H, Ng TP, Lee J, Keefe R, Krishnan KR. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy. PLoS One. 2013 Nov 18;8(11):e79419. doi: 10.1371/journal.pone.0079419. eCollection 2013.
PubMed 24260218Jones W, Carr K, Klin A. Absence of preferential looking to the eyes of approaching adults predicts level of social disability in 2-year-old toddlers with autism spectrum disorder. Arch Gen Psychiatry. 2008 Aug;65(8):946-54. doi: 10.1001/archpsyc.65.8.946.
PubMed 18678799
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brain-Computer Interface-based Programme for the Treatment of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder in Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT02618135
- Acronym / sponsor ID
- ASDBCI / 2015/00841
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Institute of Mental Health, Singapore, Agency for Science, Technology and Research
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project involves creating a novel and personalised BCI training system that targets social and communication difficulties, and inattentive symptoms problems often found in ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they will undergo 24 training sessions over an 8-week period. During these sessions, the children will play a computer game interface specifically designed to train attention and facial and emotional recognition, while using our BCI device. To further reinforce the treatment, the training system has been enhanced with the inclusion of an eye-tracker to target the lack of preferential eye contact that children with ASD exhibit. The investigators hypothesize that participants will show improvements in social skills and attention post treatment.
Detailed description
This pilot trial aims to improve attention levels in children with comorbid ASD/ADHD. Twenty participants aged 8 to 12 years with comorbid ASD/ADHD will be recruited. Most therapy involves at least a total of 20 sessions (4); as such, the intervention protocol includes 24 sessions followed by a follow up one month after completion. The participants will attend 24 brain training sessions over an 8-week period, playing computer games designed for improving attention, facial recognition, and emotion recognition.
Participants will be randomized to either the Intervention or Waitlist-Control study arm group, where the latter proceeds with training only after a wait-time of 8 weeks. The investigators hypothesize that participants in the Intervention group will show improved symptoms compared to the Waitlist-Control group at week 8. This pilot study will provide preliminary data to support the efficacy of the investigators new BCI-based training programme and potentially pave the way for a larger randomized controlled trial.
Children with comorbid ASD/ADHD have greater impairments in attention, social skills and eye gaze. The investigators believe that focusing on these symptoms might lead to potentially better treatment outcomes. Also, current treatments for ASD/ADHD are limited in that they are taxing, time-consuming, and incur side effects. If the BCI-based training programme has a positive impact on children diagnosed with ASD and ADHD, it can potentially be an alternative long-term treatment. Unlike medications and behavioural interventions, neurofeedback therapy has no side effects and may be more engaging for children. It has the potential to be made available eventually for use at the patient's own home and can therefore be administered at one's own time and convenience.
In 2010, the PI and his team conducted a pilot study to investigate a novel intervention for treatment of ADHD. The study involved subjects 7 to 12 years of age diagnosed with either combined or inattentive ADHD subtypes. The subjects received 20 sessions of BCI training over a 10-week period. The BCI training is an innovative design integrating neurofeedback system using an algorithm to analyze EEG brain waves, using it to drive a computer interface by sustaining a certain threshold of attention. Teachers of children in the intervention group reported larger improvements in the ADHD inattentive score although this was not statistically significant. Parents also fed back that the intervention was relatively safe to use and free of adverse effects.
In 2012, the team completed another study that improved upon the technology and investigated the feasibility of the new training programme (with a simpler headset using two dry lead sensors instead of an EEG cap) on 20 unmedicated ADHD children participants. The treatment intervention was intensified to 24 sessions over 8 weeks followed by 3 monthly booster training sessions. An additional component was added to the training module where participants were required to complete a stroop task calibration process before the training. This is to personalise the intervention and improve accuracy of the EEG parameters. In this open-label trial, parents reported statistically significant improvements in both inattentive and hyperactive-impulsive symptoms on the ADHD Rating Scale at 8 weeks, which further suggests the potential efficaciousness of the novel BCI-based training programme as a potentially efficacious treatment for ADHD.
In 2013, a larger-scale randomised controlled trial began to further investigate the efficacy of the BCI training on treating inattentive symptoms of ADHD. The randomized study aims to enroll 160 children between the age of 6 to 12 who will undergo 24 sessions of BCI training sessions over 8 weeks followed by 3 booster sessions. ADHD symptoms will be assessed primarily by blinded clinicians and parents as well as based on feedback obtained from respective school teachers. The study is currently ongoing and is estimated to complete by July 2016. Therapy using non-invasive BCI system-based games may represent an alternative treatment for children with ADHD and ASD. If demonstrated to be efficacious, parents are likely to prefer this as compared to current treatment modalities of medications (with potentially serious side effects) and behavior management (parents generally find this difficult and challenging). Children themselves are also more likely to enjoy the treatment and hence, comply better.
In the longer term, this approach and system may have potential for attention and cognitive enhancement for patients with cognitive impairment or early dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention Group10 child participants in the intervention group will take part in a total of 24 sessions spread over an 8-week period, and a final follow-up review 1 month after the completion of the training session. If sessions are missed during the 8-weeks period due to unforeseen circumstances (e.g. sickness, travel plans), arrangements will be made for participants to attend up to 5 BCI-based therapy sessions per week. All participants will have to complete a minimum of 20 sessions within the 8-weeks period for treatment efficacy. |
| Control Group | Other | Other: Control Group10 child participants in the control group will not receive BCI training during the first 8 weeks of their study participation; they will act as controls. At week 9, subjects in this group will go through the BCI training similar to the intervention group. If sessions are missed during the 8-weeks period due to unforeseen circumstances (e.g. sickness, travel plans), arrangements will be made for participants to attend up to 5 BCI-based therapy sessions per week. All participants will have to complete a minimum of 20 sessions within the 8-weeks period for treatment efficacy. They will take part in a total of 24 sessions spread over an 8-week period, followed by a final follow-up review 1 month after the completion of the training sessions. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Meets diagnostic criteria for ASD, based on Autism Diagnostic Observation Scale (ADOS) and/or Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV-TR) / 5th edition (DSM 5);
- Meets diagnostic criteria for ADHD inattentive or combined subtype, based on the Computerised Diagnostic Interview for Children (C-DISC);
- Score 12 and above on the ADHD Rating Scale (ADHD-RS);
- IQ above 70;
- If on medication, dose has been stable or unchanged for at least preceding 3 months
Key exclusion criteria (6 listed)
- Co-morbid severe psychiatric condition or known sensory-neural deficit e.g. complete blindness or deafness.
- Color blindness
- History of epileptic seizures.
- Known to have developmental delay (i.e. IQ 70 and below).
- Predominantly hyperactive/impulsive subtype of ADHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: BCI TrainingEach participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology. | Other | Intervention Group |
| Control GroupAlso: Waitlist BCI TrainingParticipants will wait for 8 weeks before training intervention begins. Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology. | Other | Control Group |
Primary outcome
ADHD Rating Scale (clinicians)
Time frame: Week 1 to Week 8
The primary outcome of this study will be the change in the inattentive score on the ADHD Rating Scale as rated by the clinicians from week 1 to week 8.
8 secondary outcomes
ADHD Rating Scale (parent)
Time frame: Week 1 to Week 8
ADHD Rating Scale (clinician and parent)
Time frame: Week 1 to Week 8
ADHD Rating Scale
Time frame: Week 1 to Week 8
Social Responsiveness Scale
Time frame: Week 1 to Week 8
Clinical Global Assessment Scale (C-GAS)
Time frame: Week 1 to Week 8
Clinical Global Impression Severity Scale (CGI-S)
Time frame: Week 1 to Week 8
Clinical Global Impression Improvement Scale (CGI-I)
Time frame: Week 1 to Week 8
Conners' Continuous Performance Test (CPT-II)
Time frame: Week 1 to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 23708709Jang J, Matson JL, Williams LW, Tureck K, Goldin RL, Cervantes PE. RETRACTED: Rates of comorbid symptoms in children with ASD, ADHD, and comorbid ASD and ADHD. Res Dev Disabil. 2013 Aug;34(8):2369-78. doi: 10.1016/j.ridd.2013.04.021. Epub 2013 May 22.
- Background: PubMed 20148275Rommelse NN, Franke B, Geurts HM, Hartman CA, Buitelaar JK. Shared heritability of attention-deficit/hyperactivity disorder and autism spectrum disorder. Eur Child Adolesc Psychiatry. 2010 Mar;19(3):281-95. doi: 10.1007/s00787-010-0092-x. Epub 2010 Feb 11.
- Background: PubMed 19856096Coben R, Linden M, Myers TE. Neurofeedback for autistic spectrum disorder: a review of the literature. Appl Psychophysiol Biofeedback. 2010 Mar;35(1):83-105. doi: 10.1007/s10484-009-9117-y.
- Background: PubMed 8833315Linden M, Habib T, Radojevic V. A controlled study of the effects of EEG biofeedback on cognition and behavior of children with attention deficit disorder and learning disabilities. Biofeedback Self Regul. 1996 Mar;21(1):35-49. doi: 10.1007/BF02214148.
- Background: PubMed 19207632Gevensleben H, Holl B, Albrecht B, Vogel C, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry. 2009 Jul;50(7):780-9. doi: 10.1111/j.1469-7610.2008.02033.x. Epub 2009 Jan 12.
- Background: PubMed 20581801Lim CG, Lee TS, Guan C, Sheng Fung DS, Cheung YB, Teng SS, Zhang H, Krishnan KR. Effectiveness of a brain-computer interface based programme for the treatment of ADHD: a pilot study. Psychopharmacol Bull. 2010;43(1):73-82.
- Background: PubMed 24260218Lee TS, Goh SJ, Quek SY, Phillips R, Guan C, Cheung YB, Feng L, Teng SS, Wang CC, Chin ZY, Zhang H, Ng TP, Lee J, Keefe R, Krishnan KR. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy. PLoS One. 2013 Nov 18;8(11):e79419. doi: 10.1371/journal.pone.0079419. eCollection 2013.
- Background: PubMed 18678799Jones W, Carr K, Klin A. Absence of preferential looking to the eyes of approaching adults predicts level of social disability in 2-year-old toddlers with autism spectrum disorder. Arch Gen Psychiatry. 2008 Aug;65(8):946-54. doi: 10.1001/archpsyc.65.8.946.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choon Guan Lim principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorders, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Rating Scale (clinicians) (time frame: Week 1 to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618135, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.