Attention Deficit Hyperactivity DisorderNCT02071186
The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With ADHD
A study testing Virtual Reality training and Computerized Cognitive Remediation in people with Attention Deficit Hyperactivity Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to test the hypothesis that cognitive remediation and virtual reality treatment approaches can enhance cognitive and motor function in children with ADHD. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Virtual Reality training and Computerized Cognitive Remediation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Mar 2015
- 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
- Children diagnosed with ADHD by a pediatrician, child neurologist or child psychiatrist, according to the ADHD criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition.
- Attending regular education frameworks
- Have access to a personal computer at home
Who cannot join
- Children on active medication for ADHD during the study period
- Are taking any other medication that could affect attention, balance or motor function
- Have a serious medical condition that could affect attention, gait or balance
- Have any known genetic syndromes, autism, neurological conditions or psychiatric disorders or any medical illness requiring immediate treatment
- Are participating in a competing exercise program designed to improve gait or balance
Trial locations and contacts
1 site in 1 country.
Yael Leitner, MD contact
Anat Mirelman, PhD contact
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Anat Mirelman, PhD, anatmi@tlvmc.gov.il
Yael Leitner, MD
About this study
Official title: The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With Attention Deficit Hyperactivity Disorder
The purpose of this study is to test the hypothesis that cognitive remediation and virtual reality treatment approaches can enhance cognitive and motor function in children with ADHD.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurobehavioral disorder affecting children. ADHD is currently treated with a combination of medication and behavioral therapy aimed at reducing the negative symptoms. Pharmacologic treatment methods, such as the use of Methylphenidate (MPH) have many drawbacks including high cost and side effects.
Non-pharmacological treatment approaches teach strategies aimed at improving behavior and environmental management. Evidence on efficacy of these treatments is lacking and the literature only supports the 'parental education' approach.
Motor aspects of the disorder tend to be undertreated. Studies have shown that persistent use of MPH has a positive effect on motor output timing and coordination in children with ADHD. Thus non-pharmacological interventions aimed at improving attention are likely to also improve other aspects of the disorder such as motor problems and thus should be further explored.
Various computerized remediation programs have been developed as a non-pharmacological alternative for children with ADHD. The programs present exercises that require sustained attention and a response to set rules and are often graded in task complexity according to the user's abilities.
Virtual Reality (VR) is a simulation of the real world using computer graphics that requires interaction, immersion and active participation by the user. VR applications have shown to be effective in improving attention in children and adolescents with behavioral problems, teaching them to focus on some tasks more than existing cognitive training programs. VR while walking has demonstrated improvements in both motor and cognitive function in older adults and patients with neurodegenerative diseases suggesting a beneficial effect on motor and cognitive function. However this treatment has not been tested yet in ADHD.
The study will investigate the following aims:
- To compare the effect of computerized cognitive remediation and VR on attention and gait in children with ADHD.
- To examine the long term effects of computerized cognitive remediation and VR on attention and gait in children with ADHD.
- To compare, in an exploratory analysis, the effects of the non-pharmacological training paradigms to standard of care treatment on attention and gait in children with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Virtual Reality training, Computerized Cognitive Remediation, Standard of care
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality trainingDevice
Subjects will train with the VR system at the Tel Aviv Sourasky Medical Center 3 times per week for 6 weeks with each session lasting approximately 30 minutes.
To assure participants' safety and maintaining progress, training with the VR will be individual and provided by qualified physiotherapists, who use the system on a daily basis.
Computerized Cognitive RemediationOther
Subjects in this study will train with the AttenGo program at home 3-5 times per week for 6 weeks with each session lasting approximately 30 minutes.
Standard of careOther
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality training | Experimental | Subjects will be asked to walk on a treadmill while negotiating virtual obstacles. The VR system includes a camera based motion capture and a computer generated simulation. The camera is used to capture the movement of the participant's feet. These images are then transferred to the computer simulation and projected to the patient on a screen. The speed, orientation, size, frequency of appearance and shape of the targets are manipulated to increase task difficulty. The Virtual environment imposes a cognitive load requiring attention and response selection as well as processing of rich visual stimuli involving several perceptual processes. The system provides visual and auditory feedback of task performance to enhance motor learning. Receives: Device: Virtual Reality training |
| Computerized Cognitive Remediation | Experimental | The "AttenGo" program will be used for neuro-cognitive remediation aimed at enhancing attention, concentration, working memory, and executive function. The program has shown to be effective in improving attention and executive function in children with ADHD. The training is composed of cognitive exercises that challenge subjects with problem solving, information processing, response inhibition and dividing attention. The users receive immediate feedback from the system when losing focus. The program is adaptive and progresses according to the subjects abilities. Receives: Other: Computerized Cognitive Remediation |
| Control group | Active comparator | Subjects in this group will be assessed based on the study protocol but will receive no treatment other than their standard of care which could include pharmacological or/ and non-pharmacological treatment. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in gait function
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Measured: One week post intervention
Immediate change in cognitive function
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared to baseline performance.
Measured: One week post intervention
Secondary outcomes (2)
Retention of change in gait function
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared performance at baseline and at one week post intervention.
Measured: One month post intervention
Retention of change in cognitive function
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared performance at baseline and at one week post intervention.
Measured: One month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yael Leitner, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071186
- Sponsor's protocol ID
- TASMC-13-YL-0544-CTIL
- Status last verified
- Feb 2014
- First submitted
- 15 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-pharmacological Novel Cognitive Interventions on Motor-Cognitive Function in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02071186
- Acronym / sponsor ID
- TASMC-13-YL-0544-CTIL
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 25 Feb 2014 (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.
The purpose of this study is to test the hypothesis that cognitive remediation and virtual reality treatment approaches can enhance cognitive and motor function in children with ADHD.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurobehavioral disorder affecting children. ADHD is currently treated with a combination of medication and behavioral therapy aimed at reducing the negative symptoms. Pharmacologic treatment methods, such as the use of Methylphenidate (MPH) have many drawbacks including high cost and side effects.
Non-pharmacological treatment approaches teach strategies aimed at improving behavior and environmental management. Evidence on efficacy of these treatments is lacking and the literature only supports the 'parental education' approach.
Motor aspects of the disorder tend to be undertreated. Studies have shown that persistent use of MPH has a positive effect on motor output timing and coordination in children with ADHD. Thus non-pharmacological interventions aimed at improving attention are likely to also improve other aspects of the disorder such as motor problems and thus should be further explored.
Various computerized remediation programs have been developed as a non-pharmacological alternative for children with ADHD. The programs present exercises that require sustained attention and a response to set rules and are often graded in task complexity according to the user's abilities.
Virtual Reality (VR) is a simulation of the real world using computer graphics that requires interaction, immersion and active participation by the user. VR applications have shown to be effective in improving attention in children and adolescents with behavioral problems, teaching them to focus on some tasks more than existing cognitive training programs. VR while walking has demonstrated improvements in both motor and cognitive function in older adults and patients with neurodegenerative diseases suggesting a beneficial effect on motor and cognitive function. However this treatment has not been tested yet in ADHD.
The study will investigate the following aims:
- To compare the effect of computerized cognitive remediation and VR on attention and gait in children with ADHD.
- To examine the long term effects of computerized cognitive remediation and VR on attention and gait in children with ADHD.
- To compare, in an exploratory analysis, the effects of the non-pharmacological training paradigms to standard of care treatment on attention and gait in children with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality training | Experimental | Device: Virtual Reality trainingSubjects will be asked to walk on a treadmill while negotiating virtual obstacles. The VR system includes a camera based motion capture and a computer generated simulation. The camera is used to capture the movement of the participant's feet. These images are then transferred to the computer simulation and projected to the patient on a screen. The speed, orientation, size, frequency of appearance and shape of the targets are manipulated to increase task difficulty. The Virtual environment imposes a cognitive load requiring attention and response selection as well as processing of rich visual stimuli involving several perceptual processes. The system provides visual and auditory feedback of task performance to enhance motor learning. |
| Computerized Cognitive Remediation | Experimental | Other: Computerized Cognitive RemediationThe "AttenGo" program will be used for neuro-cognitive remediation aimed at enhancing attention, concentration, working memory, and executive function. The program has shown to be effective in improving attention and executive function in children with ADHD. The training is composed of cognitive exercises that challenge subjects with problem solving, information processing, response inhibition and dividing attention. The users receive immediate feedback from the system when losing focus. The program is adaptive and progresses according to the subjects abilities. |
| Control group | Active comparator | Other: Standard of careSubjects in this group will be assessed based on the study protocol but will receive no treatment other than their standard of care which could include pharmacological or/ and non-pharmacological treatment. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with ADHD by a pediatrician, child neurologist or child psychiatrist, according to the ADHD criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition.
- Attending regular education frameworks
- Have access to a personal computer at home
Key exclusion criteria (5 listed)
- Children on active medication for ADHD during the study period
- Are taking any other medication that could affect attention, balance or motor function
- Have a serious medical condition that could affect attention, gait or balance
- Have any known genetic syndromes, autism, neurological conditions or psychiatric disorders or any medical illness requiring immediate treatment
- Are participating in a competing exercise program designed to improve gait or balance
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 |
|---|---|---|
| Virtual Reality trainingSubjects will train with the VR system at the Tel Aviv Sourasky Medical Center 3 times per week for 6 weeks with each session lasting approximately 30 minutes. To assure participants' safety and maintaining progress, training with the VR will be individual and provided by qualified physiotherapists, who use the system on a daily basis. | Device | Virtual Reality training |
| Computerized Cognitive RemediationSubjects in this study will train with the AttenGo program at home 3-5 times per week for 6 weeks with each session lasting approximately 30 minutes. | Other | Computerized Cognitive Remediation |
| Standard of care | Other | Control group |
Primary outcome
Immediate change in gait function
Time frame: One week post intervention
Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.
Immediate change in cognitive function
Time frame: One week post intervention
A computerized neuropsychological test battery will be used to assess different cognitive domains including memory, attention, executive function, visual spatial processing and a global cognitive composite score. These measures will be compared to baseline performance.
2 secondary outcomes
Retention of change in gait function
Time frame: One month post intervention
Retention of change in cognitive function
Time frame: One month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
Yael Leitner, MD contact
Anat Mirelman, PhD contact
Yael Leitner, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality training and Computerized Cognitive Remediation in people with Attention Deficit Hyperactivity Disorder, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Feb 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Leitner, MD (leitnery@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate change in gait function (time frame: One week post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2014.