Attention-Deficit/Hyperactivity Disorder (Combined-subtype)Phase 3NCT02151396
Effect of Working Memory Training on ADHD Brain Function
A Phase 3 study testing Working memory training and Functional magnetic resonance imaging (fMRI) in people with Attention-Deficit/Hyperactivity Disorder (Combined-subtype), run by Hartford Hospital at 1 site in United States.
Trial summary
There is evidence both that computer-administered cognitive training can improve ADHD working memory deficits and that this type of training in non-ADHD enhances normal working memory ability by altering brain activity in prefrontal cortex and the parietal lobe. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (Combined-subtype)
- What is being tested?
- Working memory training and Functional magnetic resonance imaging (fMRI)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2013
- Phase
- Phase 3
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants will be 13-17 years old and >6th grade English reading level to complete self-report evaluations (most are only available in English). ADHD-C participants must meet DSM-IV criteria (314.01).
Who cannot join
- Head injury sufficient to have caused >30 minutes lost consciousness; past or current CNS disease (e.g. stroke, MS, epilepsy or any repeated seizure history, tumor, etc) or brain lesion identified by MR (structural MR scans will be reviewed by a radiologist for the presence of clinical neuropathology that may affect cognitive task performance); Axis I DSM-IV lifetime history Bipolar disorder, psychotic disorder, OCD, PTSD, Tourette's disorder, Pervasive developmental disorder (e.g., Autistic disorder, PDD NOS, etc.); current DSM-IV substance dependence, Major Depressive Disorder or anxiety disorder; hypertension or juvenile-onset diabetes (current treatment with antihypertensives or insulin); current pregnancy (menstruating females will be tested); IQ estimate <80; left-handedness; psychotropic medication other than common psychostimulants that act primarily on dopamine neurotransmission systems. For instance, ADHD-C medications such as Wellbutrin (Buproprion), Strattera (Atomoxetine HCl), Cylert (Pemoline), or Provigil (Modafinil) will exclude participation; report of psychotic illness in first degree relative. Note, current DSM-IV disorders serve as exclusionary criteria to avoid the possibility of acute brain activity differences related more greatly to these disorders than ADHD. These stringent exclusion criteria are an advantage over many previous ADHD studies. However, given the frequent comorbidity and suspected biological liability among ADHD, substance, mood, and anxiety disorders, a lifetime history of mood or anxiety disorders will not exclude participation. Likewise, the frequent occurrence of CD/ODD and specific learning disabilities will not exclude participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Olin Neurospychiatry Research Center
Hartford, Connecticut, 06106
About this study
There is evidence both that computer-administered cognitive training can improve ADHD working memory deficits and that this type of training in non-ADHD enhances normal working memory ability by altering brain activity in prefrontal cortex and the parietal lobe. However, no study has characterized brain activity changes following working memory training in ADHD to understand what neural changes occur when cognitive deficits are remedied. This R21 exploratory study will examine the neural basis of cognitive training treatment gains in working memory, ADHD symptoms, and various other executive abilities. We will test the hypothesis that working memory training increases frontoparietal brain activation and examine other regions to see if there is any evidence for "neural compensation" (i.e., engagement of brain regions after training that are not normally recruited for task performance).
Read the detailed description
There is evidence both that computer-administered cognitive training can improve ADHD working memory deficits and that this type of training in non-ADHD enhances normal working memory ability by altering brain activity in prefrontal cortex and the parietal lobe. However, no study has characterized brain activity changes following working memory training in ADHD to understand what neural changes occur when cognitive deficits are remedied. This R21 exploratory study will examine the neural basis of cognitive training treatment gains in working memory, ADHD symptoms, and various other executive abilities. The study will compare n=21 ADHD adolescents with evidence for baseline deficits in working memory (i.e., <1.5 SD below normative ratings at baseline) before and after working memory training. Participants will undergo baseline neuropsychological and fMRI imaging with verbal and visuospatial Sternberg fMRI working memory tasks, 5 weeks of daily computerized working memory training, and then endpoint fMRI and cognitive evaluation of neural and behavioral changes. Training will utilize commercially-available Cogmed software (http://www.cogmed.com) as it has a well-developed set of computerized tools, with numerous practical advantages for this study. Our analyses will identify which brain regions in ADHD adolescents are affected by working memory treatment and characterize patterns of activation change between baseline and endpoint. We will examine post-treatment differences in the extent of activation and functional connectivity among activated brain regions to test hypotheses about possible neural mechanisms underlying treatment gains. Finally, we will conduct a series of analyses to determine what changes in brain function underlie a generalized effect of working memory training on ADHD symptoms and other 'executive' abilities. By identifying the neural correlates any such effect, this study could yield invaluable information about what the neural targets of any effective ADHD treatment must be. The key accomplishment of this exploratory study will be to characterize the neural basis of treatment gains in ADHD by testing theoretically-guided hypotheses about possible neuroplastic changes. The results will support larger, future studies aimed at better understanding the neural basis of this alternative treatment for ADHD, identifying biological or genetic factors that might denote the presence of a remediable working memory deficit, and ultimately achieving a better understanding of the etiology of ADHD working memory deficits.
- Being tested
- Working memory training, Functional magnetic resonance imaging (fMRI)
- Keywords
- ADHD, hyperactivity, inattention, working memory
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
Functional magnetic resonance imaging (fMRI)Device
| Study group | Role | What they receive |
|---|---|---|
| Cogmed Working Memory Training | Experimental | Cogmed (TM) working memory training following standard, recommended administration procedures Receives: Behavioral: Working memory training; Device: Functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI)
fMRI assessment of working memory-related brain function
Measured: 5 weeks
Secondary outcomes (2)
Working memory neuropsychological test performance
Several tests of working memory abillity
Measured: 5 weeks
ADHD clinical dysfunction
Parent- and self-reported ADHD symptom severity, ADHD-related problems, and role impairment at home
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJul 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (Combined-subtype)Studies 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 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Michael C. Stevens, Ph.D., Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151396
- Sponsor's protocol ID
- R21HD061915
- Status last verified
- May 2014
- First submitted
- 28 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Working Memory Training on ADHD Brain Function
- ClinicalTrials.gov ID
- NCT02151396
- Acronym / sponsor ID
- R21HD061915
- Keywords
- ADHD, hyperactivity, inattention, working memory
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 May 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.
There is evidence both that computer-administered cognitive training can improve ADHD working memory deficits and that this type of training in non-ADHD enhances normal working memory ability by altering brain activity in prefrontal cortex and the parietal lobe. However, no study has characterized brain activity changes following working memory training in ADHD to understand what neural changes occur when cognitive deficits are remedied. This R21 exploratory study will examine the neural basis of cognitive training treatment gains in working memory, ADHD symptoms, and various other executive abilities. We will test the hypothesis that working memory training increases frontoparietal brain activation and examine other regions to see if there is any evidence for "neural compensation" (i.e., engagement of brain regions after training that are not normally recruited for task performance).
Detailed description
There is evidence both that computer-administered cognitive training can improve ADHD working memory deficits and that this type of training in non-ADHD enhances normal working memory ability by altering brain activity in prefrontal cortex and the parietal lobe. However, no study has characterized brain activity changes following working memory training in ADHD to understand what neural changes occur when cognitive deficits are remedied. This R21 exploratory study will examine the neural basis of cognitive training treatment gains in working memory, ADHD symptoms, and various other executive abilities. The study will compare n=21 ADHD adolescents with evidence for baseline deficits in working memory (i.e., <1.5 SD below normative ratings at baseline) before and after working memory training. Participants will undergo baseline neuropsychological and fMRI imaging with verbal and visuospatial Sternberg fMRI working memory tasks, 5 weeks of daily computerized working memory training, and then endpoint fMRI and cognitive evaluation of neural and behavioral changes. Training will utilize commercially-available Cogmed software (http://www.cogmed.com) as it has a well-developed set of computerized tools, with numerous practical advantages for this study. Our analyses will identify which brain regions in ADHD adolescents are affected by working memory treatment and characterize patterns of activation change between baseline and endpoint. We will examine post-treatment differences in the extent of activation and functional connectivity among activated brain regions to test hypotheses about possible neural mechanisms underlying treatment gains. Finally, we will conduct a series of analyses to determine what changes in brain function underlie a generalized effect of working memory training on ADHD symptoms and other 'executive' abilities. By identifying the neural correlates any such effect, this study could yield invaluable information about what the neural targets of any effective ADHD treatment must be. The key accomplishment of this exploratory study will be to characterize the neural basis of treatment gains in ADHD by testing theoretically-guided hypotheses about possible neuroplastic changes. The results will support larger, future studies aimed at better understanding the neural basis of this alternative treatment for ADHD, identifying biological or genetic factors that might denote the presence of a remediable working memory deficit, and ultimately achieving a better understanding of the etiology of ADHD working memory deficits.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cogmed Working Memory Training | Experimental | Behavioral: Working memory training, Device: Functional magnetic resonance imaging (fMRI)Cogmed (TM) working memory training following standard, recommended administration procedures |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants will be 13-17 years old and >6th grade English reading level to complete self-report evaluations (most are only available in English). ADHD-C participants must meet DSM-IV criteria (314.01).
Key exclusion criteria (1 listed)
- Head injury sufficient to have caused >30 minutes lost consciousness; past or current CNS disease (e.g. stroke, MS, epilepsy or any repeated seizure history, tumor, etc) or brain lesion identified by MR (structural MR scans will be reviewed by a radiologist for the presence of clinical neuropathology that may affect cognitive task performance); Axis I DSM-IV lifetime history Bipolar disorder, psychotic disorder, OCD, PTSD, Tourette's disorder, Pervasive developmental disorder (e.g., Autistic disorder, PDD NOS, etc.); current DSM-IV substance dependence, Major Depressive Disorder or anxiety disorder; hypertension or juvenile-onset diabetes (current treatment with antihypertensives or insulin); current pregnancy (menstruating females will be tested); IQ estimate <80; left-handedness; psychotropic medication other than common psychostimulants that act primarily on dopamine neurotransmission systems. For instance, ADHD-C medications such as Wellbutrin (Buproprion), Strattera (Atomoxetine HCl), Cylert (Pemoline), or Provigil (Modafinil) will exclude participation; report of psychotic illness in first degree relative. Note, current DSM-IV disorders serve as exclusionary criteria to avoid the possibility of acute brain activity differences related more greatly to these disorders than ADHD. These stringent exclusion criteria are an advantage over many previous ADHD studies. However, given the frequent comorbidity and suspected biological liability among ADHD, substance, mood, and anxiety disorders, a lifetime history of mood or anxiety disorders will not exclude participation. Likewise, the frequent occurrence of CD/ODD and specific learning disabilities will not exclude participation.
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 |
|---|---|---|
| Working memory training | Behavioural | Cogmed Working Memory Training |
| Functional magnetic resonance imaging (fMRI) | Device | Cogmed Working Memory Training |
Primary outcome
Functional magnetic resonance imaging (fMRI)
Time frame: 5 weeks
fMRI assessment of working memory-related brain function
2 secondary outcomes
Working memory neuropsychological test performance
Time frame: 5 weeks
ADHD clinical dysfunction
Time frame: 5 weeks
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 30 May 2014.
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.
Michael C. Stevens, Ph.D. principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Working memory training and Functional magnetic resonance imaging (fMRI) in people with Attention-Deficit/Hyperactivity Disorder (Combined-subtype), run by Hartford Hospital at 1 site in United States.
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 1 inclusion and 1 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 30 May 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional magnetic resonance imaging (fMRI) (time frame: 5 weeks). 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 30 May 2014.