Attention Deficit Hyperactivity Disorder (ADHD)NCT02917109
LearningRx Cognitive Training for ADHD
A study testing LearningRx cognitive training in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Gibson Institute of Cognitive Research at 1 site in United States.
Trial summary
The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD. Read more about this study
- Who is it for?
- Ages 15 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- LearningRx cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Dec 2017
- 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 15 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 15-22 previously diagnosed with ADHD
- High school students or college students with a prior diagnosis of ADHD living in the greater Colorado Springs area
Who cannot join
- No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Gibson Institute of Cognitive Research
Colorado Springs, Colorado, 80919
About this study
Official title: LearningRx Cognitive Training for ADHD: A Multiple Baseline Study Across Cases
The purpose of this investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD.
Read the detailed description
Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for ADHD.
- Being tested
- LearningRx cognitive training
- 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.
LearningRx cognitive trainingBehavioural
A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.
| Study group | Role | What they receive |
|---|---|---|
| LearningRx cognitive training | Experimental | The intervention is a 60-hour, clinician-delivered cognitive training program. Receives: Behavioral: LearningRx cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of overall cognitive function improvement
Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities
Measured: within 14 days after completing the intervention
Secondary outcomes (4)
Evidence of change in brain activity
As confirmed by pretest to post-test changes in electrical activity measured by qEEG
Measured: within 30 days after completing the intervention
Evidence of reduction in ADHD symptoms
As confirmed by pretest to post-test changes on the ADHD Rating Scale
Measured: within 14 days after completing the intervention
Evidence of change in brain structure
Confirmed by change in pretest to post-test neuroimaging using MRI
Measured: within 30 days after completing the intervention
Evidence of improvement in visual or auditory attention
Confirmed by change in pretest to post-test scores on the Conners Continous Performance Test (CPT-3) and Auditory Attention Test (CATA)
Measured: with 14 days after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionDec 2017
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 (ADHD)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gibson Institute of Cognitive Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Ledbetter, PhD, Principal investigator, Gibson Institute of Cognitive ResearchAmy L Moore, PhD, Study director, Gibson Institute of Cognitive Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917109
- Sponsor's protocol ID
- GICR-0916-A
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will add to Harvard Dataverse
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LearningRx Cognitive Training for ADHD: A Multiple Baseline Study Across Cases
- ClinicalTrials.gov ID
- NCT02917109
- Acronym / sponsor ID
- GICR-0916-A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Gibson Institute of Cognitive ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Sep 2016 (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 investigation is to conduct a series of case studies on the impact of LearningRx cognitive training on cognitive skills, brain structure, and daily functioning for participants with ADHD.
Detailed description
Using a multiple baseline design across cases with start point randomization, the proposed study will examine the outcomes from LearningRx one-on-one cognitive training across domains on standardized measures used to monitor treatment effectiveness for ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LearningRx cognitive training | Experimental | Behavioral: LearningRx cognitive trainingThe intervention is a 60-hour, clinician-delivered cognitive training program. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 15-22 previously diagnosed with ADHD
- High school students or college students with a prior diagnosis of ADHD living in the greater Colorado Springs area
Key exclusion criteria (1 listed)
- No braces, metal implants, or claustrophobia that would contraindicate magnetic resonance imaging
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 |
|---|---|---|
| LearningRx cognitive trainingA clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks. | Behavioural | LearningRx cognitive training |
Primary outcome
Evidence of overall cognitive function improvement
Time frame: within 14 days after completing the intervention
Confirmed by change in pretest to post-test scores on the Woodcock Johnson IV - Tests of Cognitive Abilities
4 secondary outcomes
Evidence of change in brain activity
Time frame: within 30 days after completing the intervention
Evidence of reduction in ADHD symptoms
Time frame: within 14 days after completing the intervention
Evidence of change in brain structure
Time frame: within 30 days after completing the intervention
Evidence of improvement in visual or auditory attention
Time frame: with 14 days after completing the intervention
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 15 Feb 2018.
- Individual participant dataSharing planned: Yes. Will add to Harvard Dataverse
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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.
Christina Ledbetter, PhD principal investigator
Gibson Institute of Cognitive Research
Amy L Moore, PhD study director
Gibson Institute of Cognitive Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LearningRx cognitive training in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Gibson Institute of Cognitive Research 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 2 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 15 Feb 2018. 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.
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?
Evidence of overall cognitive function improvement (time frame: within 14 days after completing the intervention). 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 15 Feb 2018.