Single Ventricle Heart DiseaseNCT03687008
Cognitive Intervention to Improve Working Memory
A study testing Cognitive Computer Based Intervention in people with Single Ventricle Heart Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Single Ventricle Heart Disease
- What is being tested?
- Cognitive Computer Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 1 Jun 2022
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- be 14-18 years old
- have SVHD
- undergone Fontan completion
- understands English
- able to read computer screen
- have phone access
- MoCA score of 25 to 10
Who cannot join
- pregnancy
- claustrophobia
- presence of loose metal
- prior head injury or stroke
- clinical diagnosis of depression
- previous cardiac arrest and ECMO use
Show all 10Show fewer
- currently listed for heart transplant
- known genetic syndrome
- severe developmental delay
- born less than 35 weeks gestation
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA 300 Medical Plaza
Los Angeles, California, 90095
About this study
Official title: Cognitive Intervention to Improve Working Memory in Adolescents With Single Ventricle Heart Disease
Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Primary objective is to evaluate the impact of the Cogmed intervention on working memory scores and the secondary objective to assess brain tissue changes with magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI) techniques, measures of mean diffusivity pre- and post-intervention.
Read the detailed description
Adolescents with single ventricle heart disease (SVHD) show brain injuries in sites (hippocampus, mammillary bodies, thalamus, and frontal cortices) that are associated with cognitive deficits, in particular working memory. A key component of cognition, and thus, an important influence on academic performance, self-care ability, quality of life, and morbidity and mortality, is working memory. However, it is unclear whether cognition, as well as brain tissue integrity can be improved with cognition intervention. Among available interventions, a possible intervention to improve working memory and brain status in SVHD is Cogmed®, which is an interactive, computer-based intervention, specifically designed for children and young adults, to improve attention and working memory with significant effectiveness in other pediatric conditions associated with brain injury. A unique feature of the Cogmed ® program is the in-home support of trained coaches for the duration of the intervention (5 days/week for 5 weeks), which optimizes adherence and confirms completion of the tasks. The investigators will use a one group pre- post-intervention design, 20 subjects (10 males and 10 females), with inclusion criteria: 14-18 years of age, have undergone surgical palliation, and score 25-10 (mild to moderate cognitive impairment) on the Montreal Cognitive Assessment (MoCA) screener. Using non-invasive brain magnetic resonance imaging (MRI) procedures, diffusion tensor imaging (DTI) based mean diffusivity (MD), an MRI measure of tissue integrity, can identify changes in the hippocampus, mammillary bodies, thalamus, and frontal cortices pre- and post- cognitive intervention. Therefore, the specific aims of this proposal are to: 1) examine the impact of Cogmed® intervention on working memory (working memory index [WMI] score from the WRAML2) in adolescents with SVHD (pre- and post-intervention); 2) assess the effect of Cogmed® on brain structural integrity (DTI-based MD procedures) in sites that control memory (hippocampus, mammillary bodies, thalamus, and frontal cortices) in adolescents with SVHD (pre- and post-intervention); and 3) examine if there is an impact of the Cogmed® intervention on cognition and brain tissue integrity based on sex in SVHD.
In summary, SVHD adolescents have significant cognitive deficits that are linked to brain injury in regions, which control such functions. Intervention to improve cognition and brain injury in SVHD is unclear, but a potential innovative treatment for such symptoms and brain injury is Cogmed®. The information from this pilot study has the potential to revolutionize the clinical treatment specific to cognitive deficits in SVHD and other types of congenital heart defects. In addition, the clinical implications are considerable as improved working memory skill has the potential to increase academic achievement, improve self-care, reduce mortality and morbidity, and increase quality of life in this high risk, growing population.
- Conditions
- Single Ventricle Heart Disease
- Being tested
- Cognitive Computer Based Intervention
- Keywords
- Cognition, Working Memory, Magnetic Resonance Imaging, Cogmed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Computer Based InterventionBehavioural
Also called Cogmed Version 4.0
25 sessions [each 30-45 minutes, 5 days a week / for 5 weeks], supervised by trained coaches
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with SVHD | Experimental | All adolescents will receive the intervention Cogmed. This is an in home, computer based, cognitive intervention to improve working memory, supervised by trained coaches, [25 sessions, each 30-45 minutes, 5 days a week / 5 week duration]. Receives: Behavioral: Cognitive Computer Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Working Memory Index [WMI] Scores
To be measured by the Wide Range Assessment of Memory and Learning, version 2 [WRAML 2], working memory index [mean 100, SD 15] subscale. This is an administered test by trained personnel which measures all aspects of memory [visual, verbal, working memory, attention / concentration]. Lower scores indicate worse working memory deficits [1 SD below normal is < 85].
Measured: Baseline, 6 weeks
Secondary outcomes (1)
Changes in Mean Diffusivity [MD] Values [brain tissue changes]
To be measured non-invasively via brain MRI using diffusion tensor imaging (DTI) techniques, which measure mean diffusivity (MD) values (increased values indicate worse tissue injury).
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start10 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Ventricle Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- one group, pre- post-intervention design
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Nancy Pike, PhD, RN, University of California, Los Angeles
- Investigators
- Nancy Pike, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687008
- Sponsor's protocol ID
- 92418
- Status last verified
- Sep 2022
- First submitted
- 25 Sep 2018
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Intervention to Improve Working Memory in Adolescents With Single Ventricle Heart Disease
- ClinicalTrials.gov ID
- NCT03687008
- Acronym / sponsor ID
- 92418
- Conditions
- Single Ventricle Heart Disease
- Keywords
- Cognition, Working Memory, Magnetic Resonance Imaging, Cogmed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 27 Sep 2018 (actual)
- 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.
Adolescents with single ventricle heart disease (SVHD) (10 males and 10 females) with mild to moderate cognitive impairment will participate in a total of 25 computer-based working memory training sessions, each 30-40 minutes (5 days a week for 5 weeks) supervised by a trained coach. Primary objective is to evaluate the impact of the Cogmed intervention on working memory scores and the secondary objective to assess brain tissue changes with magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI) techniques, measures of mean diffusivity pre- and post-intervention.
Detailed description
Adolescents with single ventricle heart disease (SVHD) show brain injuries in sites (hippocampus, mammillary bodies, thalamus, and frontal cortices) that are associated with cognitive deficits, in particular working memory. A key component of cognition, and thus, an important influence on academic performance, self-care ability, quality of life, and morbidity and mortality, is working memory. However, it is unclear whether cognition, as well as brain tissue integrity can be improved with cognition intervention. Among available interventions, a possible intervention to improve working memory and brain status in SVHD is Cogmed®, which is an interactive, computer-based intervention, specifically designed for children and young adults, to improve attention and working memory with significant effectiveness in other pediatric conditions associated with brain injury. A unique feature of the Cogmed ® program is the in-home support of trained coaches for the duration of the intervention (5 days/week for 5 weeks), which optimizes adherence and confirms completion of the tasks. The investigators will use a one group pre- post-intervention design, 20 subjects (10 males and 10 females), with inclusion criteria: 14-18 years of age, have undergone surgical palliation, and score 25-10 (mild to moderate cognitive impairment) on the Montreal Cognitive Assessment (MoCA) screener. Using non-invasive brain magnetic resonance imaging (MRI) procedures, diffusion tensor imaging (DTI) based mean diffusivity (MD), an MRI measure of tissue integrity, can identify changes in the hippocampus, mammillary bodies, thalamus, and frontal cortices pre- and post- cognitive intervention. Therefore, the specific aims of this proposal are to: 1) examine the impact of Cogmed® intervention on working memory (working memory index [WMI] score from the WRAML2) in adolescents with SVHD (pre- and post-intervention); 2) assess the effect of Cogmed® on brain structural integrity (DTI-based MD procedures) in sites that control memory (hippocampus, mammillary bodies, thalamus, and frontal cortices) in adolescents with SVHD (pre- and post-intervention); and 3) examine if there is an impact of the Cogmed® intervention on cognition and brain tissue integrity based on sex in SVHD.
In summary, SVHD adolescents have significant cognitive deficits that are linked to brain injury in regions, which control such functions. Intervention to improve cognition and brain injury in SVHD is unclear, but a potential innovative treatment for such symptoms and brain injury is Cogmed®. The information from this pilot study has the potential to revolutionize the clinical treatment specific to cognitive deficits in SVHD and other types of congenital heart defects. In addition, the clinical implications are considerable as improved working memory skill has the potential to increase academic achievement, improve self-care, reduce mortality and morbidity, and increase quality of life in this high risk, growing population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one group, pre- post-intervention design
| Arm | Type | Receives |
|---|---|---|
| Adolescents with SVHD | Experimental | Behavioral: Cognitive Computer Based InterventionAll adolescents will receive the intervention Cogmed. This is an in home, computer based, cognitive intervention to improve working memory, supervised by trained coaches, [25 sessions, each 30-45 minutes, 5 days a week / 5 week duration]. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- be 14-18 years old
- have SVHD
- undergone Fontan completion
- understands English
- able to read computer screen
Key exclusion criteria (10 listed)
- pregnancy
- claustrophobia
- presence of loose metal
- prior head injury or stroke
- clinical diagnosis of depression
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 |
|---|---|---|
| Cognitive Computer Based InterventionAlso: Cogmed Version 4.025 sessions [each 30-45 minutes, 5 days a week / for 5 weeks], supervised by trained coaches | Behavioural | Adolescents with SVHD |
Primary outcome
Changes in Working Memory Index [WMI] Scores
Time frame: Baseline, 6 weeks
To be measured by the Wide Range Assessment of Memory and Learning, version 2 [WRAML 2], working memory index [mean 100, SD 15] subscale. This is an administered test by trained personnel which measures all aspects of memory [visual, verbal, working memory, attention / concentration]. Lower scores indicate worse working memory deficits [1 SD below normal is < 85].
1 secondary outcome
Changes in Mean Diffusivity [MD] Values [brain tissue changes]
Time frame: Baseline, 6 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 21 Sep 2022.
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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.
Nancy Pike, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Computer Based Intervention in people with Single Ventricle Heart Disease, run by University of California, Los Angeles 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 7 inclusion and 10 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 21 Sep 2022. 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?
Changes in Working Memory Index [WMI] Scores (time frame: Baseline, 6 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 21 Sep 2022.