Sickle Cell DiseaseNCT01793740
Cognitive Rehabilitation in Sickle Cell Disease
A study testing Cogmed in people with Sickle Cell Disease and Cognitive Impairment, run by Duke University at 1 site in United States.
Trial summary
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Sickle Cell Disease, Cognitive Impairment
- What is being tested?
- Cogmed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2014
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1) Children with a diagnosis of SCD (all genotypes)
- 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
- 3) a standard score ≥1 standard deviation below the mean (<90) on the tasks of executive function or WM from the Cogstate (mean=100; SD=10)
Who cannot join
- 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
- 2) a diagnosis of depression or a pervasive developmental disorder (by history);
- 3) clinical stroke (via record medical history); or
- 4) non-English fluency.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
Official title: Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed. Pilot data will also be collected to establish preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life. Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12). Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week). Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit. After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit. Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention. If interested, they will follow the same intervention protocol described above. These children will return to clinic for a third visit following completion of the intervention. Compliance rate and its confidence interval will be calculated for the overall study population. A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target. Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).
- Conditions
- Sickle Cell Disease, Cognitive Impairment
- Being tested
- Cogmed
- Keywords
- sickle cell disease, pediatric, learning disability, cognitive impairment, memory, attention, Children with sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell, Cognitive Dysfunction, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogmedBehavioural
Also called Cogmed computerized cognitive training
Computer based program that aims to improve children's memory, attention, and processing speed.
| Study group | Role | What they receive |
|---|---|---|
| Cogmed | Experimental | These children are enrolled in the Cogmed intervention. Receives: Behavioral: Cogmed |
| Waitlist | No intervention | These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility is defined as 75% of subjects completing 80% of the training program.
Measured: Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
Secondary outcomes (1)
Efficacy
Efficacy will be defined by participant performance on cognitive outcome measures including executive functioning outcomes from the Cogstate.
Measured: Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie J Bonner, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793740
- Sponsor's protocol ID
- Pro00035303
- Status last verified
- Aug 2014
- First submitted
- 14 Feb 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT01793740
- Acronym / sponsor ID
- Pro00035303
- Conditions
- Sickle Cell Disease, Cognitive Impairment
- Keywords
- sickle cell disease, pediatric, learning disability, cognitive impairment, memory, attention, Children with sickle cell disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Feb 2013 (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 majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed. Pilot data will also be collected to establish preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life. Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12). Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week). Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit. After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit. Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention. If interested, they will follow the same intervention protocol described above. These children will return to clinic for a third visit following completion of the intervention. Compliance rate and its confidence interval will be calculated for the overall study population. A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target. Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cogmed | Experimental | Behavioral: CogmedThese children are enrolled in the Cogmed intervention. |
| Waitlist | No intervention | –These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1) Children with a diagnosis of SCD (all genotypes)
- 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
- 3) a standard score ≥1 standard deviation below the mean (<90) on the tasks of executive function or WM from the Cogstate (mean=100; SD=10)
Key exclusion criteria (4 listed)
- 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
- 2) a diagnosis of depression or a pervasive developmental disorder (by history);
- 3) clinical stroke (via record medical history); or
- 4) non-English fluency.
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 |
|---|---|---|
| CogmedAlso: Cogmed computerized cognitive trainingComputer based program that aims to improve children's memory, attention, and processing speed. | Behavioural | Cogmed |
Primary outcome
Feasibility
Time frame: Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
Feasibility is defined as 75% of subjects completing 80% of the training program.
1 secondary outcome
Efficacy
Time frame: Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
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 20 Aug 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.
Melanie J Bonner, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed in people with Sickle Cell Disease and Cognitive Impairment, run by Duke University 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 3 inclusion and 4 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 20 Aug 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.
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?
Feasibility (time frame: Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment). 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 20 Aug 2014.