Fragile X SyndromeNCT02747394
Cognitive Training for Fragile X Syndrome
A study testing Working Memory Training in people with Fragile X Syndrome, run by University of California, Davis at 1 site in United States.
Trial summary
Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Fragile X Syndrome
- What is being tested?
- Working Memory Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 18 Oct 2018
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- fragile X full mutation
- normal or corrected vision
- English or Spanish speaking
- ability to pass three-span items following completion of a Cogmed training session at baseline
- parental agreement to maintain adherence to the training schedule and to not alter other treatments during the study unless medically necessary
Who cannot join
- previous Cogmed training
- significant medical problems that would interfere with the study or significant brain trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
M.I.N.D. Institute, U.C. Davis
Sacramento, California, 95817
About this study
Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and behavioral deficits. This translational work has led to multiple national and international controlled trials in humans with FXS now underway. However, in contrast to the heavy focus on medication treatments, there have been no controlled trials to empirically-validate cognitive or behavioral interventions for FXS. The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the efficacy of Cogmed, a cognitive training program proven to enhance working memory and executive/frontal function in a variety of clinical populations. Demonstration of effective Cogmed training for FXS would represent a major advance in the field, one that may also generalize to other forms of intellectual disability. Furthermore, it is critical to determine whether the targeted pharmacological treatments can accelerate learning and cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for testing hypotheses focused on combined efficacy of medication and cognitive training.
- Conditions
- Fragile X Syndrome
- Being tested
- Working Memory Training
- Medical subject headings
- Fragile X Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working Memory TrainingOther
Also called Cogmed
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Cogmed | Experimental | 5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed Receives: Other: Working Memory Training |
| Non-Adaptive Cogmed | Other | 5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed Receives: Other: Working Memory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory
Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory
Measured: 5-6 weeks
Secondary outcomes (8)
Wechsler Intelligence Scale for Children-IV Digit Span
Measured: 5-6 weeks
Wechsler Intelligence Scale for Children-IV Digit Span
Measured: 3 month followup
Kiddie Test of Attentional Performance (KiTAP)
Measured: 5-6 weeks
Kiddie Test of Attentional Performance (KiTAP)
Measured: 3 month followup
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Measured: 5-6 weeks
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Measured: 3 month followup
Swanson, Nolan and Pelham (SNAP-IV)
Measured: 5-6 weeks
Swanson, Nolan and Pelham (SNAP-IV)
Measured: 3 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJan 2013
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fragile X SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hessl, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747394
- Sponsor's protocol ID
- 428005
- Status last verified
- May 2019
- First submitted
- 5 Apr 2016
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hessl D, Schweitzer JB, Nguyen DV, McLennan YA, Johnston C, Shickman R, Chen Y. Cognitive training for children and adolescents with fragile X syndrome: a randomized controlled trial of Cogmed. J Neurodev Disord. 2019 Apr 15;11(1):4. doi: 10.1186/s11689-019-9264-2.
PubMed 30982467
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training for Fragile X Syndrome
- ClinicalTrials.gov ID
- NCT02747394
- Acronym / sponsor ID
- 428005
- Conditions
- Fragile X Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 21 Apr 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.
Individuals with fragile X syndrome (FXS) demonstrate profound executive function deficits that interfere with learning, socialization and emotion regulation. Extensive research focused on the animal models of FXS show that targeted pharmacological agents can normalize synaptic connectivity and reverse cognitive and behavioral deficits. This translational work has led to multiple national and international controlled trials in humans with FXS now underway. However, in contrast to the heavy focus on medication treatments, there have been no controlled trials to empirically-validate cognitive or behavioral interventions for FXS. The proposed study, the first non-pharmacological controlled trial for FXS, will evaluate the efficacy of Cogmed, a cognitive training program proven to enhance working memory and executive/frontal function in a variety of clinical populations. Demonstration of effective Cogmed training for FXS would represent a major advance in the field, one that may also generalize to other forms of intellectual disability. Furthermore, it is critical to determine whether the targeted pharmacological treatments can accelerate learning and cognitive development. Thus, the validation of Cogmed for FXS will provide a paradigm for testing hypotheses focused on combined efficacy of medication and cognitive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Cogmed | Experimental | Other: Working Memory Training5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of adaptive Cogmed |
| Non-Adaptive Cogmed | Other | Other: Working Memory Training5 days per week for 5-6 weeks of parent aided visual working memory training, consisting of non-adaptive Cogmed |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- fragile X full mutation
- normal or corrected vision
- English or Spanish speaking
- ability to pass three-span items following completion of a Cogmed training session at baseline
- parental agreement to maintain adherence to the training schedule and to not alter other treatments during the study unless medically necessary
Key exclusion criteria (2 listed)
- previous Cogmed training
- significant medical problems that would interfere with the study or significant brain trauma
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 TrainingAlso: Cogmed | Other | Adaptive Cogmed, Non-Adaptive Cogmed |
Primary outcome
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory
Time frame: 5-6 weeks
Average of z scores obtained from Block Span and Leiter-R Spatial Working Memory
8 secondary outcomes
Wechsler Intelligence Scale for Children-IV Digit Span
Time frame: 5-6 weeks
Wechsler Intelligence Scale for Children-IV Digit Span
Time frame: 3 month followup
Kiddie Test of Attentional Performance (KiTAP)
Time frame: 5-6 weeks
Kiddie Test of Attentional Performance (KiTAP)
Time frame: 3 month followup
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Time frame: 5-6 weeks
Behavior Rating Inventory Rating of Executive Function (BRIEF; Teacher and Caregiver Reports)
Time frame: 3 month followup
Swanson, Nolan and Pelham (SNAP-IV)
Time frame: 5-6 weeks
Swanson, Nolan and Pelham (SNAP-IV)
Time frame: 3 month followup
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 3 May 2019.
- Derived from this study: PubMed 30982467Hessl D, Schweitzer JB, Nguyen DV, McLennan YA, Johnston C, Shickman R, Chen Y. Cognitive training for children and adolescents with fragile X syndrome: a randomized controlled trial of Cogmed. J Neurodev Disord. 2019 Apr 15;11(1):4. doi: 10.1186/s11689-019-9264-2.
- Individual participant dataSharing planned: Undecided
Related trials for Fragile X Syndrome
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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.
David Hessl principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working Memory Training in people with Fragile X Syndrome, run by University of California, Davis 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 5 inclusion and 2 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 3 May 2019. 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?
Composite of Stanford Binet, Fifth Edition Block Span and Leiter-R Spatial Working Memory (time frame: 5-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747394, which also lists 1 linked publication.
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 3 May 2019.