Turner SyndromeNCT03459651
Effect of Turner Syndrome on Number Sense
A study testing ANS training in people with Turner Syndrome, run by Stanford University at 1 site in United States.
Trial summary
This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Read more about this study
- Who is it for?
- Ages 6 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome
- What is being tested?
- ANS training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 2 Apr 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 6 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children, adolescents, and adult women with Turner syndrome.
- Healthy controls.
- Normal or corrected to normal vision.
Who cannot join
- Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder).
- Chemical dependency
- Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Brain Sciences Research
Stanford, California, 94305
About this study
Official title: Investigation of the Role of Turner Syndrome on Approximate Number Sense
This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Participants will undergo weekly training sessions in their own home. Half of the participants will complete 2 training sessions a week for 8 weeks, and the second half will complete 1 training session for 8 weeks.
- Conditions
- Turner Syndrome
- Being tested
- ANS training
- Keywords
- numeracy, number sense
- Medical subject headings
- Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS trainingBehavioural
In-home computer-based ANS training
| Study group | Role | What they receive |
|---|---|---|
| ANS training | Experimental | Not described Receives: Behavioral: ANS training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single and multiple-operand addition and subtraction accuracy
Task accuracy calculated as the percentage of trials answered correctly.
Measured: 8 weeks
Single and multiple-operand addition and subtraction response time
Average amount of time, in seconds, required to answer each question on the task.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Apr 2022
- Primary completion2 Apr 2022
- Study completion2 Apr 2022
Why it stopped: Principal Investigator elected to end the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Michael Baker, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459651
- Sponsor's protocol ID
- 092883
- Status last verified
- May 2022
- First submitted
- 27 Feb 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data for the primary outcome measures may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role of Turner Syndrome on Approximate Number Sense
- ClinicalTrials.gov ID
- NCT03459651
- Acronym / sponsor ID
- 092883
- Conditions
- Turner Syndrome
- Keywords
- numeracy, number sense
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator elected to end the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 2 Apr 2022 (actual)
- First posted
- 9 Mar 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.
This study evaluates approximate number sense (ANS) in children, adolescents, and adult women with Turner syndrome compared to age-matched healthy peers. One primary aim of this project is to assess the effectiveness of an online ANS training tool in enhancing complex mathematics ability. Participants will undergo weekly training sessions in their own home. Half of the participants will complete 2 training sessions a week for 8 weeks, and the second half will complete 1 training session for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANS training | Experimental | Behavioral: ANS training |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children, adolescents, and adult women with Turner syndrome.
- Healthy controls.
- Normal or corrected to normal vision.
Key exclusion criteria (3 listed)
- Major psychiatric or developmental disorder (e.g., bipolar disorder, major depression, psychotic disorders, intellectual disability, autism spectrum disorder).
- Chemical dependency
- Currently taking the following medications: antidepressant, antipsychotic, and anti-seizures drugs.
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 |
|---|---|---|
| ANS trainingIn-home computer-based ANS training | Behavioural | ANS training |
Primary outcome
Single and multiple-operand addition and subtraction accuracy
Time frame: 8 weeks
Task accuracy calculated as the percentage of trials answered correctly.
Single and multiple-operand addition and subtraction response time
Time frame: 8 weeks
Average amount of time, in seconds, required to answer each question on the task.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data for the primary outcome measures may be made available upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANS training in people with Turner Syndrome, run by Stanford 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 3 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: withdrawn, as of the sponsor's last update on 9 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Single and multiple-operand addition and subtraction accuracy (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 9 May 2022.