Effect of Turner Syndrome on Number Sense | NCT03459651

Studies
Effect of Turner Syndrome on Number Sense

NCT03459651

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

May 9, 2022Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Turner Syndrome

Interventions

ANS training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator elected to end the study.

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Apr 2, 2022Actual

Completion Date

Apr 2, 2022Actual

First Submitted Date

Feb 27, 2018

First Submission Date that Met QC Criteria

Mar 2, 2018

First Posted Date

Mar 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2022

Last Update Posted Date

May 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ANS training	Experimental		Behavioral: ANS training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANS training	Behavioral	In-home computer-based ANS training	ANS training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Single and multiple-operand addition and subtraction accuracy	Task accuracy calculated as the percentage of trials answered correctly.	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.	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children, adolescents, and adult women with Turner syndrome.
Healthy controls.
Normal or corrected to normal vision.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Interdisciplinary Brain Sciences Research		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

De-identified individual participant data for the primary outcome measures may be made available upon reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014424	Turner Syndrome

Ancestor Terms

ID	Term
D006059	Gonadal Dysgenesis
D012734	Disorders of Sex Development
D014564	Urogenital Abnormalities
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided