NCT01195961

Brief Summary

Background: \- Developmental dyscalculia is a learning disability in which individuals have difficulty learning or comprehending mathematics or other number concepts (such as keeping score during games, measuring time, or estimating distance). Developmental dyscalculia affects certain parts of the brain that are required for processing numbers. Research has shown that a form of brain stimulation called transcranial direct current stimulation (tDCS), applied when healthy individuals are being trained to carry out tasks with numbers, improved the ability to process numbers and solve math problems. More research is needed about whether tDCS can improve number processing in people with developmental dyscalculia. Objectives: \- To examine whether the effects of transcranial direct current stimulation can help individuals with developmental dyscalculia perform mathematical calculations. Eligibility: \- Individuals between 18 and 50 years of age who have been diagnosed with developmental dyscalculia, or are healthy volunteers without dyscalculia. Design:

  • Participants will have a screening visit and seven study visits. The screening visit and six of the study visits will take place consecutively over the course of 6 days, and the final visit will take place 3 months after the initial participation.
  • Participants will be screened with a medical history, physical and neurological examination, and a brief examination to test for dyscalculia and determine the participant's dominant hand.
  • Participants will be randomly assigned to one of two groups for the study. One group will receive tDCS during training to perform a task with numbers, and the other group will receive the same training with sham stimulation. Participants will not know which group they are in.
  • During the study visits, participants will be trained on number tasks on 6 consecutive days. Before the tDCS or sham stimulation is applied at the beginning of the experiment and at the end of each training day, participants will perform other tasks with numbers. Participants will be evaluated based on the accuracy and speed with which they respond to the questions.
  • At the followup visit, participants will perform the same number tasks they completed during the study visits. No tDCS will be performed at this visit.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 2, 2017

Status Verified

July 1, 2011

First QC Date

September 3, 2010

Last Update Submit

June 30, 2017

Conditions

Keywords

Direct Current StimulationLearningCognitive EnhancementCognitive TasksCognitive TrainingDevelopmental DyscalculiaLearning DisabilityCognition Disorder

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • We will include healthy volunteers and DD subjects who meet the following criteria:
  • Age 18 to 50 years
  • Able to provide informed consent
  • No history of math difficulties as determined by Dyscalculia Screener examination \> upper 50th percentile (healthy volunteers)
  • Diagnosed with DD and scored \< lower 25th percentile on Dyscalculia screening test (Developmental Dyscalculia subjects)
  • Edinburgh handedness inventory shows a laterality index (LI) \> 75 (dexterity) or LI of less than -75 (left-handedness)

You may not qualify if:

  • We will exclude healthy volunteers and DD subjects if one of the following conditions applies:
  • Unable to perform the tasks due to visual problems
  • History of seizures or brain tumor
  • History of alcohol or drug abuse (defined as the use of a drug for a nontherapeutic effect ) or psychiatric illness such as severe depression
  • History of brain surgery
  • Drug treatment acting primarily on the central nervous system, which lowers the seizure threshold such as antipsychotic drugs (chlorprozamine, clozapine).
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Rubinsten O, Henik A. Developmental dyscalculia: heterogeneity might not mean different mechanisms. Trends Cogn Sci. 2009 Feb;13(2):92-9. doi: 10.1016/j.tics.2008.11.002. Epub 2009 Jan 8.

    PMID: 19138550BACKGROUND
  • Cohen Kadosh R, Walsh V. Dyscalculia. Curr Biol. 2007 Nov 20;17(22):R946-7. doi: 10.1016/j.cub.2007.08.038. No abstract available.

    PMID: 18029243BACKGROUND
  • von Aster MG, Shalev RS. Number development and developmental dyscalculia. Dev Med Child Neurol. 2007 Nov;49(11):868-73. doi: 10.1111/j.1469-8749.2007.00868.x.

    PMID: 17979867BACKGROUND

MeSH Terms

Conditions

Cognition DisordersDyscalculiaLearning Disabilities

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersSpecific Learning DisorderCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental Disorders
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Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 6, 2010

Study Start

August 17, 2010

Study Completion

July 1, 2011

Last Updated

July 2, 2017

Record last verified: 2011-07-01

Locations