Cognition DisorderNCT01195961
Facilitating Numerical Processing With Transcranial Stimulation in Developmental Dyscalculia
An observational study of Cognition Disorder and Brain Mapping, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorder, Brain Mapping
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2010to 1 Jul 2011
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Facilitating Numerical Processing With Transcranial DC Stimulation in Developmental Dyscalculia
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.
Read more
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.
Read the detailed description
Objectives
Developmental dyscalculia (DD) is a condition in which subjects cannot process adequately numerical concepts. Performance of arithmetical calculations is associated with fMRI activity in an extended brain network that includes parietal and prefrontal cortices. Areas within the parietal lobe, required for numerical processing in healthy subjects, are abnormal in subjects with DD. The purpose of this single-blinded study is to determine if facilitatory transcranial direct current stimulation (tDCS) of these parietal areas in association with numerical training will improve processing of numerical information relative to sham in subjects with DD and in healthy volunteers.
Study population
30 healthy volunteers and 30 subjects with developmental dyscalculia (DD).
Design
Healthy volunteers and subjects with DD will be randomly assigned to one of two groups. Each group will receive anodal tDCS or sham with numerical training. All subjects will participate in 7 sessions. First, they will be trained on an ordinal numerical task (numerical training task) in which they will learn the magnitude relations between two numbers on 6 consecutive days while receiving sham stimulation or tDCS during the training. Subjects will see two numbers on the screen, one viewed on the left side of the screen and the other on the right side of the screen (example, 2, 4), and they have to decide which one is larger. Performance will be evaluated by fitting a power-law function. Before the beginning of the experiment and after each training day subjects will perform a numerical Stroop task that assesses the automaticity of numerical processing, and a number-space task that will provide information on the subject's accuracy of mapping numbers into space. At the end of each of the 6 training days (immediately post training) and 3 months (seventh session) later (retention measure) subjects will be tested on a dyscalculia test (The Dyscalculia Screener),the numerical Stroop task, and the number-space task
Outcome Measures
The primary outcome measure will be the improvement in automatic numerical processing (numerical Stroop task) as reflected by reaction times. Secondary outcomes are accuracy when mapping numbers into space (number-space task) and improvement in the dyscalculia score (Dyscalculia Screener).
- Conditions
- Cognition Disorder, Brain Mapping
- Keywords
- Direct Current Stimulation, Learning, Cognitive Enhancement, Cognitive Tasks, Cognitive Training, Developmental Dyscalculia, Learning Disability, Cognition Disorder
- Medical subject headings
- Cognition Disorders, Dyscalculia, Learning Disabilities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study start17 Aug 2010
- Study completion1 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognition DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195961
- Sponsor's protocol ID
- 100194
- Other IDs
- 10-N-0194
- Status last verified
- 1 Jul 2011
- First submitted
- 3 Sep 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 19138550Cohen 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.
PubMed 18029243von 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.
PubMed 17979867
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Numerical Processing With Transcranial DC Stimulation in Developmental Dyscalculia
- ClinicalTrials.gov ID
- NCT01195961
- Acronym / sponsor ID
- 100194
- Conditions
- Cognition Disorder, Brain Mapping
- Keywords
- Direct Current Stimulation, Learning, Cognitive Enhancement, Cognitive Tasks, Cognitive Training, Developmental Dyscalculia, Learning Disability, Cognition Disorder
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 17 Aug 2010
- Study completion
- 1 Jul 2011
- First posted
- 6 Sep 2010 (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.
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.
Detailed description
Objectives
Developmental dyscalculia (DD) is a condition in which subjects cannot process adequately numerical concepts. Performance of arithmetical calculations is associated with fMRI activity in an extended brain network that includes parietal and prefrontal cortices. Areas within the parietal lobe, required for numerical processing in healthy subjects, are abnormal in subjects with DD. The purpose of this single-blinded study is to determine if facilitatory transcranial direct current stimulation (tDCS) of these parietal areas in association with numerical training will improve processing of numerical information relative to sham in subjects with DD and in healthy volunteers.
Study population
30 healthy volunteers and 30 subjects with developmental dyscalculia (DD).
Design
Healthy volunteers and subjects with DD will be randomly assigned to one of two groups. Each group will receive anodal tDCS or sham with numerical training. All subjects will participate in 7 sessions. First, they will be trained on an ordinal numerical task (numerical training task) in which they will learn the magnitude relations between two numbers on 6 consecutive days while receiving sham stimulation or tDCS during the training. Subjects will see two numbers on the screen, one viewed on the left side of the screen and the other on the right side of the screen (example, 2, 4), and they have to decide which one is larger. Performance will be evaluated by fitting a power-law function. Before the beginning of the experiment and after each training day subjects will perform a numerical Stroop task that assesses the automaticity of numerical processing, and a number-space task that will provide information on the subject's accuracy of mapping numbers into space. At the end of each of the 6 training days (immediately post training) and 3 months (seventh session) later (retention measure) subjects will be tested on a dyscalculia test (The Dyscalculia Screener),the numerical Stroop task, and the number-space task
Outcome Measures
The primary outcome measure will be the improvement in automatic numerical processing (numerical Stroop task) as reflected by reaction times. Secondary outcomes are accuracy when mapping numbers into space (number-space task) and improvement in the dyscalculia score (Dyscalculia Screener).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 19138550Rubinsten 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.
- Background: PubMed 18029243Cohen 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.
- Background: PubMed 17979867von 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.
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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?
An observational study of Cognition Disorder and Brain Mapping, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 6 inclusion and 7 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195961, which also lists 3 linked publications.
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 2 Jul 2017.