Clinical trial NCT04242680: tRNS Combined to Cognitive Training in Children With Dyscalculia
Official title: Improving Math Deficits in Children With Dyscalculia by tRNS: a Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Dyscalculia
Keywords: Children
Adolescents
tRNS
transcranial random noise stimulation
EEG
numerical abilities
neurodevelopmental disorders
non-invasive brain stimulation
transcranial electrical stimulation
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 102
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study grounds on the absence of evidence-based treatment in individuals with developmental dyscalculia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) over dorsolateral prefrontal cortex (DLPFC) or posterior parietal cortex (PPC), cerebral areas usually disrupted in individuals with DD, in addition to a usual treatment such as cognitive training.

Therefore, the investigators hypothesized that active tRNS over DLPFC or PPC combined to cognitive training will boost math and math-related skills in children and adolescents with DD, modulating theta/beta ratio around stimulated cerebral network. On the contrary, sham tRNS (placebo) over DLPFC or PPC combined to cognitive training will not have significant effect in improving math skills. Further, both active and sham tRNS combined to cognitive training will be safe and well tolerated.

Detailed description: The study design is randomized stratified, double blind, placebo-controlled.

A group of children and adolescents with DD will be selected and randomly assigned to three different conditions: 1. tRNS over bilateral DLPFC + cognitive training (Brainstim DLPFC); 2. tRNS over bilateral PPC (Brainstim PPC) + cognitive training; 3. sham tRNS (bilateral DLPFC/bilateral PPC; Brainstim Sham) + cognitive training.

In this project, the investigators will work to understand whether a brain-based intervention, with the use of tRNS, combined to a usual treatment can improve the outcome of individual with DD.

The protocol will allow the investigators to:

1. testing the critical role of two brain regions (DLPFC or PPC) usually involved in numerical abilities and disrupted in individuals with DD;
2. examining the neural changes (using EEG recordings) due to cognitive training without tRNS (Brainstim Sham) and with tRNS (Brainstim DLPFC; Brainstim PPC);
3. predicting training outcomes based on math-related skills;
4. testing the critical role of neural markers at developmental ages using a closed-loop tRNS to improve learning and cognitive outcomes from the training;
5. investigating the safety and tolerability of tRNS.

The investigator's overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in DD.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents with DD (Total Quotient of BDE-2 ≤ 70)
* IQ ≥ 85

Exclusion Criteria:

* Having a comorbidity with an important medical conditions;
* Having neurological diseases;
* Having Epilepsy o family history of epilepsy;
* Receiving a treatment for DD in the previous three months before the baseline screening;

Primary outcomes:
measure: Number Line
timeFrame: immediately after the intervention, one week and three months after the intervention
Secondary outcomes:
measure: Total Quotient
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Numerical Quotient
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Calculation Quotient
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Number Sense Quotient
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Mental multiplications and additions
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Tempo Test Rekenen
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Geometric Puzzle
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Math computerized task
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Motivation and study strategies Questionnaire
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Math Anxiety Questionnaire
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Sleep quality
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Parental stress
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Emotional/behavioural problems
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Math improvement at school
timeFrame: three months after the intervention
measure: Theta/Beta ratio
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Verbal and visuo-spatial working-memory
timeFrame: immediately after the intervention, one week and three months after the intervention
measure: Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
timeFrame: immediately after the intervention, one week and three months after the intervention
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Bambino Gesù Hospital and Research Institute
Study officials:
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