tRNS Combined to Cognitive Training in Children With Dyscalculia

Bambino Gesù Hospital and Research Institute

Status: Enrolling

Conditions: Developmental Dyscalculia

Treatments: Device: Brainstim Sham; Device: Brainstim DLPFC; Behavioral: Cognitive Training; Device: Brainstim PPC

Study type: Interventional

Funder types: Other

Identifiers

NCT04242680

1547_OPBG_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 3 patient groups

Brainstim DLPFC

Experimental group

Description:

tRNS over bilateral DLPFC + cognitive training

Treatment:

Device: Brainstim DLPFC

Behavioral: Cognitive Training

Brainstim PPC

Experimental group

Description:

tRNS over bilateral PPC + cognitive training

Treatment:

Device: Brainstim PPC

Behavioral: Cognitive Training

Brainstim Sham

Sham Comparator group

Description:

Sham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training

Treatment:

Device: Brainstim Sham

Behavioral: Cognitive Training