NCT04242680

tRNS Combined to Cognitive Training in Children With Dyscalculia

Improving Math Deficits in Children With Dyscalculia by tRNS: a Randomized, Double-blind Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Developmental Dyscalculia

Interventions

Type	Name	Description
DEVICE	Brainstim DLPFC	The active tRNS will be delivered to bilateral DLPFC for five consecutive days for two weeks for a total of ten days. tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left and right DLPFC, F3 and F4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training). Stimulation intensity will be set at 0.75 milliampere (mA) (100-500 Hz), the duration of stimulation will be 20 min.
DEVICE	Brainstim PPC	The active tRNS will be delivered to bilateral PPC for five consecutive days for two weeks for a total of ten days. tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left and right PPC, P3 and P4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training). Stimulation intensity will be set at 0.75mA (100-500 Hz), the duration of stimulation will be 20 min.
DEVICE	Brainstim Sham	The same electrode placement will be used as in the stimulation conditions (Brainstim DLPFC or Brainstim PPC), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held five consecutive days for two weeks for a total of ten days.
BEHAVIORAL	Cognitive Training	A cognitive training (Vektor; Nemmi et al., 2016) will be adiministered concomitantly to Brainstim DLPFC, Brainstim PPC, Brainstim Sham for 20 min. The training consisted of math exercises (number line, calculations) and math-related exercises (visuo-spatial working memory, mental rotation).

Timeline

• Start date: 2019-09-02
• Primary completion: 2024-01-05
• Completion: 2024-05-05
• First posted: 2020-01-27
• Last updated: 2023-02-10

Locations

1 site across 1 country: Italy