NCT04242680

tRNS Combined to Cognitive Training in Children With Dyscalculia

Status unknown NA Last updated 10 February 2023

What this trial tests

NA trial testing Brainstim DLPFC in Developmental Dyscalculia in 102 participants. Status unknown.

Timeline

2 September 2019

Primary endpoint
5 January 2024

5 May 2024

Quick facts

Lead sponsor	Bambino Gesù Hospital and Research Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	102
Start date	2 September 2019
Primary completion	5 January 2024
Estimated completion	5 May 2024
Sites	1 location across Italy

Drugs / interventions tested

• Brainstim DLPFC
• Brainstim PPC
• Brainstim Sham
• Cognitive Training

Conditions studied

• Developmental Dyscalculia — all drugs for Developmental Dyscalculia →

Sponsor

Bambino Gesù Hospital and Research Institute

Who can join

Adults 8 to 14, any sex, with Developmental Dyscalculia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Examining tolerability, safety, and blinding in 1032 transcranial electrical stimulation sessions for children and adolescents with neuropsychiatric and neurodevelopmental disorders.
   Battisti A, Lazzaro G, Ursumando L, D'Aiello B, et al · · 2025 · cited 5× · PMID 39915614 · DOI 10.1038/s41598-025-88256-1
2. Boosting Numerical Cognition in Children and Adolescents with Mathematical Learning Disabilities by a Brain-Based Intervention: A Study Protocol for a Randomized, Sham-Controlled Clinical Trial.
   Lazzaro G, Battisti A, Varuzza C, Celestini L, et al · · 2021 · cited 3× · PMID 34682715 · DOI 10.3390/ijerph182010969