tRNS Combined to Cognitive Training in Children With Dyscalculia

Not Applicable

Recruiting

• Conditions: Developmental Dyscalculia
• Interventions: Device: Brainstim DLPFC; Device: Brainstim Sham; Device: Brainstim PPC; Behavioral: Cognitive Training

• Registration Number: NCT04242680
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

Study Timeline

• Study Start: 2019-09-02
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10
• Primary Completion: 2024-01-05
• Study Completion: 2024-05-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brainstim DLPFC	Brainstim DLPFC	tRNS over bilateral DLPFC + cognitive training
Brainstim PPC	Cognitive Training	tRNS over bilateral PPC + cognitive training
Brainstim Sham	Brainstim Sham	Sham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training
Brainstim Sham	Cognitive Training	Sham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training
Brainstim DLPFC	Cognitive Training	tRNS over bilateral DLPFC + cognitive training
Brainstim PPC	Brainstim PPC	tRNS over bilateral PPC + cognitive training

Primary Outcome Measures

Name	Time	Method
Number Line	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change of at least 1 SD in the "number line task" of the Diagnostic battery for Dyscalculia (BDE 2, Biancardi et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.

Secondary Outcome Measures

Name	Time	Method
Total Quotient	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the "Total Quotient" of the BDE 2 (Biancardi et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Geometric Puzzle	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the total scores of the Geometric Puzzle (Nepsy II, Korkman et al., 2011) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Mental multiplications and additions	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the Mental Multiplications and Mental Additions tasks of the Diagnostic battery for Dyscalculia 1 (Biancardi et al., 2004) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Math computerized task	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in a math computerized task (Math Proc, PEBL) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Sleep quality	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change (lower score means better outcome) in the Sleep Disturbance Scale for Children (SDSC, Bruni et al., 1996) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the questionnaire of safety and tolerability (Questionnaire of adverse effect; Brunoni et al., 2011) in Brainstim DLPFC and Brainstim PPC will be the same than in Brainstim Sham.
Tempo Test Rekenen	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the total scores of the Tempo Test Rekenen (De Vos, 1992) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Motivation and study strategies Questionnaire	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change (lower score means better outcome) in the Motivation and study strategies Questionnaire from 8 to 15 ages (AMOS 8-15, Cornoldi et al., 2005) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Math Anxiety Questionnaire	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change (lower score means better outcome) in the Math Anxiety Questionnaire (MARS, Saccani and Cornoldi, 2005) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Numerical Quotient	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the "Numerical Quotient" of the BDE 2 (Biancardi et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Calculation Quotient	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the "Calculation Quotient" of the BDE 2 (Biancardi et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Number Sense Quotient	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the "Number Sense Quotient" of the BDE 2 (Biancardi et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Parental stress	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change (higher score means better outcome) in the Parent Stress Index (PSI, Guarino et al., 2014) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Emotional/behavioural problems	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change (lower score means better outcome) in the Cross-symptom assessment scales of the Kiddie-Sads- present and lifetime version-Diagnostic and Statistical Manual of Mental Disorders 5 (K-SADS- DSM-5, Kaufman et al., 2016) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Math improvement at school	three months after the intervention	The proportion of patients with change in math markers in the transcript (scale from 0 to 10, where 10 is the best level and 0 the worst) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Theta/Beta ratio	immediately after the intervention, one week and three months after the intervention	The proportion of patients with reduction of theta/beta ratio in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Verbal and visuo-spatial working-memory	immediately after the intervention, one week and three months after the intervention	The proportion of patients with change in the index of verbal and visuo-spatial n-back (more score means better outcome) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.

Trial Locations

Locations (1)

Bambino Gesù Hospital and Research Institute; 🇮🇹 Roma, Italy