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tRNS Combined to Cognitive Training in Children With Dyscalculia

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ClinicalTrials.gov Identifier: NCT04242680
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Deny Menghini, Bambino Gesù Hospital and Research Institute

Study Description
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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.


Condition or disease Intervention/treatment Phase
Developmental Dyscalculia Device: Brainstim DLPFC Device: Brainstim PPC Device: Brainstim Sham Behavioral: Cognitive Training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Math Deficits in Children With Dyscalculia by tRNS: a Randomized, Double-blind Study
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : September 2, 2022
Estimated Study Completion Date : November 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Brainstim DLPFC
tRNS over bilateral DLPFC + cognitive training
 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.

Other Name: tRNS over bilateral DLPFC

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).
Experimental: Brainstim PPC
tRNS over bilateral PPC + cognitive training
 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.

Other Name: tRNS over bilateral PPC

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).
Sham Comparator: Brainstim Sham
Sham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training
 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.
Other Name: Sham tRNS (bilateral DLPFC/bilateral PPC)

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).


Outcome Measures
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Primary Outcome Measures :
  1. Number Line [ Time Frame: 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 :
  1. Total Quotient [ Time Frame: 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.

  2. Numerical Quotient [ Time Frame: 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.

  3. Calculation Quotient [ Time Frame: 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.

  4. Number Sense Quotient [ Time Frame: 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.

  5. Mental multiplications and additions [ Time Frame: 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.

  6. Tempo Test Rekenen [ Time Frame: 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.

  7. Geometric Puzzle [ Time Frame: 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.

  8. Math computerized task [ Time Frame: 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.

  9. Motivation and study strategies Questionnaire [ Time Frame: 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.

  10. Math Anxiety Questionnaire [ Time Frame: 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.

  11. Sleep quality [ Time Frame: 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.

  12. Parental stress [ Time Frame: 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.

  13. Emotional/behavioural problems [ Time Frame: 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.

  14. Math improvement at school [ Time Frame: 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.

  15. Theta/Beta ratio [ Time Frame: 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.

  16. Verbal and visuo-spatial working-memory [ Time Frame: 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.

  17. Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242680


Contacts
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Contact: Deny Menghini 06.6859. 2875 deny.menghini@opbg.net
Contact: Giulia Lazzaro giulia.lazzaro@opbg.net

Locations
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Italy
Bambino Gesù Hospital and Research Institute Recruiting
Roma, Italy, 00165
Contact: Chiara Mennini    06-68592572    chiara.mennini@opbg.net   
Contact: Rita Alparone    06-68592859    rita.alparone@opbg.net   
Principal Investigator: Deny Menghini         
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Korkman, M., Kirk, U., Kemp, S. (2011). NEPSY-II. Giunti, OS.

Other Publications:
APA (2013). Diagnostic and statistical manual of mental disorders: DSM 5. Washington, DC: American Psychiatric Association.
Baroody, AJ., Tiilikainen, SH. Two perspectives on addition development. In: Baroody AJ, Dowker A, editors. The development of arithmetic concepts and skills: The construction of adaptive expertise. Erlbaum; Mahwah, NJ: 2003. pp. 75-125.
Belacchi, C., Scalisi, T.G., Cannoni, E. e Cornoldi, C. (2008). Matrici Progressive di Raven Forma
Biancardi, A., Bachmann, C., Nicoletti, C. (2016) BDE 2 - Batteria discalculia evolutiva Test per la diagnosi dei disturbi dell'elaborazione numerica e del calcolo in età evolutiva - 8-13 anni.
Cornoldi, C., Colpo, G. (2012). Prove di Lettura MT per la Scuola Elementare-2, Firenze, Organizzazioni Speciali.
Lehto, J.E. et al. (2003). Dimensions of executive functioning: Evidence from children. British Journal of Developmental Psychology, 21, 59-80.
Sartori, G., Job, R., Tressoldi, PE. (2007). DDE-2. Batteria per la valutazione della dislessia e della disortografia evolutiva, Firenze, Organizzazioni Speciali.

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Responsible Party: Deny Menghini, Clinical Psychologist, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT04242680    
Other Study ID Numbers: 1547_OPBG_2018
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deny Menghini, Bambino Gesù Hospital and Research Institute:
Children
Adolescents
tRNS
transcranial random noise stimulation
EEG
 numerical abilities
neurodevelopmental disorders
non-invasive brain stimulation
transcranial electrical stimulation
Additional relevant MeSH terms:
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Dyscalculia
Developmental Disabilities
Learning Disorders
Communication Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders