Developmental DyscalculiaNCT04242680
tRNS Combined to Cognitive Training in Children With Dyscalculia
A study testing Brainstim DLPFC, Brainstim PPC and Cognitive Training in people with Developmental Dyscalculia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Developmental Dyscalculia
- What is being tested?
- Brainstim DLPFC, Brainstim PPC and Cognitive Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2019to 5 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents with DD (Total Quotient of BDE-2 ≤ 70)
- IQ ≥ 85
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Giulia Lazzaro contact
Italy1 site, 1 recruiting
- Recruiting
Bambino Gesù Hospital and Research Institute
Roma, 00165
Chiara Mennini, 06-68592572, chiara.mennini@opbg.net
Rita Alparone, 06-68592859, rita.alparone@opbg.net
About this study
Official title: Improving Math Deficits in Children With Dyscalculia by tRNS: a Randomized, Double-blind Study
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.
Read the 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:
- testing the critical role of two brain regions (DLPFC or PPC) usually involved in numerical abilities and disrupted in individuals with DD;
- examining the neural changes (using EEG recordings) due to cognitive training without tRNS (Brainstim Sham) and with tRNS (Brainstim DLPFC; Brainstim PPC);
- predicting training outcomes based on math-related skills;
- testing the critical role of neural markers at developmental ages using a closed-loop tRNS to improve learning and cognitive outcomes from the training;
- 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
- Being tested
- Brainstim DLPFC, Brainstim PPC, Brainstim Sham, Cognitive Training
- Keywords
- Children, Adolescents, tRNS, transcranial random noise stimulation, EEG, numerical abilities, neurodevelopmental disorders, non-invasive brain stimulation, transcranial electrical stimulation
- Medical subject headings
- Dyscalculia, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainstim DLPFCDevice
Also called tRNS over bilateral 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.
Brainstim PPCDevice
Also called tRNS over bilateral 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.
Brainstim ShamDevice
Also called Sham tRNS (bilateral DLPFC/bilateral PPC)
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.
Cognitive TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Brainstim DLPFC | Experimental | tRNS over bilateral DLPFC + cognitive training Receives: Device: Brainstim DLPFC; Behavioral: Cognitive Training |
| Brainstim PPC | Experimental | tRNS over bilateral PPC + cognitive training Receives: Device: Brainstim PPC; Behavioral: Cognitive Training |
| Brainstim Sham | Sham comparator | Sham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training Receives: Device: Brainstim Sham; Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Line
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.
Measured: immediately after the intervention, one week and three months after the intervention
Secondary outcomes (17)
Total Quotient
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.
Measured: immediately after the intervention, one week and three months after the intervention
Numerical Quotient
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.
Measured: immediately after the intervention, one week and three months after the intervention
Calculation Quotient
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.
Measured: immediately after the intervention, one week and three months after the intervention
Number Sense Quotient
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.
Measured: immediately after the intervention, one week and three months after the intervention
Mental multiplications and additions
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.
Measured: immediately after the intervention, one week and three months after the intervention
Tempo Test Rekenen
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.
Measured: immediately after the intervention, one week and three months after the intervention
Geometric Puzzle
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.
Measured: immediately after the intervention, one week and three months after the intervention
Math computerized task
The proportion of patients with change in a math computerized task (Math Proc, PEBL) in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Measured: immediately after the intervention, one week and three months after the intervention
Motivation and study strategies Questionnaire
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.
Measured: immediately after the intervention, one week and three months after the intervention
Math Anxiety Questionnaire
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.
Measured: immediately after the intervention, one week and three months after the intervention
Sleep quality
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.
Measured: immediately after the intervention, one week and three months after the intervention
Parental stress
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.
Measured: immediately after the intervention, one week and three months after the intervention
Emotional/behavioural problems
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.
Measured: immediately after the intervention, one week and three months after the intervention
Math improvement at school
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.
Measured: three months after the intervention
Theta/Beta ratio
The proportion of patients with reduction of theta/beta ratio in Brainstim DLPFC and Brainstim PPC than in Brainstim Sham.
Measured: immediately after the intervention, one week and three months after the intervention
Verbal and visuo-spatial working-memory
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.
Measured: immediately after the intervention, one week and three months after the intervention
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
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.
Measured: immediately after the intervention, one week and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start2 Sep 2019
- Primary completion5 Jan 2024 (estimated)
- Study completion5 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Developmental DyscalculiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deny Menghini, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242680
- Sponsor's protocol ID
- 1547_OPBG_2018
- Status last verified
- Feb 2023
- First submitted
- 15 Jan 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Ambrus GG, Paulus W, Antal A. Cutaneous perception thresholds of electrical stimulation methods: comparison of tDCS and tRNS. Clin Neurophysiol. 2010 Nov;121(11):1908-14. doi: 10.1016/j.clinph.2010.04.020. Epub 2010 May 14.
PubMed 20471313Ansari D. Effects of development and enculturation on number representation in the brain. Nat Rev Neurosci. 2008 Apr;9(4):278-91. doi: 10.1038/nrn2334.
PubMed 18334999Arsalidou M, Taylor MJ. Is 2+2=4? Meta-analyses of brain areas needed for numbers and calculations. Neuroimage. 2011 Feb 1;54(3):2382-93. doi: 10.1016/j.neuroimage.2010.10.009. Epub 2010 Oct 12.
PubMed 20946958Butterworth B. Foundational numerical capacities and the origins of dyscalculia. Trends Cogn Sci. 2010 Dec;14(12):534-41. doi: 10.1016/j.tics.2010.09.007.
PubMed 20971676Butterworth B, Varma S, Laurillard D. Dyscalculia: from brain to education. Science. 2011 May 27;332(6033):1049-53. doi: 10.1126/science.1201536.
PubMed 21617068Cantlon JF, Brannon EM, Carter EJ, Pelphrey KA. Functional imaging of numerical processing in adults and 4-y-old children. PLoS Biol. 2006 May;4(5):e125. doi: 10.1371/journal.pbio.0040125. Epub 2006 Apr 11.
PubMed 16594732Cappelletti M, Gessaroli E, Hithersay R, Mitolo M, Didino D, Kanai R, Cohen Kadosh R, Walsh V. Transfer of cognitive training across magnitude dimensions achieved with concurrent brain stimulation of the parietal lobe. J Neurosci. 2013 Sep 11;33(37):14899-907. doi: 10.1523/JNEUROSCI.1692-13.2013.
PubMed 24027289Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.
PubMed 24064065
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Math Deficits in Children With Dyscalculia by tRNS: a Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT04242680
- Acronym / sponsor ID
- 1547_OPBG_2018
- Conditions
- Developmental Dyscalculia
- Keywords
- Children, Adolescents, tRNS, transcranial random noise stimulation, EEG, numerical abilities, neurodevelopmental disorders, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 5 Jan 2024 (estimated)
- Study completion
- 5 May 2024 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- testing the critical role of two brain regions (DLPFC or PPC) usually involved in numerical abilities and disrupted in individuals with DD;
- examining the neural changes (using EEG recordings) due to cognitive training without tRNS (Brainstim Sham) and with tRNS (Brainstim DLPFC; Brainstim PPC);
- predicting training outcomes based on math-related skills;
- testing the critical role of neural markers at developmental ages using a closed-loop tRNS to improve learning and cognitive outcomes from the training;
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brainstim DLPFC | Experimental | Device: Brainstim DLPFC, Behavioral: Cognitive TrainingtRNS over bilateral DLPFC + cognitive training |
| Brainstim PPC | Experimental | Device: Brainstim PPC, Behavioral: Cognitive TrainingtRNS over bilateral PPC + cognitive training |
| Brainstim Sham | Sham comparator | Device: Brainstim Sham, Behavioral: Cognitive TrainingSham tRNS (bilateral DLPFC/bilateral PPC) + cognitive training |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children and adolescents with DD (Total Quotient of BDE-2 ≤ 70)
- IQ ≥ 85
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brainstim DLPFCAlso: tRNS over bilateral DLPFCThe 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 DLPFC |
| Brainstim PPCAlso: tRNS over bilateral PPCThe 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 PPC |
| Brainstim ShamAlso: Sham tRNS (bilateral DLPFC/bilateral PPC)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. | Device | Brainstim Sham |
| Cognitive TrainingA 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). | Behavioural | Brainstim DLPFC, Brainstim PPC, Brainstim Sham |
Primary outcome
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.
17 secondary outcomes
Total Quotient
Time frame: immediately after the intervention, one week and three months after the intervention
Numerical Quotient
Time frame: immediately after the intervention, one week and three months after the intervention
Calculation Quotient
Time frame: immediately after the intervention, one week and three months after the intervention
Number Sense Quotient
Time frame: immediately after the intervention, one week and three months after the intervention
Mental multiplications and additions
Time frame: immediately after the intervention, one week and three months after the intervention
Tempo Test Rekenen
Time frame: immediately after the intervention, one week and three months after the intervention
Geometric Puzzle
Time frame: immediately after the intervention, one week and three months after the intervention
Math computerized task
Time frame: immediately after the intervention, one week and three months after the intervention
Motivation and study strategies Questionnaire
Time frame: immediately after the intervention, one week and three months after the intervention
Math Anxiety Questionnaire
Time frame: immediately after the intervention, one week and three months after the intervention
Sleep quality
Time frame: immediately after the intervention, one week and three months after the intervention
Parental stress
Time frame: immediately after the intervention, one week and three months after the intervention
Emotional/behavioural problems
Time frame: immediately after the intervention, one week and three months after the intervention
Math improvement at school
Time frame: three months after the intervention
Theta/Beta ratio
Time frame: immediately after the intervention, one week and three months after the intervention
Verbal and visuo-spatial working-memory
Time frame: immediately after the intervention, one week and three months after the intervention
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Time frame: immediately after the intervention, one week and three months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- BackgroundAPA (2013). Diagnostic and statistical manual of mental disorders: DSM 5. Washington, DC: American Psychiatric Association.
- BackgroundBaroody, 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.
- BackgroundBelacchi, C., Scalisi, T.G., Cannoni, E. e Cornoldi, C. (2008). Matrici Progressive di Raven Forma
- BackgroundBiancardi, 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.
- BackgroundCornoldi, C., Colpo, G. (2012). Prove di Lettura MT per la Scuola Elementare-2, Firenze, Organizzazioni Speciali.
- BackgroundLehto, J.E. et al. (2003). Dimensions of executive functioning: Evidence from children. British Journal of Developmental Psychology, 21, 59-80.
- BackgroundSartori, G., Job, R., Tressoldi, PE. (2007). DDE-2. Batteria per la valutazione della dislessia e della disortografia evolutiva, Firenze, Organizzazioni Speciali.
- Results publication: PubMed 20471313Ambrus GG, Paulus W, Antal A. Cutaneous perception thresholds of electrical stimulation methods: comparison of tDCS and tRNS. Clin Neurophysiol. 2010 Nov;121(11):1908-14. doi: 10.1016/j.clinph.2010.04.020. Epub 2010 May 14.
- Results publication: PubMed 18334999Ansari D. Effects of development and enculturation on number representation in the brain. Nat Rev Neurosci. 2008 Apr;9(4):278-91. doi: 10.1038/nrn2334.
- Results publication: PubMed 20946958Arsalidou M, Taylor MJ. Is 2+2=4? Meta-analyses of brain areas needed for numbers and calculations. Neuroimage. 2011 Feb 1;54(3):2382-93. doi: 10.1016/j.neuroimage.2010.10.009. Epub 2010 Oct 12.
- Results publication: PubMed 20971676Butterworth B. Foundational numerical capacities and the origins of dyscalculia. Trends Cogn Sci. 2010 Dec;14(12):534-41. doi: 10.1016/j.tics.2010.09.007.
- Results publication: PubMed 21617068Butterworth B, Varma S, Laurillard D. Dyscalculia: from brain to education. Science. 2011 May 27;332(6033):1049-53. doi: 10.1126/science.1201536.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulia Lazzaro contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainstim DLPFC, Brainstim PPC and Cognitive Training in people with Developmental Dyscalculia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deny Menghini (06.6859. 2875, deny.menghini@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number Line (time frame: immediately after the intervention, one week and three months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242680, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.