The Effects of Methylphenidate and Non-invasive Brain Stimulation on Inhibitory Control in Children With ADHD

Bambino Gesù Hospital and Research Institute

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Device: sham tDCS; Device: anodal tDCS; Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT04964427

2185_2020_OPBG

Details and patient eligibility

About

The aim of this study is comparing the effects of non-pharmacological intervention (transcranial Direct Current Stimulation, tDCS) with those of drug (methylphenidate, MPH) administration in children and adolescents with ADHD.

The investigators hypothesized that tDCS would improve inhibitory control and visuo-spatial working memory as well as MPH.

Full description

A sham controlled within-subjects study design will be conducted. Clinical eligibility screening will be completed at baseline. All participants will undergo an extensive neuropsychiatric evaluation in which developmental neuropsychiatrists and psychologists will evaluate the cognitive and the adaptive level, the severity of ADHD symptoms, and the presence of comorbid psychiatric disorders. After completing baseline assessment (T0), participants will be exposure to 3 conditions with an intersession-interval of 24h (T1, T2, T3): A) a single administration of 1 milliampere (mA) anodal tDCS session over the dorsolateral prefrontal cortex (DLPFC); B) a single administration of 1 mA sham tDCS session over the DLPFC; C) a single administration of immediate release MPH (Ritalin®), in accordance with the National Institute for Clinical Excellence (NICE) guidelines for ADHD (NICE, 2000). The order of the conditions will be counterbalanced across participants. After recruitment, the participants will be assigned to one of the 6 possible combinations of conditions (ABC, ACB, BAC, BCA, CBA, or CAB). The assignment will be according to a randomization order generated by a computer. The randomization information will be maintained by an independent researcher until data collection is completed. Participants will be tested on inhibitory control, by the Stop Signal Task (SST) and on working memory, by the N-Back Task, at baseline (T0), during tDCS administration (after 10 minutes of anodal and sham conditions) and after 1 hour of MPH administration. To verify that carry-over effects will not occur, the SST and the N-Back Task will be performed before each session (T1, T2, T3) and results will be compared with those obtained at baseline (T0). If the participant will not return to baseline level, another evaluation will be administered at least after two hours and, again, until participant's performance will return to baseline. Participants and parents will be blinded to tDCS conditions allocation. The tDCS will be carried out with a BrainStim stimulator.

Enrollment: 26 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Criteria: Inclusion Criteria:

• Patients must receive a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) oriented diagnosis of ADHD and need drug treatment for the severity of symptoms;
• Intelligent Quotient (IQ) > 85;

Exclusion Criteria:

• Presence of Autism Spectrum Disorders;
• Presence of Mood Disorders;
• Previous/current diagnosis of neurological conditions (i.e. epilepsy, neurodegenerative diseases);
• Presence of Genetic Syndromes;
• Presence of basal medical conditions (i.e. heart, kidney or liver diseases) which may exclude the possibility to administer MPH.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 6 patient groups

anodal tDCS- sham tDCS- MPH

Experimental group

Description:

(A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3

Treatment:

Drug: Methylphenidate

Device: anodal tDCS

Device: sham tDCS

anodal tDCS- MPH- sham tDCS

Experimental group

Description:

(A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3

Treatment:

Drug: Methylphenidate

Device: anodal tDCS

Device: sham tDCS

sham tDCS- anodal tDCS- MPH

Experimental group

Description:

(B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3

Treatment:

Drug: Methylphenidate

Device: anodal tDCS

Device: sham tDCS

sham tDCS- MPH- anodal tDCS

Experimental group

Description:

(B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3

Treatment:

Drug: Methylphenidate

Device: anodal tDCS

Device: sham tDCS

MPH- anodal tDCS- sham tDCS

Experimental group

Description:

(C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3

Treatment:

Drug: Methylphenidate

Device: anodal tDCS

Device: sham tDCS

MPH- sham tDCS- anodal tDCS

Experimental group

Description:

(C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3

Treatment:

Drug: Methylphenidate

Device: anodal tDCS

Device: sham tDCS