The Effects of Methylphenidate and Non-invasive Brain Stimulation on Inhibitory Control in Children With ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Registration Number
- NCT04964427
- Lead Sponsor
- Bambino Gesù Hospital and Research Institute
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description anodal tDCS- sham tDCS- MPH anodal tDCS (A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3 anodal tDCS- sham tDCS- MPH sham tDCS (A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3 anodal tDCS- MPH- sham tDCS anodal tDCS (A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3 anodal tDCS- MPH- sham tDCS sham tDCS (A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3 sham tDCS- MPH- anodal tDCS sham tDCS (B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3 sham tDCS- anodal tDCS- MPH anodal tDCS (B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3 sham tDCS- anodal tDCS- MPH sham tDCS (B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3 sham tDCS- MPH- anodal tDCS anodal tDCS (B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3 MPH- anodal tDCS- sham tDCS anodal tDCS (C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3 MPH- anodal tDCS- sham tDCS sham tDCS (C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3 MPH- sham tDCS- anodal tDCS anodal tDCS (C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3 MPH- sham tDCS- anodal tDCS sham tDCS (C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3 anodal tDCS- sham tDCS- MPH Methylphenidate (A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3 anodal tDCS- MPH- sham tDCS Methylphenidate (A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3 MPH- sham tDCS- anodal tDCS Methylphenidate (C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3 sham tDCS- anodal tDCS- MPH Methylphenidate (B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3 sham tDCS- MPH- anodal tDCS Methylphenidate (B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3 MPH- anodal tDCS- sham tDCS Methylphenidate (C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3
- Primary Outcome Measures
Name Time Method evaluate the change in response inhibition measures immediately after the interventions Compare Stop Signal Reaction Times in patients with ADHD following the administration of a single anodal tDCS session, a single sham tDCS session and a single dose of MPH
- Secondary Outcome Measures
Name Time Method evaluate the change in visuo-spatial working memory measure immediately after the interventions Compare N-Back Correct Scores of visuo-spatial working memory task in patients with ADHD following the administration of a single anodal tDCS session, a single sham tDCS session and a single dose of MPH
evaluate the change in other response inhibition measures immediately after the interventions Reaction Times and Variability of Reaction Times of SST in patients with ADHD following the administration of a single anodal tDCS session, a single sham tDCS session and a single dose of MPH
Trial Locations
- Locations (1)
Bambino Gesù Hospital and Research Institute
🇮🇹Roma, Italy