CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Methylphenidate +2 moredrug
Likely dose
Methylphenidate 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04964427
NCT04964427N/ACompleted

The Effects of Methylphenidate (MPH) and Non-invasive Brain Stimulation (tDCS) on Inhibitory Control Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Bambino Gesù Hospital and Research Institute·interventional·Posted Jul 16, 2021·Updated Feb 8, 2023

In Brief

A clinical study evaluating Methylphenidate, anodal tDCS, and 1 other intervention for Attention Deficit Hyperactivity Disorder. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 16, 2021
Enrollment StartFeb 8, 2021
Primary CompletionOct 2, 2022
Study CompletionNov 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.0 years ago

Interventions

Methylphenidatedrug

A single dose of 5-10 mg of immediate release MPH (Ritalin®) will be administered in line with NICE and AIFA (Agenzia Italiana del Farmaco) guidelines for ADHD treatment.

anodal tDCSdevice

Anodal electrode will be positioned over the left dlPFC, according to the 10-20 EEG on the sites corresponding F3, whereas the reference electrode will be placed above the contralateral supraorbital area, corresponding to Fp2. In the active tDCS condition, the current will increase slowly during the first 30 seconds to 1 mA (ramp-up) and, at the end of the stimulation, the current will decrease slowly to 0 mA during the last 30 seconds (ramp-down). Between the ramp-up and ramp-down constant current will be delivered for 20 minutes, with a density of 0.04 mA/cm2.

sham tDCSdevice

In the sham tDCS condition, the stimulation will be delivered by using the same active tDCS montage, respectively left-anodal dlPFC and right-reference electrode over Fp2. Stimulation intensity will be set at 1 mA, but the current will be applied for 30 seconds and will be ramped down without the participants' awareness.