The Effects of Methylphenidate and Non-invasive Brain Stimulation on Inhibitory Control in Children With ADHD
NCT ID: NCT04964427
Last Updated: 2023-02-08
Study Results
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Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2021-02-08
2022-11-02
Brief Summary
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The investigators hypothesized that tDCS would improve inhibitory control and visuo-spatial working memory as well as MPH.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
* a single dose of immediate release MPH (Ritalin®) administered according to the AIFA and NICE guidelines for ADHD;
* a single 1 mA anodal tDCS session over the DLPFC for 20 min
* a single session of sham tDCS over the DLPFC for 30s at the beginning and end of the tDCS session.
The order of administration of the conditions will be counterbalanced between the participants and the conditions will be spaced apart from an interval of 24 hours.
TREATMENT
DOUBLE
Study Groups
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anodal tDCS- sham tDCS- MPH
(A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3
Methylphenidate
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 tDCS
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 tDCS
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.
anodal tDCS- MPH- sham tDCS
(A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3
Methylphenidate
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 tDCS
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 tDCS
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.
sham tDCS- anodal tDCS- MPH
(B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3
Methylphenidate
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 tDCS
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 tDCS
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.
sham tDCS- MPH- anodal tDCS
(B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3
Methylphenidate
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 tDCS
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 tDCS
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.
MPH- anodal tDCS- sham tDCS
(C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3
Methylphenidate
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 tDCS
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 tDCS
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.
MPH- sham tDCS- anodal tDCS
(C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3
Methylphenidate
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 tDCS
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 tDCS
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.
Interventions
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Methylphenidate
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 tDCS
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 tDCS
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intelligent Quotient (IQ) \> 85;
Exclusion Criteria
* 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.
8 Years
13 Years
ALL
No
Sponsors
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Bambino Gesù Hospital and Research Institute
OTHER
Responsible Party
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Deny Menghini
Principal Investigator
Locations
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Bambino Gesù Hospital and Research Institute
Roma, , Italy
Countries
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References
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2185_2020_OPBG
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Identifier Source: org_study_id
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