Attention Deficit Hyperactivity DisorderNCT04964427
The Effects of Methylphenidate and Non-invasive Brain Stimulation on Inhibitory Control in Children With ADHD
A study testing Methylphenidate and anodal tDCS in people with Attention Deficit Hyperactivity Disorder, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate and anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 8 Feb 2021to 2 Nov 2022
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Methylphenidate (MPH) and Non-invasive Brain Stimulation (tDCS) on Inhibitory Control Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate, anodal tDCS, sham tDCS
- Keywords
- methylphenidate, executive functions, working memory, tDCS, inhibitory control
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
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.
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS- sham tDCS- MPH | Experimental | (A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3 Receives: Drug: Methylphenidate; Device: anodal tDCS; Device: sham tDCS |
| anodal tDCS- MPH- sham tDCS | Experimental | (A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3 Receives: Drug: Methylphenidate; Device: anodal tDCS; Device: sham tDCS |
| sham tDCS- anodal tDCS- MPH | Experimental | (B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3 Receives: Drug: Methylphenidate; Device: anodal tDCS; Device: sham tDCS |
| sham tDCS- MPH- anodal tDCS | Experimental | (B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3 Receives: Drug: Methylphenidate; Device: anodal tDCS; Device: sham tDCS |
| MPH- anodal tDCS- sham tDCS | Experimental | (C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3 Receives: Drug: Methylphenidate; Device: anodal tDCS; Device: sham tDCS |
| MPH- sham tDCS- anodal tDCS | Experimental | (C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3 Receives: Drug: Methylphenidate; Device: anodal tDCS; Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the change in response inhibition measures
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
Measured: immediately after the interventions
Secondary outcomes (2)
evaluate the change in other response inhibition measures
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
Measured: immediately after the interventions
evaluate the change in visuo-spatial working memory measure
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
Measured: immediately after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start8 Feb 2021
- Primary completion2 Oct 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (111)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Crossover
- Model description
- Study participants will receive the three conditions in random order: * 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
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
- NCT04964427
- Sponsor's protocol ID
- 2185_2020_OPBG
- Status last verified
- Feb 2023
- First submitted
- 1 Jul 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adamo N, Hodsoll J, Asherson P, Buitelaar JK, Kuntsi J. Ex-Gaussian, Frequency and Reward Analyses Reveal Specificity of Reaction Time Fluctuations to ADHD and Not Autism Traits. J Abnorm Child Psychol. 2019 Mar;47(3):557-567. doi: 10.1007/s10802-018-0457-z.
PubMed 30027330Adams ZW, Roberts WM, Milich R, Fillmore MT. Does response variability predict distractibility among adults with attention-deficit/hyperactivity disorder? Psychol Assess. 2011 Jun;23(2):427-36. doi: 10.1037/a0022112.
PubMed 21443365Andreou P, Neale BM, Chen W, Christiansen H, Gabriels I, Heise A, Meidad S, Muller UC, Uebel H, Banaschewski T, Manor I, Oades R, Roeyers H, Rothenberger A, Sham P, Steinhausen HC, Asherson P, Kuntsi J. Reaction time performance in ADHD: improvement under fast-incentive condition and familial effects. Psychol Med. 2007 Dec;37(12):1703-15. doi: 10.1017/S0033291707000815. Epub 2007 May 31.
PubMed 17537284Aron AR, Dowson JH, Sahakian BJ, Robbins TW. Methylphenidate improves response inhibition in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2003 Dec 15;54(12):1465-8. doi: 10.1016/s0006-3223(03)00609-7.
PubMed 14675812Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009 Jul 27;1:58. doi: 10.3410/M1-58.
PubMed 20948722Banaschewski T, Coghill D, Santosh P, Zuddas A, Asherson P, Buitelaar J, Danckaerts M, Dopfner M, Faraone SV, Rothenberger A, Sergeant J, Steinhausen HC, Sonuga-Barke EJ, Taylor E. Long-acting medications for the hyperkinetic disorders. A systematic review and European treatment guideline. Eur Child Adolesc Psychiatry. 2006 Dec;15(8):476-95. doi: 10.1007/s00787-006-0549-0. Epub 2006 May 5.
PubMed 16680409Barkley RA, Fischer M, Smallish L, Fletcher K. Young adult outcome of hyperactive children: adaptive functioning in major life activities. J Am Acad Child Adolesc Psychiatry. 2006 Feb;45(2):192-202. doi: 10.1097/01.chi.0000189134.97436.e2.
PubMed 16429090Bedard AC, Martinussen R, Ickowicz A, Tannock R. Methylphenidate improves visual-spatial memory in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2004 Mar;43(3):260-8. doi: 10.1097/00004583-200403000-00006.
PubMed 15076258Bellgrove MA, Hester R, Garavan H. The functional neuroanatomical correlates of response variability: evidence from a response inhibition task. Neuropsychologia. 2004;42(14):1910-6. doi: 10.1016/j.neuropsychologia.2004.05.007.
PubMed 15381021Biederman J, Spencer T. Attention-deficit/hyperactivity disorder (ADHD) as a noradrenergic disorder. Biol Psychiatry. 1999 Nov 1;46(9):1234-42. doi: 10.1016/s0006-3223(99)00192-4.
PubMed 10560028BINDMAN LJ, LIPPOLD OC, REDFEARN JW. THE ACTION OF BRIEF POLARIZING CURRENTS ON THE CEREBRAL CORTEX OF THE RAT (1) DURING CURRENT FLOW AND (2) IN THE PRODUCTION OF LONG-LASTING AFTER-EFFECTS. J Physiol. 1964 Aug;172(3):369-82. doi: 10.1113/jphysiol.1964.sp007425. No abstract available.
PubMed 14199369Boggio PS, Ferrucci R, Mameli F, Martins D, Martins O, Vergari M, Tadini L, Scarpini E, Fregni F, Priori A. Prolonged visual memory enhancement after direct current stimulation in Alzheimer's disease. Brain Stimul. 2012 Jul;5(3):223-230. doi: 10.1016/j.brs.2011.06.006. Epub 2011 Jul 27.
PubMed 21840288Boonstra AM, Kooij JJ, Oosterlaan J, Sergeant JA, Buitelaar JK. Does methylphenidate improve inhibition and other cognitive abilities in adults with childhood-onset ADHD? J Clin Exp Neuropsychol. 2005 Apr;27(3):278-98. doi: 10.1080/13803390490515757.
PubMed 15969353Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PubMed 21320389Buzy WM, Medoff DR, Schweitzer JB. Intra-individual variability among children with ADHD on a working memory task: an ex-Gaussian approach. Child Neuropsychol. 2009 Sep;15(5):441-59. doi: 10.1080/09297040802646991.
PubMed 19184779
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Methylphenidate (MPH) and Non-invasive Brain Stimulation (tDCS) on Inhibitory Control Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT04964427
- Acronym / sponsor ID
- 2185_2020_OPBG
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- methylphenidate, executive functions, working memory, tDCS, inhibitory control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 16 Jul 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Study participants will receive the three conditions in random order: * 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.
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS- sham tDCS- MPH | Experimental | Drug: Methylphenidate, Device: anodal tDCS, Device: sham tDCS(A) anodal tDCS at t1 (B) sham tDCS at t2 (C) MPH at t3 |
| anodal tDCS- MPH- sham tDCS | Experimental | Drug: Methylphenidate, Device: anodal tDCS, Device: sham tDCS(A) anodal tDCS at t1 (C) MPH at t2 (B) sham tDCS at t3 |
| sham tDCS- anodal tDCS- MPH | Experimental | Drug: Methylphenidate, Device: anodal tDCS, Device: sham tDCS(B) sham tDCS at t1 (A) anodal tDCS at t2 (C) MPH at t3 |
| sham tDCS- MPH- anodal tDCS | Experimental | Drug: Methylphenidate, Device: anodal tDCS, Device: sham tDCS(B) sham tDCS at t1 (C) MPH at t2 (A) anodal tDCS at t3 |
| MPH- anodal tDCS- sham tDCS | Experimental | Drug: Methylphenidate, Device: anodal tDCS, Device: sham tDCS(C) MPH at t1 (A) anodal tDCS at t2 (B) sham tDCS at t3 |
| MPH- sham tDCS- anodal tDCS | Experimental | Drug: Methylphenidate, Device: anodal tDCS, Device: sham tDCS(C) MPH at t1 (B) sham tDCS at t2 (A) anodal tDCS at t3 |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| MethylphenidateAlso: RitalinA 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. | Drug | MPH- anodal tDCS- sham tDCS, MPH- sham tDCS- anodal tDCS, anodal tDCS- MPH- sham tDCS, anodal tDCS- sham tDCS- MPH, sham tDCS- MPH- anodal tDCS, sham tDCS- anodal tDCS- MPH |
| anodal tDCSAnodal 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. | Device | MPH- anodal tDCS- sham tDCS, MPH- sham tDCS- anodal tDCS, anodal tDCS- MPH- sham tDCS, anodal tDCS- sham tDCS- MPH, sham tDCS- MPH- anodal tDCS, sham tDCS- anodal tDCS- MPH |
| sham tDCSIn 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. | Device | MPH- anodal tDCS- sham tDCS, MPH- sham tDCS- anodal tDCS, anodal tDCS- MPH- sham tDCS, anodal tDCS- sham tDCS- MPH, sham tDCS- MPH- anodal tDCS, sham tDCS- anodal tDCS- MPH |
Primary outcome
evaluate the change in response inhibition measures
Time frame: 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
2 secondary outcomes
evaluate the change in other response inhibition measures
Time frame: immediately after the interventions
evaluate the change in visuo-spatial working memory measure
Time frame: immediately after the interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Results publication: PubMed 30027330Adamo N, Hodsoll J, Asherson P, Buitelaar JK, Kuntsi J. Ex-Gaussian, Frequency and Reward Analyses Reveal Specificity of Reaction Time Fluctuations to ADHD and Not Autism Traits. J Abnorm Child Psychol. 2019 Mar;47(3):557-567. doi: 10.1007/s10802-018-0457-z.
- Results publication: PubMed 21443365Adams ZW, Roberts WM, Milich R, Fillmore MT. Does response variability predict distractibility among adults with attention-deficit/hyperactivity disorder? Psychol Assess. 2011 Jun;23(2):427-36. doi: 10.1037/a0022112.
- Results publication: PubMed 17537284Andreou P, Neale BM, Chen W, Christiansen H, Gabriels I, Heise A, Meidad S, Muller UC, Uebel H, Banaschewski T, Manor I, Oades R, Roeyers H, Rothenberger A, Sham P, Steinhausen HC, Asherson P, Kuntsi J. Reaction time performance in ADHD: improvement under fast-incentive condition and familial effects. Psychol Med. 2007 Dec;37(12):1703-15. doi: 10.1017/S0033291707000815. Epub 2007 May 31.
- Results publication: PubMed 14675812Aron AR, Dowson JH, Sahakian BJ, Robbins TW. Methylphenidate improves response inhibition in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2003 Dec 15;54(12):1465-8. doi: 10.1016/s0006-3223(03)00609-7.
- Results publication: PubMed 20948722Arul-Anandam AP, Loo C, Sachdev P. Transcranial direct current stimulation - what is the evidence for its efficacy and safety? F1000 Med Rep. 2009 Jul 27;1:58. doi: 10.3410/M1-58.
- Results publication: PubMed 16680409Banaschewski T, Coghill D, Santosh P, Zuddas A, Asherson P, Buitelaar J, Danckaerts M, Dopfner M, Faraone SV, Rothenberger A, Sergeant J, Steinhausen HC, Sonuga-Barke EJ, Taylor E. Long-acting medications for the hyperkinetic disorders. A systematic review and European treatment guideline. Eur Child Adolesc Psychiatry. 2006 Dec;15(8):476-95. doi: 10.1007/s00787-006-0549-0. Epub 2006 May 5.
- Results publication: PubMed 16429090Barkley RA, Fischer M, Smallish L, Fletcher K. Young adult outcome of hyperactive children: adaptive functioning in major life activities. J Am Acad Child Adolesc Psychiatry. 2006 Feb;45(2):192-202. doi: 10.1097/01.chi.0000189134.97436.e2.
- Results publication: PubMed 15076258Bedard AC, Martinussen R, Ickowicz A, Tannock R. Methylphenidate improves visual-spatial memory in children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2004 Mar;43(3):260-8. doi: 10.1097/00004583-200403000-00006.
- Results publication: PubMed 15381021Bellgrove MA, Hester R, Garavan H. The functional neuroanatomical correlates of response variability: evidence from a response inhibition task. Neuropsychologia. 2004;42(14):1910-6. doi: 10.1016/j.neuropsychologia.2004.05.007.
- Results publication: PubMed 10560028Biederman J, Spencer T. Attention-deficit/hyperactivity disorder (ADHD) as a noradrenergic disorder. Biol Psychiatry. 1999 Nov 1;46(9):1234-42. doi: 10.1016/s0006-3223(99)00192-4.
- Results publication: PubMed 14199369BINDMAN LJ, LIPPOLD OC, REDFEARN JW. THE ACTION OF BRIEF POLARIZING CURRENTS ON THE CEREBRAL CORTEX OF THE RAT (1) DURING CURRENT FLOW AND (2) IN THE PRODUCTION OF LONG-LASTING AFTER-EFFECTS. J Physiol. 1964 Aug;172(3):369-82. doi: 10.1113/jphysiol.1964.sp007425. No abstract available.
- Results publication: PubMed 21840288Boggio PS, Ferrucci R, Mameli F, Martins D, Martins O, Vergari M, Tadini L, Scarpini E, Fregni F, Priori A. Prolonged visual memory enhancement after direct current stimulation in Alzheimer's disease. Brain Stimul. 2012 Jul;5(3):223-230. doi: 10.1016/j.brs.2011.06.006. Epub 2011 Jul 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate and anodal tDCS in people with Attention Deficit Hyperactivity Disorder, 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 0 inclusion and 5 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: finished, as of the sponsor's last update on 8 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the change in response inhibition measures (time frame: immediately after the interventions). 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 NCT04964427, which also lists 111 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 8 Feb 2023.