Attention Deficit Hyperactivity DisorderNAADHDNCT01968512
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder
A study testing Transcranial Direct Current Stimulation in people with Attention Deficit Hyperactivity Disorder, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the adaptation of inhibitory control. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Apr 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signature of the informed consent;
- Diagnosis of Attention Deficit Hyperactivity Disorder based on DSM-IV-TR and Adult Self-Report Scale (ASRS-18);
- Adequate eyesight and hearing (or usual corrective methods such as glasses or hearing aid) that allows performing neuropsychological test and questionnaires;
- Residents in Bahia/Brazil;
- Over 18 years.
Who cannot join
- Major psychiatric disorders such as schizophrenia and bipolar disorder;
- Inability to understand the questionnaires used or illiterate;
- Abuse of psychoactive substances, except nicotine and caffeine, in the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder: Contribution of the Transcranial Direct Current Stimulation in Control Inhibitory.
Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the adaptation of inhibitory control.
Read the detailed description
- Assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs in patients with ADHD, using quantitative electroencephalography;
- Study the contribution of transcranial direct current stimulation compared with sham in the adequacy of inhibitory control in ADHD patients through neuropsychological test-Go/No Go;
- Assessing the efficacy of tDCS in neurobiological parameters evidenced by quantitative EEG in patients with ADHD;
- Perform the Reconstruction of the Functional Brain Network of each subject based on the quantitative EEG data through computational and mathematical modeling;
- Register indicators of quality of life in adults with Attention Deficit Hyperactivity Disorder through the Quality of Life Questionnaire for Adults with ADHD (AAQoL).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Transcranial Direct Current Stimulation, Sham
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD);, Transcranial Direct Current Stimulation (tDCS);, Control Inhibitory;, Quantitative electroencephalography;, Functional Brain Network;, Go/No Go test.
- 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.
Transcranial Direct Current StimulationDevice
Also called tDCS
This technique consists in the use of low voltage electric current to increase or reduce neuronal excitability in the area stimulated. This is a non-invasive and safe intervention having infrequent and insignificant side effects characterized by mild local discomfort, itching, tingling and/or headache of short term.
ShamDevice
Same character of Transcranial Direct Current Stimulation but without current
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Subjects will undergo to Transcranial Direct Current Stimulation with anode in left dorsolateral prefrontal cortex and cathode in right supra orbicular region. The stimulus will be 1mA for 20 minutes. Receives: Device: Transcranial Direct Current Stimulation |
| TDCS-Sham | Sham comparator | Subjects will undergo to procedure similar to the Transcranial Direct Current Stimulation with anode in dorsolateral prefrontal cortex and left cathode region supraorbicular right. They will receive a stimulus of 1mA only in initial 30 seconds and it will change the electrical charge for 0mA after this time, however the electrodes will be kept for 20 minutes as the active arm. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative electroencephalography
Quantitative electroencephalography to assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs.
Measured: During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS
Secondary outcomes (1)
Functional Brain Network
Functional Brain Network based on the quantitative EEG data through computational and mathematical modeling. During the only day of the assessment, we will do it before (we will get this information from EEG recording during 8 minutes before do the stimulation) and after tDCS(we will get this information from EEG recording during 8 minutes after the stimulation).
Measured: During the only day of the assessment, we will do it before and after tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Pondé de Sena, Federal University of Bahia
- Investigators
- Eduardo P de Sena, PhD, Principal investigator, Federal University of BahiaCamila S Cosmo, PhD student, Study director, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968512
- Sponsor's protocol ID
- 285.841
- Acronym
- NAADHD
- Status last verified
- Apr 2014
- First submitted
- 29 Jul 2013
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cosmo C, Ferreira C, Miranda JG, do Rosario RS, Baptista AF, Montoya P, de Sena EP. Spreading Effect of tDCS in Individuals with Attention-Deficit/Hyperactivity Disorder as Shown by Functional Cortical Networks: A Randomized, Double-Blind, Sham-Controlled Trial. Front Psychiatry. 2015 Aug 4;6:111. doi: 10.3389/fpsyt.2015.00111. eCollection 2015.
PubMed 26300790Cosmo C, Baptista AF, de Araujo AN, do Rosario RS, Miranda JG, Montoya P, de Sena EP. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder. PLoS One. 2015 Aug 12;10(8):e0135371. doi: 10.1371/journal.pone.0135371. eCollection 2015.
PubMed 26267861Cosmo C, Baptista AF, de Sena EP. Contribution of transcranial direct current stimulation on inhibitory control to assess the neurobiological aspects of attention deficit hyperactivity disorder: randomized controlled trial. JMIR Res Protoc. 2015 May 18;4(2):e56. doi: 10.2196/resprot.4138.
PubMed 25986784
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder: Contribution of the Transcranial Direct Current Stimulation in Control Inhibitory.
- ClinicalTrials.gov ID
- NCT01968512
- Acronym / sponsor ID
- NAADHD / 285.841
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD);, Transcranial Direct Current Stimulation (tDCS);, Control Inhibitory;, Quantitative electroencephalography;, Functional Brain Network;, Go/No Go test.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Oct 2013 (estimated)
- 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.
Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the adaptation of inhibitory control.
Detailed description
- Assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs in patients with ADHD, using quantitative electroencephalography;
- Study the contribution of transcranial direct current stimulation compared with sham in the adequacy of inhibitory control in ADHD patients through neuropsychological test-Go/No Go;
- Assessing the efficacy of tDCS in neurobiological parameters evidenced by quantitative EEG in patients with ADHD;
- Perform the Reconstruction of the Functional Brain Network of each subject based on the quantitative EEG data through computational and mathematical modeling;
- Register indicators of quality of life in adults with Attention Deficit Hyperactivity Disorder through the Quality of Life Questionnaire for Adults with ADHD (AAQoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: Transcranial Direct Current StimulationSubjects will undergo to Transcranial Direct Current Stimulation with anode in left dorsolateral prefrontal cortex and cathode in right supra orbicular region. The stimulus will be 1mA for 20 minutes. |
| TDCS-Sham | Sham comparator | Device: ShamSubjects will undergo to procedure similar to the Transcranial Direct Current Stimulation with anode in dorsolateral prefrontal cortex and left cathode region supraorbicular right. They will receive a stimulus of 1mA only in initial 30 seconds and it will change the electrical charge for 0mA after this time, however the electrodes will be kept for 20 minutes as the active arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signature of the informed consent;
- Diagnosis of Attention Deficit Hyperactivity Disorder based on DSM-IV-TR and Adult Self-Report Scale (ASRS-18);
- Adequate eyesight and hearing (or usual corrective methods such as glasses or hearing aid) that allows performing neuropsychological test and questionnaires;
- Residents in Bahia/Brazil;
- Over 18 years.
Key exclusion criteria (3 listed)
- Major psychiatric disorders such as schizophrenia and bipolar disorder;
- Inability to understand the questionnaires used or illiterate;
- Abuse of psychoactive substances, except nicotine and caffeine, in the last 12 months.
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 |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSThis technique consists in the use of low voltage electric current to increase or reduce neuronal excitability in the area stimulated. This is a non-invasive and safe intervention having infrequent and insignificant side effects characterized by mild local discomfort, itching, tingling and/or headache of short term. | Device | Transcranial Direct Current Stimulation |
| ShamSame character of Transcranial Direct Current Stimulation but without current | Device | TDCS-Sham |
Primary outcome
Quantitative electroencephalography
Time frame: During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS
Quantitative electroencephalography to assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs.
1 secondary outcome
Functional Brain Network
Time frame: During the only day of the assessment, we will do it before and after tDCS
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 1 May 2014.
- Derived from this study: PubMed 26300790Cosmo C, Ferreira C, Miranda JG, do Rosario RS, Baptista AF, Montoya P, de Sena EP. Spreading Effect of tDCS in Individuals with Attention-Deficit/Hyperactivity Disorder as Shown by Functional Cortical Networks: A Randomized, Double-Blind, Sham-Controlled Trial. Front Psychiatry. 2015 Aug 4;6:111. doi: 10.3389/fpsyt.2015.00111. eCollection 2015.
- Derived from this study: PubMed 26267861Cosmo C, Baptista AF, de Araujo AN, do Rosario RS, Miranda JG, Montoya P, de Sena EP. A Randomized, Double-Blind, Sham-Controlled Trial of Transcranial Direct Current Stimulation in Attention-Deficit/Hyperactivity Disorder. PLoS One. 2015 Aug 12;10(8):e0135371. doi: 10.1371/journal.pone.0135371. eCollection 2015.
- Derived from this study: PubMed 25986784Cosmo C, Baptista AF, de Sena EP. Contribution of transcranial direct current stimulation on inhibitory control to assess the neurobiological aspects of attention deficit hyperactivity disorder: randomized controlled trial. JMIR Res Protoc. 2015 May 18;4(2):e56. doi: 10.2196/resprot.4138.
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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.
Eduardo P de Sena, PhD principal investigator
Federal University of Bahia
Camila S Cosmo, PhD student study director
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Attention Deficit Hyperactivity Disorder, run by Federal University of Bahia at 1 site in Brazil.
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 5 inclusion and 3 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 1 May 2014. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Quantitative electroencephalography (time frame: During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS). 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 NCT01968512, which also lists 3 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 1 May 2014.