- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01968512
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder (NAADHD)
April 30, 2014 updated by: Eduardo Pondé de Sena, Federal University of Bahia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bahia
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Salvador, Bahia, Brazil, 40000-000
- Federal University of Bahia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Transcranial Direct Current Stimulation
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.
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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.
Other Names:
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Sham Comparator: TDCS-Sham
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.
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Same character of Transcranial Direct Current Stimulation but without current
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Quantitative electroencephalography to assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs.
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During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Brain Network
Time Frame: During the only day of the assessment, we will do it before and after tDCS
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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).
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During the only day of the assessment, we will do it before and after tDCS
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Go/No Go test
Time Frame: During the only day of the assessment, we will do it before and after tDCS
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Neuropsychological test to assess the adequacy of inhibitory control.
During the only day of the assessment, we will do it before (after 5 minutes of EEG recording, we will start the Go/No go test keeping the EEG recording for 3 minutes, and after it we will do tDCS) and after the tDCS (after 5 minutes of EEG recording, we will restart the Go/No go test keeping the EEG recording for 3 minutes).
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During the only day of the assessment, we will do it before and after tDCS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eduardo P de Sena, PhD, Federal University of Bahia
- Study Director: Camila S Cosmo, PhD student, Federal University of Bahia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Cosmo 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.
- Cosmo 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
July 29, 2013
First Submitted That Met QC Criteria
October 18, 2013
First Posted (Estimate)
October 24, 2013
Study Record Updates
Last Update Posted (Estimate)
May 1, 2014
Last Update Submitted That Met QC Criteria
April 30, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 285.841
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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