Clinical trial NCT01968512: Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder
Official title: Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder: Contribution of the Transcranial Direct Current Stimulation in Control Inhibitory.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 1. 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;
2. 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;
3. Assessing the efficacy of tDCS in neurobiological parameters evidenced by quantitative EEG in patients with ADHD;
4. Perform the Reconstruction of the Functional Brain Network of each subject based on the quantitative EEG data through computational and mathematical modeling;
5. Register indicators of quality of life in adults with Attention Deficit Hyperactivity Disorder through the Quality of Life Questionnaire for Adults with ADHD (AAQoL).

Eligibility criteria: 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.

Primary outcomes:
measure: Quantitative electroencephalography
timeFrame: During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS
Secondary outcomes:
measure: Functional Brain Network
timeFrame: During the only day of the assessment, we will do it before and after tDCS
Other outcomes:
measure: Go/No Go test
timeFrame: During the only day of the assessment, we will do it before and after tDCS
Locations:
city: Salvador
country: Brazil
facility: Federal University of Bahia
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Eduardo P de Sena, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Bahia
name: Camila S Cosmo, PhD student
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.