Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Device: Transcranial Direct Current Stimulation; Device: Sham

• Registration Number: NCT01968512
• Lead Sponsor: Federal University of Bahia

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).

Study Timeline

• Study First Submitted: 2013-07-29
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-24
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation	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.
TDCS-Sham	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.

Primary Outcome Measures

Name	Time	Method
Quantitative electroencephalography	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.

Secondary Outcome Measures

Name	Time	Method
Functional Brain Network	During the only day of the assessment, we will do it before and after tDCS	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).

Trial Locations

Locations (1)

Federal University of Bahia; 🇧🇷 Salvador, Bahia, Brazil