Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

— NAADHD  

Official title:

Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder: Contribution of the Transcranial Direct Current Stimulation in Control Inhibitory.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968512
• Other study ID #: 285.841
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: April 30, 2014
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• Transcranial Direct Current Stimulation
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.
• Sham
Same character of Transcranial Direct Current Stimulation but without current

Locations

Country	Name	City	State
Brazil	Federal University of Bahia	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Go/No Go test	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).	During the only day of the assessment, we will do it before and after tDCS	No
Primary	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.	During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS	No
Secondary	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).	During the only day of the assessment, we will do it before and after tDCS	No