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Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder (NAADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder (ADHD);, Transcranial Direct Current Stimulation (tDCS);, Control Inhibitory;, Quantitative electroencephalography;, Functional Brain Network;, Go/No Go test.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Bahia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Direct Current Stimulation

TDCS-Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 29, 2013
Last Updated
April 30, 2014
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01968512
Brief Title
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder
Acronym
NAADHD
Official Title
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder: Contribution of the Transcranial Direct Current Stimulation in Control Inhibitory.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
TDCS-Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Same character of Transcranial Direct Current Stimulation but without current
Primary Outcome Measure Information:
Title
Quantitative electroencephalography
Description
Quantitative electroencephalography to assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs.
Time Frame
During the only day of the assessment, we will do it before (during 8 minutes) and after (during 8 minutes more) tDCS
Secondary Outcome Measure Information:
Title
Functional Brain Network
Description
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).
Time Frame
During the only day of the assessment, we will do it before and after tDCS
Other Pre-specified Outcome Measures:
Title
Go/No Go test
Description
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).
Time Frame
During the only day of the assessment, we will do it before and after tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo P de Sena, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Camila S Cosmo, PhD student
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40000-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26300790
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.
Results Reference
derived
PubMed Identifier
26267861
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.
Results Reference
derived
PubMed Identifier
25986784
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.
Results Reference
derived

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Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

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