Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

NCT ID: NCT01968512

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-04-30

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).

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

Same character of Transcranial Direct Current Stimulation but without current

Interventions

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.

Intervention Type: DEVICE

Sham

Same character of Transcranial Direct Current Stimulation but without current

Intervention Type: DEVICE

Other Intervention Names

tDCS

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Bahia

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Pondé de Sena

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduardo P de Sena, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Camila S Cosmo, PhD student

Role: STUDY_DIRECTOR

Federal University of Bahia

Locations

Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 26300790 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26267861 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25986784 (View on PubMed)

Other Identifiers

285.841

Identifier Type: -

Identifier Source: org_study_id