Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

NCT01968512 | Completed

• 1 other identifier: 285.841
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Functional Brain Network

  During the only day of the assessment, we will do it before and after tDCS

Other Outcomes (1)

• Go/No Go test

  During the only day of the assessment, we will do it before and after tDCS

Study Arms (2)

Transcranial Direct Current Stimulation

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation

TDCS-Sham

SHAM COMPARATOR

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.

Device: Sham

Interventions

Transcranial Direct Current Stimulation 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.

Also known as: tDCS

Transcranial Direct Current Stimulation

Sham DEVICE

Same character of Transcranial Direct Current Stimulation but without current

TDCS-Sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Federal University of Bahia

Salvador, Estado de Bahia, 40000-000, Brazil

Location

Related Publications (3)

• 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.

  PMID: 26300790 DERIVED

• 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.

  PMID: 26267861 DERIVED

• 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.

  PMID: 25986784 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Eduardo P de Sena, PhD

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• Camila S Cosmo, PhD student

  Federal University of Bahia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: October 24, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

BR (1)