Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)

February 24, 2016 updated by: Hospital de Clinicas de Porto Alegre

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).

Randomized, double-blind Controlled Clinical Trial

Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria and who agree to participate in the study Will recruit from advertisements and clinical referrals to a PRODAH

Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is applied for 20 min

Sham tDCS Same assembly is used Current is applied for 30 sec

Both groups 5 stimulation sessions on consecutive days

Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, double-blind Controlled Clinical Trial

Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria and who agree to participate in the study Will recruit from advertisements and clinical referrals to a PRODAH

Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is applied for 20 min

Sham tDCS Same assembly is used Current is applied for 30 sec

Both groups 5 stimulation sessions on consecutive days

Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 91910-630
        • Hospital De Clinicas De Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 to 45 years
  • Established diagnosis of ADHD according to DSM V through clinical interview and diagnostic criteria applied by trained physicians.
  • ASRS greater than 21 in Part A or B
  • Consent form signed
  • Ability to read and interpret the self-applicable scales

Exclusion Criteria:

  • Medication change in the last month

  • The following comorbidities:

    1. Depressive episode with BDI greater than 9
    2. Anxiety Disorder with greater than 15 BAI
    3. Bipolar Disorder with depressive symptoms, manic or hypomanic in the last 6 months
    4. Schizophrenia and other psychotic disorders
    5. Autism
    6. dependence of substances
    7. Mental retardation or dementia
  • Epilepsy or anticonvulsant use
  • Clinically significant medical condition
  • Contraindications for tDCS (metallic implants, cranioencefálica important anatomical change ...)

Exclusion criteria retrospectively: two fouls in a row dating to stimulation or three fouls in total days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS active
Stimulation will be performed with the anode placed over the right DLPFC, and the cathode placed on the left DLPFC. The applied electric current will be 2mA and is going to be applied for 20 minutes. The electrodes have a size of 35cm ² each and will be covered by sponges soaked with saline. The stimulator to be used will be the "Chattanooga Ionto ISO 13485". Stimulation will be performed for 5 days, one time per day.
Device: tDCS active
Stimulation will be performed with the anode placed over the right DLPFC, and the cathode placed on the left DLPFC. The applied electric current will be 2mA and is going to be applied for 20 minutes. The electrodes have a size of 35cm ² each and will be covered by sponges soaked with saline.
Sham Comparator: tDCS sham
For the sham tDCS, the same setting will be used. However, the current is going to be applied for only 30 seconds, not being able to induce effects on neuronal excitability.
Device: tDCS sham
For the sham tDCS, the same setting will be used. However, the current is going to be applied for only 30 seconds, not being able to induce effects on neuronal excitability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scores obtained in ASRS scale.
Time Frame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
This scale is used to access symptoms improvement in ADHD patients, is a self repor scale.
Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scores obtained in CGI scale.
Time Frame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
This scale is used to access clinical improvement in ADHD patients,
Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Change in scores obtained in Sheehan disability scale
Time Frame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Director: Pedro Schestatsky, MD, PhD, Professor of Department of Internal Medicine, UFRGS, Brazil.
  • Principal Investigator: Douglas T Leffa, MD student, MD student from Federal University of Rio Grande do Sul (UFRGS), Brazil.
  • Study Director: Luis Augusto Rohde, MD, Phd, Professor of Department of Psychiatry, UFRGS, Brazil.
  • Study Director: Eugenio H Grevet, MD, phD, Associate Professor of Department of Psychiatry, UFRGS, Brazil.
  • Principal Investigator: Carolina T Cachoeira, MD, Federal University of Rio Grande do Sul (UFRGS), Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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