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Completed

NCT Number: NCT02580890

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

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

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 91910-630, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Depressive episode with BDI greater than 9
  • Anxiety Disorder with greater than 15 BAI
  • Bipolar Disorder with depressive symptoms, manic or hypomanic in the last 6 months
  • Schizophrenia and other psychotic disorders
  • Autism
  • dependence of substances
  • 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.

Treatment and study plan

tDCS active

Device

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.

tDCS sham

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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,

  2. 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).

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

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

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2015
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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