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

NCT02580890 | Completed

• 1 other identifier: 13-0498
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change in scores obtained in ASRS scale.

  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 Outcomes (2)

• Change in scores obtained in CGI scale.

  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

  Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).

Study Arms (2)

tDCS active

EXPERIMENTAL

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

tDCS sham

SHAM COMPARATOR

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

Interventions

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 active

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.

tDCS sham

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 ...)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

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

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Pedro Schestatsky, MD, PhD

  Professor of Department of Internal Medicine, UFRGS, Brazil.

  STUDY DIRECTOR

• Douglas T Leffa, MD student

  MD student from Federal University of Rio Grande do Sul (UFRGS), Brazil.

  PRINCIPAL INVESTIGATOR

• 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.

  STUDY DIRECTOR

• Carolina T Cachoeira, MD

  Federal University of Rio Grande do Sul (UFRGS), Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

BR (1)