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

NCT ID: NCT02580890

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

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

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

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

tDCS active

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

tDCS sham

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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 ...)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Schestatsky, MD, PhD

Role: STUDY_DIRECTOR

Professor of Department of Internal Medicine, UFRGS, Brazil.

Douglas T Leffa, MD student

Role: PRINCIPAL_INVESTIGATOR

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

Luis Augusto Rohde, MD, Phd

Role: STUDY_DIRECTOR

Professor of Department of Psychiatry, UFRGS, Brazil.

Eugenio H Grevet, MD, phD

Role: STUDY_DIRECTOR

Associate Professor of Department of Psychiatry, UFRGS, Brazil.

Carolina T Cachoeira, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

13-0498

Identifier Type: -

Identifier Source: org_study_id