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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

tDCS active

tDCS sham

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS active

tDCS sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in scores obtained in ASRS scale.

This scale is used to access symptoms improvement in ADHD patients, is a self repor scale.

Secondary Outcome Measures

Change in scores obtained in CGI scale.

This scale is used to access clinical improvement in ADHD patients,

Change in scores obtained in Sheehan disability scale

Full Information

NCT ID

NCT02580890

First Posted

October 19, 2015

Last Updated

February 24, 2016

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02580890

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS active

Arm Type

Experimental

Arm Description

Arm Title

tDCS sham

Arm Type

Sham Comparator

Arm Description

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

Intervention Name(s)

tDCS active

Intervention Description

Intervention Type

Device

Intervention Name(s)

tDCS sham

Intervention Description

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 Outcome Measure Information:

Title

Change in scores obtained in ASRS scale.

Description

This scale is used to access symptoms improvement in ADHD patients, is a self repor scale.

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in scores obtained in CGI scale.

Description

This scale is used to access clinical improvement in ADHD patients,

Time Frame

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

Title

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials: