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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: tDCS active
* Device: tDCS sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS active<br>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<br>* 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.<br>|
| Sham Comparator: tDCS sham<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores obtained in CGI scale. | 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 |  | Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment). |