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| Name | Class |
|---|---|
| Federal University of Rio Grande do Sul | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Medication change in the last month
The following comorbidities:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 91910-630 | Brazil |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
| Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment). |