Attention Deficit Hyperactivity Disorder
Conditions
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
Interventions
DEVICEtDCS 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.
DEVICEtDCS 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.
Sponsors
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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 ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores obtained in ASRS scale. | Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment). | This scale is used to access symptoms improvement in ADHD patients, is a self repor scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores obtained in CGI scale. | Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment). | This scale is used to access clinical improvement in ADHD patients, |
| 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). | — |
Countries
Brazil
Outcome results
None listed