Clinical trial NCT02580890: 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
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-10-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 ...)

Exclusion criteria retrospectively: two fouls in a row dating to stimulation or three fouls in total days.

Primary outcomes:
measure: Change in scores obtained in ASRS scale.
timeFrame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Secondary outcomes:
measure: Change in scores obtained in CGI scale.
timeFrame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
measure: Change in scores obtained in Sheehan disability scale
timeFrame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Professor of Department of Internal Medicine, UFRGS, Brazil.
name: Pedro Schestatsky, MD, PhD
role: STUDY_DIRECTOR
affiliation: MD student from Federal University of Rio Grande do Sul (UFRGS), Brazil.
name: Douglas T Leffa, MD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Department of Psychiatry, UFRGS, Brazil.
name: Luis Augusto Rohde, MD, Phd
role: STUDY_DIRECTOR
affiliation: Associate Professor of Department of Psychiatry, UFRGS, Brazil.
name: Eugenio H Grevet, MD, phD
role: STUDY_DIRECTOR
affiliation: Federal University of Rio Grande do Sul (UFRGS), Brazil
name: Carolina T Cachoeira, MD
role: PRINCIPAL_INVESTIGATOR
References: