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Clinical Trials/NCT02580890
NCT02580890
Completed
Not Applicable

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

Hospital de Clinicas de Porto Alegre1 site in 1 country16 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
16
Locations
1
Primary Endpoint
Change in scores obtained in ASRS scale.
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • dependence of substances
  • Mental retardation or dementia
  • Epilepsy or anticonvulsant use
  • Clinically significant medical condition

Outcomes

Primary Outcomes

Change in scores obtained in ASRS scale.

Time Frame: 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 Outcomes

  • Change in scores obtained in CGI scale.(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).)

Study Sites (1)

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