Attention Deficit Hyperactivity DisorderNCT02580890
Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing tDCS active in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- tDCS active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 91910-630
About this study
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
Read more
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
Read the 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
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- tDCS active, tDCS sham
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS activeDevice
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.
tDCS shamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: tDCS active |
| 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. Receives: Device: tDCS sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores obtained in ASRS scale.
This scale is used to access symptoms improvement in ADHD patients, is a self repor scale.
Measured: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Secondary outcomes (2)
Change in scores obtained in CGI scale.
This scale is used to access clinical improvement in ADHD patients,
Measured: 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
Measured: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Pedro Schestatsky, MD, PhD, Study director, Professor of Department of Internal Medicine, UFRGS, Brazil.Douglas T Leffa, MD student, Principal investigator, MD student from Federal University of Rio Grande do Sul (UFRGS), Brazil.Luis Augusto Rohde, MD, Phd, Study director, Professor of Department of Psychiatry, UFRGS, Brazil.Eugenio H Grevet, MD, phD, Study director, Associate Professor of Department of Psychiatry, UFRGS, Brazil.Carolina T Cachoeira, MD, Principal investigator, Federal University of Rio Grande do Sul (UFRGS), Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580890
- Sponsor's protocol ID
- 13-0498
- Status last verified
- Feb 2016
- First submitted
- 19 Oct 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02580890
- Acronym / sponsor ID
- 13-0498
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS active | Experimental | Device: tDCS activeStimulation 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 | Device: tDCS shamFor 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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 ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS activeStimulation 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. | Device | tDCS active |
| tDCS shamFor 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 |
Primary outcome
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.
2 secondary outcomes
Change in scores obtained in CGI scale.
Time frame: 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
Time frame: Autcome measure assesments: day 1 (pre-intervention), day 5 (post-intervention), 1 and 4 weeks later (accompaniment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Schestatsky, MD, PhD study director
Professor of Department of Internal Medicine, UFRGS, Brazil.
Douglas T Leffa, MD student principal investigator
MD student from Federal University of Rio Grande do Sul (UFRGS), Brazil.
Luis Augusto Rohde, MD, Phd study director
Professor of Department of Psychiatry, UFRGS, Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS active in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.