Attention Deficit Hyperactivity DisorderTUNEDNCT04003740
TDCS for the Treatment of Inattention Symptoms in Adult ADHD Patients
A study testing Home-based transcranial direct current stimulation in people with Attention Deficit Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study aims at evaluating the efficacy and safety of a home-based tDCS device when compared to a sham stimulation for improving attention in adult ADHD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Home-based transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2019to 18 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing and able to comply with all requirements of the study;
- Subject is able to provide written consent;
- Subject with an estimated Intelligent Quotient (IQ) score of 80 or above on the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III);
- Subject has a diagnosis of ADHD (combined or inattentive subtypes) according to DSM-V;
- Subject scores 21 points or more in the Clinician Administered ADHD self-report scale - part A (inattention symptoms);
- Subject has not received pharmacological treatment for ADHD during the last month;
- If the subject receives pharmacological treatment for other medical conditions, he/she agrees to maintain the same dosage during the study time;
- Subject is classified as European descendent according to morphologic characteristics, color and ancestry.
Who cannot join
- Subject has a previous history of neurosurgery;
- Subject has any ferromagnetic metal in the head;
- Subject has implanted medical devices in the head or neck region;
- Subject has a history of non-controlled epilepsy with seizures in the last year;
- Subject has a current depressive episode with a Beck Depression Inventory > 21 points;
- Subject has a current anxiety episode with a Beck Anxiety Inventory > 21 points;
Show all 13Show fewer
- Subject has a diagnosis of bipolar disorder with maniac or depressive episodes in the last year;
- Subject has a diagnosis of schizophrenia or another psychosis;
- Subject has a diagnosis of autism;
- Subject screened positive for substance use disorder according to The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST);
- Subject has an unstable medical condition with reduction of functional capacity in the next 6 months, like cancer, terminal cardiac disease or terminal pulmonary disease;
- Subject is pregnant or willing to become pregnant in the next 3 months;
- Subject is not able to use a home-based device.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007
About this study
Official title: Transcranial Direct Current Stimulation for the Treatment of Inattention Symptoms in Attention-deficit/Hyperactivity Disorder: a Randomized, Double-blind, Parallel, Controlled Clinical Trial (TUNED Trial)
This study aims at evaluating the efficacy and safety of a home-based tDCS device when compared to a sham stimulation for improving attention in adult ADHD patients.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder characterized by age inappropriate symptoms of inattention, hyperactivity-impulsivity, or both. The diagnosis of ADHD correlates with several negative outcomes during childhood, adolescence and adulthood, creating huge direct and indirect costs for the health system. The treatment of ADHD involves the use of pharmacologic and non-pharmacologic approaches, and stimulant medications are the most commonly used. Although effective, stimulant medication presents several limitations, reducing long-term adherence. Transcranial direct current stimulation (tDCS) is a neuromodulatory tool that has been shown to be effective for the treatment of various neuropsychiatric disorders. Previous pilot studies applying tDCS in ADHD patients showed conflicting results, and were characterized by heterogeneous methodologies. This study aims at evaluating the effectiveness and safety of tDCS for improving attention in adult ADHD patients by using a more strict methodology, based on a pilot study from our group that showed promising results. Besides that, we aim at exploring the mechanisms of action involved in the effect by using genomic and neuroimaging approaches. By using a computational model, we will also measure the association between clinical response and electric field density propagated with the use of tDCS in brain regions involved in attentional tasks. This will be a phase II-III, parallel, with two intervention groups, randomized, placebo-controlled and double blind study. Only patients without current pharmacological treatment for ADHD will be included in order to evaluate the effectiveness of tDCS as an alternative treatment for the disorder. Patients will be randomized to receive tDCS stimulation with either active or sham home-based devices. The stimulation protocol will include one daily stimulation during the first 4 weeks, 2 weekly stimulations for the next 4 weeks, and one weekly stimulation over the last 4 weeks. After the end of the 12 weeks of stimulation, patients will be followed-up during 6 months in order to observe for how long the effects last. The primary outcome will be obtained after the first 4 weeks of stimulation, with the use of a scale that evaluates inattention symptoms. We hypothesize that the active tDCS will reduce inattention symptoms when compared to sham stimulation, and will result in an increased activation of brain regions related to attention performance. In exploratory analyses, by using genomic approaches, we will observe possible associations between treatment response and specific genes, gene pools and polygenic risk scores. In addition, a functional magnetic resonance imaging test will be performed at rest and during both a sustained attention task (Sustained Attention Test), and a working memory task (N-back Test). This will be performed in order to measure the effects of treatment in the activation of brain regions related to attention performance before and after the first 4 weeks of stimulation.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Home-based transcranial direct current stimulation
- 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.
Home-based transcranial direct current stimulationDevice
Also called Home-based tDCS
The stimulation protocol will include one daily stimulation during the first 4 weeks, 2 weekly stimulations for the next 4 weeks, and one weekly stimulation over the last 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | The anode will be placed over the right dorsolateral prefrontal cortex (DLPFC) and the cathode over the left DLPFC. Stimulation will be performed for 30 minutes with a current intensity of 2 mA. A ramp-up time of 20 s for the current to go from zero to 2 mA and a ramp-down time that also takes 20 s for the current to go from 2 mA to zero will be used. Receives: Device: Home-based transcranial direct current stimulation |
| Sham tDCS | Sham comparator | The same montage will be used. Sham stimulation will have the same ramp-up and ramp-down time in three different moments (beginning, middle and at the end of the session). Receives: Device: Home-based transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered ADHD Self-Report Scale - part A (inattention) at Visit 4 (week 4)
The ADHD Self-Report Scale part A consists of 9 items designed to rate ADHD inattention symptoms. Each item is score from 0 to 4, with a total score ranging from 0 to 36 and higher scores indicating greater symptom severity. The scale will be administered by a clinician with the use of adult prompts.
Measured: Baseline, Visit 4 (week 4)
Secondary outcomes (5)
Clinician Administered ADHD Self-Report Scale - total score
The ADHD Self-Report Scale consists of 18 items designed to rate ADHD inattention and hyperactivity/impulsivity symptoms. Each item is score from 0 to 4, with a total score ranging from 0 to 72 and higher scores indicating greater symptom severity. The scale will be administered by a clinician with the use of adult prompts.
Measured: Baseline, Visit 4 (week 4), Visit 5 (week 8), Visit 6 (week 9), Visit 7 (week 10), Visit 8 (week 11), Visit 9 (week 12)
Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
This is a 75 item self-assessment questionnaire measuring distinct aspects of executive function.
Measured: Baseline, Visit 4 (week 4), Visit 5 (week 8), Visit 6 (week 9), Visit 7 (week 10), Visit 8 (week 11), Visit 9 (week 12)
Goal Achievement Scale
This is a questionnaire created in order to identify specific goals that patients would like to achieve with the proposed intervention, and how much they have achieved from each goal.
Measured: Baseline, Visit 4 (week 4), Visit 5 (week 8), Visit 6 (week 9), Visit 7 (week 10), Visit 8 (week 11), Visit 9 (week 12)
N-Back Test
In the N-Back Test subjects are going to be present to a series of letters and required to respond whenever the letter presented is the same as one, two or three before it.
Measured: Baseline, Visit 4 (week 4)
Sustained Attention Test
In the Sustained Attention Tests subjects are required to respond as quickly as possible to a visual stimulus.
Measured: Baseline, Visit 4 (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jul 2019
- Primary completion21 Jul 2021
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Augusto Rohde, MD-PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003740
- Sponsor's protocol ID
- 2018-0658
- Acronym
- TUNED
- Status last verified
- Feb 2022
- First submitted
- 28 Jun 2019
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider M, Ferrazza CP, da Silva Bomber RF, Picon F, Rovaris DL, Sanches PRS, Pereira D, Brunoni AR, Camprodon JA, Caumo W, Bau CHD, Grevet EH, Rohde LA, Leffa DT. Enhancing Goal Achievement in Adults With ADHD: A Participant-Centered Evaluation of Transcranial Direct Current Stimulation From the TUNED Trial. J Atten Disord. 2025 Oct;29(12):1070-1078. doi: 10.1177/10870547251341595. Epub 2025 Jun 17.
PubMed 40524600Leffa DT, Grevet EH, Bau CHD, Schneider M, Ferrazza CP, da Silva RF, Miranda MS, Picon F, Teche SP, Sanches P, Pereira D, Rubia K, Brunoni AR, Camprodon JA, Caumo W, Rohde LA. Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial. JAMA Psychiatry. 2022 Sep 1;79(9):847-856. doi: 10.1001/jamapsychiatry.2022.2055.
PubMed 35921102
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for the Treatment of Inattention Symptoms in Attention-deficit/Hyperactivity Disorder: a Randomized, Double-blind, Parallel, Controlled Clinical Trial (TUNED Trial)
- ClinicalTrials.gov ID
- NCT04003740
- Acronym / sponsor ID
- TUNED / 2018-0658
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 1 Jul 2019 (actual)
- 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.
This study aims at evaluating the efficacy and safety of a home-based tDCS device when compared to a sham stimulation for improving attention in adult ADHD patients.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder characterized by age inappropriate symptoms of inattention, hyperactivity-impulsivity, or both. The diagnosis of ADHD correlates with several negative outcomes during childhood, adolescence and adulthood, creating huge direct and indirect costs for the health system. The treatment of ADHD involves the use of pharmacologic and non-pharmacologic approaches, and stimulant medications are the most commonly used. Although effective, stimulant medication presents several limitations, reducing long-term adherence. Transcranial direct current stimulation (tDCS) is a neuromodulatory tool that has been shown to be effective for the treatment of various neuropsychiatric disorders. Previous pilot studies applying tDCS in ADHD patients showed conflicting results, and were characterized by heterogeneous methodologies. This study aims at evaluating the effectiveness and safety of tDCS for improving attention in adult ADHD patients by using a more strict methodology, based on a pilot study from our group that showed promising results. Besides that, we aim at exploring the mechanisms of action involved in the effect by using genomic and neuroimaging approaches. By using a computational model, we will also measure the association between clinical response and electric field density propagated with the use of tDCS in brain regions involved in attentional tasks. This will be a phase II-III, parallel, with two intervention groups, randomized, placebo-controlled and double blind study. Only patients without current pharmacological treatment for ADHD will be included in order to evaluate the effectiveness of tDCS as an alternative treatment for the disorder. Patients will be randomized to receive tDCS stimulation with either active or sham home-based devices. The stimulation protocol will include one daily stimulation during the first 4 weeks, 2 weekly stimulations for the next 4 weeks, and one weekly stimulation over the last 4 weeks. After the end of the 12 weeks of stimulation, patients will be followed-up during 6 months in order to observe for how long the effects last. The primary outcome will be obtained after the first 4 weeks of stimulation, with the use of a scale that evaluates inattention symptoms. We hypothesize that the active tDCS will reduce inattention symptoms when compared to sham stimulation, and will result in an increased activation of brain regions related to attention performance. In exploratory analyses, by using genomic approaches, we will observe possible associations between treatment response and specific genes, gene pools and polygenic risk scores. In addition, a functional magnetic resonance imaging test will be performed at rest and during both a sustained attention task (Sustained Attention Test), and a working memory task (N-back Test). This will be performed in order to measure the effects of treatment in the activation of brain regions related to attention performance before and after the first 4 weeks of stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Home-based transcranial direct current stimulationThe anode will be placed over the right dorsolateral prefrontal cortex (DLPFC) and the cathode over the left DLPFC. Stimulation will be performed for 30 minutes with a current intensity of 2 mA. A ramp-up time of 20 s for the current to go from zero to 2 mA and a ramp-down time that also takes 20 s for the current to go from 2 mA to zero will be used. |
| Sham tDCS | Sham comparator | Device: Home-based transcranial direct current stimulationThe same montage will be used. Sham stimulation will have the same ramp-up and ramp-down time in three different moments (beginning, middle and at the end of the session). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is willing and able to comply with all requirements of the study;
- Subject is able to provide written consent;
- Subject with an estimated Intelligent Quotient (IQ) score of 80 or above on the Wechsler Adult Intelligence Scale, Third Edition (WAIS-III);
- Subject has a diagnosis of ADHD (combined or inattentive subtypes) according to DSM-V;
- Subject scores 21 points or more in the Clinician Administered ADHD self-report scale - part A (inattention symptoms);
Key exclusion criteria (13 listed)
- Subject has a previous history of neurosurgery;
- Subject has any ferromagnetic metal in the head;
- Subject has implanted medical devices in the head or neck region;
- Subject has a history of non-controlled epilepsy with seizures in the last year;
- Subject has a current depressive episode with a Beck Depression Inventory > 21 points;
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 |
|---|---|---|
| Home-based transcranial direct current stimulationAlso: Home-based tDCSThe stimulation protocol will include one daily stimulation during the first 4 weeks, 2 weekly stimulations for the next 4 weeks, and one weekly stimulation over the last 4 weeks. | Device | Active tDCS, Sham tDCS |
Primary outcome
Clinician Administered ADHD Self-Report Scale - part A (inattention) at Visit 4 (week 4)
Time frame: Baseline, Visit 4 (week 4)
The ADHD Self-Report Scale part A consists of 9 items designed to rate ADHD inattention symptoms. Each item is score from 0 to 4, with a total score ranging from 0 to 36 and higher scores indicating greater symptom severity. The scale will be administered by a clinician with the use of adult prompts.
5 secondary outcomes
Clinician Administered ADHD Self-Report Scale - total score
Time frame: Baseline, Visit 4 (week 4), Visit 5 (week 8), Visit 6 (week 9), Visit 7 (week 10), Visit 8 (week 11), Visit 9 (week 12)
Behavior Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)
Time frame: Baseline, Visit 4 (week 4), Visit 5 (week 8), Visit 6 (week 9), Visit 7 (week 10), Visit 8 (week 11), Visit 9 (week 12)
Goal Achievement Scale
Time frame: Baseline, Visit 4 (week 4), Visit 5 (week 8), Visit 6 (week 9), Visit 7 (week 10), Visit 8 (week 11), Visit 9 (week 12)
N-Back Test
Time frame: Baseline, Visit 4 (week 4)
Sustained Attention Test
Time frame: Baseline, Visit 4 (week 4)
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 21 Feb 2022.
- Derived from this study: PubMed 40524600Schneider M, Ferrazza CP, da Silva Bomber RF, Picon F, Rovaris DL, Sanches PRS, Pereira D, Brunoni AR, Camprodon JA, Caumo W, Bau CHD, Grevet EH, Rohde LA, Leffa DT. Enhancing Goal Achievement in Adults With ADHD: A Participant-Centered Evaluation of Transcranial Direct Current Stimulation From the TUNED Trial. J Atten Disord. 2025 Oct;29(12):1070-1078. doi: 10.1177/10870547251341595. Epub 2025 Jun 17.
- Derived from this study: PubMed 35921102Leffa DT, Grevet EH, Bau CHD, Schneider M, Ferrazza CP, da Silva RF, Miranda MS, Picon F, Teche SP, Sanches P, Pereira D, Rubia K, Brunoni AR, Camprodon JA, Caumo W, Rohde LA. Transcranial Direct Current Stimulation vs Sham for the Treatment of Inattention in Adults With Attention-Deficit/Hyperactivity Disorder: The TUNED Randomized Clinical Trial. JAMA Psychiatry. 2022 Sep 1;79(9):847-856. doi: 10.1001/jamapsychiatry.2022.2055.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Luis Augusto Rohde, MD-PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based transcranial direct current stimulation 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 8 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 21 Feb 2022. 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?
Clinician Administered ADHD Self-Report Scale - part A (inattention) at Visit 4 (week 4) (time frame: Baseline, Visit 4 (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003740, which also lists 2 linked publications.
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 21 Feb 2022.