TDCS for the Treatment of Inattention Symptoms in Adult ADHD Patients (TUNED)

February 18, 2022 updated by: Hospital de Clinicas de Porto Alegre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-007
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Active tDCS
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.
Device: Home-based transcranial direct current stimulation
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.
Other Names:
  • Home-based tDCS
SHAM_COMPARATOR: Sham tDCS
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).
Device: Home-based transcranial direct current stimulation
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.
Other Names:
  • Home-based tDCS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Visit 4 (week 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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)
This is a 75 item self-assessment questionnaire measuring distinct aspects of executive function.
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)
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.
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)
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.
Baseline, Visit 4 (week 4)
Sustained Attention Test
Time Frame: Baseline, Visit 4 (week 4)
In the Sustained Attention Tests subjects are required to respond as quickly as possible to a visual stimulus.
Baseline, Visit 4 (week 4)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory
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)
This is a 21 item rating scale for depression symptoms.
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)
Beck Anxiety Inventory
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)
This is a 21 item rating scale for anxiety symptoms.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luis Augusto Rohde, MD-PhD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-0658

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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