NCT04003740

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

June 28, 2019

Last Update Submit

February 18, 2022

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Visit 4 (week 4)

Secondary Outcomes (5)

  • Clinician Administered ADHD Self-Report Scale - total score

    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)

    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

    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

    Baseline, Visit 4 (week 4)

  • Sustained Attention Test

    Baseline, Visit 4 (week 4)

Other Outcomes (2)

  • Beck Depression Inventory

    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

    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)

Study Arms (2)

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.

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).

Device: Home-based transcranial direct current stimulation

Interventions

Home-based transcranial direct current stimulationDEVICE

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.

Also known as: Home-based tDCS
Active tDCSSham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 40524600DERIVED

  • Leffa 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.

    PMID: 35921102DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Luis Augusto Rohde, MD-PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 1, 2019

Study Start

July 1, 2019

Primary Completion

July 21, 2021

Study Completion

February 18, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)