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Completed

NCT Number: NCT04175028

Neuromodulation of Executive Function in the ADHD Brain

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD compared to healthy controls.

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Key information

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

About this study

This study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tDCS) on executive function and inhibitory control in patients with ADHD. Deficits in these cognitive functions are core to ADHD, and cause significant impairment and morbidity. The study will also include a cohort of healthy controls for comparison.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects 18-66 years of age
  • Healthy volunteers or volunteers with a diagnosis of ADHD in adulthood, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) [American Psychiatric Association, 2013] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
  • Patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. Subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. If fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)).
  • English-speaking

Exclusion criteria

  • Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
  • Pregnant or nursing females.
  • Inability to participate in testing procedures
  • Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
  • Additional exclusion criteria for healthy controls:
  • Diagnosis of psychiatric of neurological disorder
  • Ongoing treatment with any psychotropic medications.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Primary outcomes

  1. Change in Accuracy and Reaction Time in Attention and Working Memory

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    N-Back Task

  2. Change in Accuracy and Reaction Time in Attention and Working Memory

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    Flanker Task

  3. Change in Accuracy and Reaction Time in Attention and Working Memory

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    Multi-Source Interference with International Affective Picture System Task

  4. Change in Accuracy and Reaction Time in Inhibition/Decision Making

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    Delayed Discounting

  5. Change in Accuracy and Reaction Time in Inhibition/Decision Making

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    Stop Signal Task

  6. Change in Accuracy and Reaction Time in Inhibition/Decision Making

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    Cambridge Gambling Task

Secondary outcomes

  1. Amplitude of Encephalogram (EEG) Event Related Potentials

    Time frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

    Measure of amplitude related to stimulus

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2019
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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