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Active, Not Recruiting

NCT Number: NCT04175041

A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC

To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

About this study

To determine the cognitive and neurophysiological dose-response relationships of anodal tDCS to the left DLPFC as a function of absolute current intensity, individualized E-field intensity, and stimulation duration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(Patients)

  • Male and female outpatients 18-55 years of age
  • A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
  • 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)).
  • If on non-stimulant medications, dose must have been stable for at least 4 weeks.

Exclusion criteria

(Patients)

  • Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
  • Active substance dependence (except for tobacco).
  • Pregnant or nursing females.
  • Inability to participate in testing procedures.

Inclusion criteria

(Healthy Control)

  • Male and female outpatients 18-55 years of age

Exclusion criteria

(Healthy Control)

  • Diagnosis of psychiatric of neurological disorder
  • Ongoing treatment with any psychotropic medications.
  • Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
  • Active substance dependence (except for tobacco).
  • Pregnant or nursing females.
  • Inability to participate in testing procedures.

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 Four Visits, Average of 2-6 Weeks

    Measured using Eriksen Flanker Task (EFT)

Secondary outcomes

  1. Amplitude of Electroencephalogram (EEG) Event Related Potentials

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

    Measure of amplitude related to stimulus

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
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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