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

NCT04175041 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2018P002889
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Accuracy and Reaction Time in Attention and Working Memory

  Measured using Eriksen Flanker Task (EFT)

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

Secondary Outcomes (1)

• Amplitude of Electroencephalogram (EEG) Event Related Potentials

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

Study Arms (2)

ADHD

OTHER

Patients with ADHD.

Device: Transcranial Direct Current Stimulation

Healthy Control

OTHER

Volunteers without Neuropsychiatric Disorders.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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

ADHD; Healthy Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Male and female outpatients 18-55 years of age
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Joan Camprodon, MD, PhD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 22, 2019
• Study Start: July 9, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)