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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04175041
Enrollment
104
Registered
2019-11-22
Start date
2019-07-09
Completion date
2026-05-31
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Transcranial Direct Current Stimulation

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.

Detailed description

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.

Interventions

DEVICETranscranial Direct Current Stimulation

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

(Patients) 1. Male and female outpatients 18-55 years of age 2. A diagnosis of ADD/ADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. 3. 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)). 4. If on non-stimulant medications, dose must have been stable for at least 4 weeks.

Exclusion criteria

(Patients) 1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy. 2. Active substance dependence (except for tobacco). 3. Pregnant or nursing females. 4. Inability to participate in testing procedures. Inclusion Criteria (Healthy Control) 1\. Male and female outpatients 18-55 years of age

Design outcomes

Primary

MeasureTime frameDescription
Change in Accuracy and Reaction Time in Attention and Working MemoryChange Before and After Stimulation on Each of the Four Visits, Average of 2-6 WeeksMeasured using Eriksen Flanker Task (EFT)

Secondary

MeasureTime frameDescription
Amplitude of Electroencephalogram (EEG) Event Related PotentialsChange Before and After Stimulation on Each of the Four Visits, Average of 2-6 WeeksMeasure of amplitude related to stimulus

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026