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Neuromodulation of Executive Function in the ADHD Brain

Neuromodulation of Executive Function in the ADHD Brain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04175028
Enrollment
83
Registered
2019-11-22
Start date
2014-09-30
Completion date
2018-06-01
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

Executive Function

Brief summary

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.

Detailed description

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.

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 66 Years
Healthy volunteers
Yes

Inclusion criteria

1. Male and female subjects 18-66 years of age 2. 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. 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. English-speaking

Exclusion criteria

1. Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders. 2. Pregnant or nursing females. 3. Inability to participate in testing procedures 4. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy. 5. Additional

Design outcomes

Primary

MeasureTime frameDescription
Change in Accuracy and Reaction Time in Attention and Working MemoryChange Before and After Stimulation on Each of the Three Visits, Average 2-6 WeeksN-Back Task
Change in Accuracy and Reaction Time in Inhibition/Decision MakingChange Before and After Stimulation on Each of the Three Visits, Average 2-6 WeeksDelayed Discounting

Secondary

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

Countries

United States

Outcome results

None listed

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