Neuromodulation of Executive Function in the ADHD Brain

NCT ID: NCT04175028

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADHD

Patients with ADHD.

Group Type OTHER

Transcranial Direct Current Stimulation

Intervention Type DEVICE

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

Healthy Control

Volunteers without Neuropsychiatric Disorders.

Group Type OTHER

Transcranial Direct Current Stimulation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial Direct Current Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

1. Diagnosis of psychiatric of neurological disorder
2. Ongoing treatment with any psychotropic medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joan A Camprodon, MD MPH PhD

Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joan Camprodon, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10.1016/j.bpsc.2020.11.006. Epub 2020 Nov 25.

Reference Type DERIVED
PMID: 33549516 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014P001401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Methylphenidate on Connectivity
NCT01764672 WITHDRAWN PHASE4