Neuromodulation of Executive Function in the ADHD Brain

NCT04175028 | Completed DMC FDA Device

• 1 other identifier: 2014P001401
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Executive Function

Outcome Measures

Primary Outcomes (6)

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

  N-Back Task

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

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

  Flanker Task

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

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

  Multi-Source Interference with International Affective Picture System Task

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

• Change in Accuracy and Reaction Time in Inhibition/Decision Making

  Delayed Discounting

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

• Change in Accuracy and Reaction Time in Inhibition/Decision Making

  Stop Signal Task

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

• Change in Accuracy and Reaction Time in Inhibition/Decision Making

  Cambridge Gambling Task

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

Secondary Outcomes (1)

• Amplitude of Encephalogram (EEG) Event Related Potentials

  Change Before and After Stimulation on Each of the Three Visits, Average 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 - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18-66 years of age
• 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.
• 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)).
• English-speaking

You may not qualify if:

• Current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders.
• Pregnant or nursing females.
• Inability to participate in testing procedures
• Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.
• Diagnosis of psychiatric of neurological disorder
• Ongoing treatment with any psychotropic medications.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

• 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.

  PMID: 33549516 DERIVED

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: September 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)