Neuromodulation of Executive Function in the ADHD Brain

March 20, 2024 updated by: Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Patricia Cirillo, MD, PhD
  • Phone Number: 6177243217

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02129
        • Recruiting
        • Massachusetts General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 exclusion criteria for healthy controls:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ADHD
Patients with ADHD.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other: Healthy Control
Volunteers without Neuropsychiatric Disorders.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Accuracy and Reaction Time in Attention and Working Memory
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
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
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
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
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
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
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
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
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
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
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Cambridge Gambling Task
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amplitude of Encephalogram (EEG) Event Related Potentials
Time Frame: Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks
Measure of amplitude related to stimulus
Change Before and After Stimulation on Each of the Three Visits, Average 2-6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Joan Camprodon, MD, PhD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P001401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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