Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations

March 20, 2024 updated by: Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain. The investigators will select 8 relevant diagnostic categories: traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorder. The study will also include a cohort of healthy controls for comparison.

Study Type

Interventional

Enrollment (Estimated)

600

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: Joan Camprodon, MD, PhD, MPH
  • Phone Number: 6177265348

Study Contact Backup

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

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  1. Male and female outpatients 18-65 years of age
  2. A diagnosis of traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorders meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

Exclusion Criteria

  1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.
  2. Active substance dependence (except for tobacco and cannabis).
  3. Pregnant or nursing females.
  4. Inability to participate in testing procedures.

  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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Traumatic Brain Injury
This group consists of individuals diagnosed with traumatic brain injury. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Experimental: Major Depressive Disorder
This group consists of individuals diagnosed with major depressive disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Experimental: Bipolar Disorder
This group consists of individuals diagnosed with bipolar disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Experimental: Schizophrenia
This group consists of individuals diagnosed with schizophrenia. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Experimental: Attention Deficit Hyperactivity Disorder
This group consists of individuals diagnosed with attention deficit hyperactivity disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Experimental: Borderline Personality Disorder
This group consists of individuals diagnosed with borderline personality disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Experimental: Substance Use Disorder
This group consists of individuals diagnosed with substance use disorder. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS
Active Comparator: Healthy Controls
This group consists of individuals diagnosed with healthy controls. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Device: Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in N-Back Task
Time Frame: Baseline to Post-Treatment, 1 Week
Working Memory Task
Baseline to Post-Treatment, 1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Flanker Task
Time Frame: Baseline to Post-Treatment, 1 Week
Attention and Inhibitory Control Task
Baseline to Post-Treatment, 1 Week
Change in Multi-Source Interference with International Affective Picture System Task
Time Frame: Baseline to Post-Treatment, 1 Week
Cognitive Control During Emotional Regulation Task
Baseline to Post-Treatment, 1 Week
Change in Delayed Discounting Task
Time Frame: Baseline to Post-Treatment, 1 Week
Decision-Making Task
Baseline to Post-Treatment, 1 Week
Change in Stop Signal Task
Time Frame: Baseline to Post-Treatment, 1 Week
Ability to Inhibit a Response Task
Baseline to Post-Treatment, 1 Week
Change in Iowa Gambling Task
Time Frame: Baseline to Post-Treatment, 1 Week
Risk-Taking Task
Baseline to Post-Treatment, 1 Week

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

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

February 28, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 5, 2020

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

  • 2014P001428

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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