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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04296604
Collaborator
(none)
600
Enrollment
1
Location
8
Arms
96
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
Actual Study Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in N-Back Task [Baseline to Post-Treatment, 1 Week]

      Working Memory Task

    Secondary Outcome Measures

    1. Change in Flanker Task [Baseline to Post-Treatment, 1 Week]

      Attention and Inhibitory Control Task

    2. Change in Multi-Source Interference with International Affective Picture System Task [Baseline to Post-Treatment, 1 Week]

      Cognitive Control During Emotional Regulation Task

    3. Change in Delayed Discounting Task [Baseline to Post-Treatment, 1 Week]

      Decision-Making Task

    4. Change in Stop Signal Task [Baseline to Post-Treatment, 1 Week]

      Ability to Inhibit a Response Task

    5. Change in Iowa Gambling Task [Baseline to Post-Treatment, 1 Week]

      Risk-Taking Task

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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:

    6. Diagnosis of psychiatric of neurological disorder

    7. Ongoing treatment with any psychotropic medications.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02129

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joan A Camprodon, MD MPH PhD, Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04296604
    Other Study ID Numbers:
    • 2014P001428
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Joan A Camprodon, MD MPH PhD, Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation, Massachusetts General Hospital
    Transcranial Direct Current Stimulation
    Executive Function
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Disease
    Substance-Related Disorders
    Schizophrenia
    Depressive Disorder
    Depressive Disorder, Major
    Bipolar Disorder
    Attention Deficit Disorder with Hyperactivity
    Personality Disorders
    Borderline Personality Disorder

    Study Results

    No Results Posted as of Jul 22, 2022