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

Primary Purpose

Traumatic Brain Injury, Major Depressive Disorder, Bipolar Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Transcranial Direct Current Stimulation, Executive Function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Traumatic Brain Injury

Major Depressive Disorder

Bipolar Disorder

Schizophrenia

Attention Deficit Hyperactivity Disorder

Borderline Personality Disorder

Substance Use Disorder

Healthy Controls

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in N-Back Task
Working Memory Task

Secondary Outcome Measures

Change in Flanker Task
Attention and Inhibitory Control Task
Change in Multi-Source Interference with International Affective Picture System Task
Cognitive Control During Emotional Regulation Task
Change in Delayed Discounting Task
Decision-Making Task
Change in Stop Signal Task
Ability to Inhibit a Response Task
Change in Iowa Gambling Task
Risk-Taking Task

Full Information

First Posted
February 28, 2020
Last Updated
April 10, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04296604
Brief Title
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
Official Title
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Attention Deficit Hyperactivity Disorder, Borderline Personality Disorder, Substance Use Disorders
Keywords
Transcranial Direct Current Stimulation, Executive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traumatic Brain Injury
Arm Type
Experimental
Arm Description
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.
Arm Title
Major Depressive Disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Bipolar Disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Schizophrenia
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Deficit Hyperactivity Disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Borderline Personality Disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Substance Use Disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Primary Outcome Measure Information:
Title
Change in N-Back Task
Description
Working Memory Task
Time Frame
Baseline to Post-Treatment, 1 Week
Secondary Outcome Measure Information:
Title
Change in Flanker Task
Description
Attention and Inhibitory Control Task
Time Frame
Baseline to Post-Treatment, 1 Week
Title
Change in Multi-Source Interference with International Affective Picture System Task
Description
Cognitive Control During Emotional Regulation Task
Time Frame
Baseline to Post-Treatment, 1 Week
Title
Change in Delayed Discounting Task
Description
Decision-Making Task
Time Frame
Baseline to Post-Treatment, 1 Week
Title
Change in Stop Signal Task
Description
Ability to Inhibit a Response Task
Time Frame
Baseline to Post-Treatment, 1 Week
Title
Change in Iowa Gambling Task
Description
Risk-Taking Task
Time Frame
Baseline to Post-Treatment, 1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Male and female outpatients 18-65 years of age 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 Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy. Active substance dependence (except for tobacco and cannabis). Pregnant or nursing females. Inability to participate in testing procedures. Additional exclusion criteria for healthy controls: Diagnosis of psychiatric of neurological disorder Ongoing treatment with any psychotropic medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Camprodon, MD, PhD, MPH
Phone
6177265348
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Cirillo, MD, PhD
Phone
6177243217
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Camprodon, MD, PhD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blake Andreou, BS
Phone
617-724-8780
Email
bandreou@mgh.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

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

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