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

Mass General Brigham

Status: Enrolling

Conditions: Major Depressive Disorder; Traumatic Brain Injury; Attention Deficit Hyperactivity Disorder; Borderline Personality Disorder; Schizophrenia; Bipolar Disorder; Substance Use Disorders

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04296604

2014P001428

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 8 patient groups

Traumatic Brain Injury

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Major Depressive Disorder

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Bipolar Disorder

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Schizophrenia

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Attention Deficit Hyperactivity Disorder

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Borderline Personality Disorder

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Substance Use Disorder

Experimental group

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Healthy Controls

Active Comparator group

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.

Treatment:

Device: Transcranial Direct Current Stimulation