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

NCT ID: NCT04296604

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

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.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Interventions

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Transcranial Direct Current Stimulation

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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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.

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joan A Camprodon, MD MPH PhD

Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Camprodon, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joan Camprodon, MD, PhD, MPH

Role: CONTACT

6177265348

Patricia Cirillo, MD, PhD

Role: CONTACT

6177243217

Facility Contacts

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Blake Andreou, BS

Role: primary

6177248780

Other Identifiers

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2014P001428

Identifier Type: -

Identifier Source: org_study_id

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