Recruiting

tDCS

Sponsor:

Massachusetts General Hospital

Code:

NCT04296604

Conditions

Traumatic Brain Injury

Major Depressive Disorder

Bipolar Disorder

Schizophrenia

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcranial Direct Current Stimulation

Study Details

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.

Conditions

Traumatic Brain Injury

Major Depressive Disorder

Bipolar Disorder

Schizophrenia

Attention Deficit Hyperactivity Disorder

Study ID

NCT04296604

Start date

Sep, 2014

Status verified date

Sep, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

Transcranial Direct Current Stimulation

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

Primary outcome measure

  • Change in N-Back Task [ Time Frame: Baseline to Post-Treatment, 1 Week ]

Central Contacts and Locations

Central contacts

Joan Camprodon, MD, PhD, MPH

6177265348

Patricia Cirillo, MD, PhD

6177243217

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Blake Andreou, BS

6177248780bandreou@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • Transcranial Direct Current Stimulation
  • Executive Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-10.