Traumatic Brain InjuryNCT04296604
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
A study testing Transcranial Direct Current Stimulation in people with Traumatic Brain Injury and Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joan Camprodon, MD, PhD, MPH contact
Patricia Cirillo, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02129
Blake Andreou, BS, 6177248780, bandreou@mgh.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Attention Deficit Hyperactivity Disorder, Borderline Personality Disorder
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current Stimulation, Executive Function
- Medical subject headings
- Brain Injuries, Traumatic, Depressive Disorder, Major, Bipolar Disorder, Schizophrenia, Attention Deficit Disorder with Hyperactivity, Borderline Personality Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Major Depressive Disorder | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Bipolar Disorder | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Schizophrenia | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Attention Deficit Hyperactivity Disorder | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Borderline Personality Disorder | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Substance Use Disorder | Experimental | 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. Receives: Device: Transcranial Direct Current Stimulation |
| Healthy Controls | Active comparator | 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in N-Back Task
Working Memory Task
Measured: Baseline to Post-Treatment, 1 Week
Secondary outcomes (5)
Change in Flanker Task
Attention and Inhibitory Control Task
Measured: Baseline to Post-Treatment, 1 Week
Change in Multi-Source Interference with International Affective Picture System Task
Cognitive Control During Emotional Regulation Task
Measured: Baseline to Post-Treatment, 1 Week
Change in Delayed Discounting Task
Decision-Making Task
Measured: Baseline to Post-Treatment, 1 Week
Change in Stop Signal Task
Ability to Inhibit a Response Task
Measured: Baseline to Post-Treatment, 1 Week
Change in Iowa Gambling Task
Risk-Taking Task
Measured: Baseline to Post-Treatment, 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startSep 2014
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan A Camprodon, MD MPH PhD, Massachusetts General Hospital
- Investigators
- Joan Camprodon, MD, PhD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296604
- Sponsor's protocol ID
- 2014P001428
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2020
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
- ClinicalTrials.gov ID
- NCT04296604
- Acronym / sponsor ID
- 2014P001428
- Conditions
- Traumatic Brain Injury, Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Attention Deficit Hyperactivity Disorder, Borderline Personality Disorder
- Keywords
- Transcranial Direct Current Stimulation, Executive Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Major Depressive Disorder | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Bipolar Disorder | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Schizophrenia | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Attention Deficit Hyperactivity Disorder | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Borderline Personality Disorder | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Substance Use Disorder | Experimental | Device: Transcranial Direct Current StimulationThis 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. |
| Healthy Controls | Active comparator | Device: Transcranial Direct Current StimulationThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSIn tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes. | Device | Attention Deficit Hyperactivity Disorder, Bipolar Disorder, Borderline Personality Disorder, Healthy Controls, Major Depressive Disorder, Schizophrenia, Substance Use Disorder, Traumatic Brain Injury |
Primary outcome
Change in N-Back Task
Time frame: Baseline to Post-Treatment, 1 Week
Working Memory Task
5 secondary outcomes
Change in Flanker Task
Time frame: Baseline to Post-Treatment, 1 Week
Change in Multi-Source Interference with International Affective Picture System Task
Time frame: Baseline to Post-Treatment, 1 Week
Change in Delayed Discounting Task
Time frame: Baseline to Post-Treatment, 1 Week
Change in Stop Signal Task
Time frame: Baseline to Post-Treatment, 1 Week
Change in Iowa Gambling Task
Time frame: Baseline to Post-Treatment, 1 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joan Camprodon, MD, PhD, MPH contact
Patricia Cirillo, MD, PhD contact
Joan Camprodon, MD, PhD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Traumatic Brain Injury and Major Depressive Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan Camprodon, MD, PhD, MPH (6177265348), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in N-Back Task (time frame: Baseline to Post-Treatment, 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.