Traumatic Brain InjuryPhase 1NCT02169310
Neural Basis of Decision-Making Deficits in Traumatic Brain Injury
A Phase 1 study testing tDCS and [11C] Raclopride in people with Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: People with a traumatic brain injury (TBI) can have trouble making the best possible decisions. Researchers want to learn more about the parts of the brain that control decision making. They also want to know how these are different between people. This may help predict how people make decisions after TBI. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- tDCS and [11C] Raclopride
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2014to 13 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 60
- Able to give consent
- Must be able to follow instructions and perform required tasks
- Absence of clinically significant abnormalities during neurological examination
- Age 18 to 60
- Able to give consent
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- Must be able to follow instructions and perform required tasks.
- History of having a sustained, traumatically induced (e.g., collision between the head and an object, or sudden acceleration/deceleration of the brain without direct
- external trauma to the head) physiological disruption of brain function, as manifested by at least one of the following (based on the American Congress of Rehabilitation Medicine Criteria):
- Any period of loss of consciousness
- Any loss of memory for events immediately before or after the accident
- Focal neurological deficit(s) that may or may not be transient
- Any alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused)
- Presentation to a healthcare provider within 24 hours of the injury event
- History of self-reported complaints or clinical findings related to planning or decision-making deficits
Who cannot join
- Pre-existing and disabling major psychiatric (e.g., schizophrenia, bipolar disorder or post-traumatic stress disorder) or neurological disease (e.g., stroke, dementia, epilepsy, or multiple sclerosis).
- Present use of prescribed stimulants (e.g., methylphenidate or amphetamines)
- Present use of prescribed dopamine agonists/antagonists other than amantadine
- For participants with childbearing capacity, pregnancy (for MRI and PET procedures) or nursing (for PET procedures only)
- Contraindication to PET procedures (for PET procedures only)
- Contraindication to MRI procedures as per MRI Center screening questionnaire (for MRI procedures only)
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- Inability to participate in at least two of the imaging procedures (PET, MRI or MEG) due to contraindications
- Staff from our section
- For TBI patients, history of a penetrating head wound
- For healthy volunteers, history of any type of traumatically induced head injury resulting in presentation to an Emergency Department within 24 hours of the injury event
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Neural Basis of Decision Making Deficits in Traumatic Brain Injury
Background:
People with a traumatic brain injury (TBI) can have trouble making the best possible decisions. Researchers want to learn more about the parts of the brain that control decision making. They also want to know how these are different between people. This may help predict how people make decisions after TBI.
Read more
Objective:
To learn more about which parts of the brain are involved in making decisions and how decisions may be hurt after TBI.
Eligibility:
Adults age 18 to 60.
Design:
Participants will be screened with medical history and physical exam. They will also take memory, attention, concentration, and thinking tests.
Participants will do up to 2 experiments.
For Experiment 1, participants may have 3 scans:
PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a bed that slides in and out of the scanner.
MRI: a strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a metal cylinder. It makes loud knocking noises. Participants will get earplugs. They might be asked to do a task. A coil will be placed over the head.
MEG: a cone with magnetic field detectors is lowered onto participants head.
After the scans, participants will perform a decision-making task.
For Experiment 2, participants will perform a decision-making task before and after receiving transcranial direct current stimulation (tDCS).
tDCS: wet electrode sponges are placed over participants' scalp and forehead. A current passes between the electrodes. It stimulating the brain.
Participants will return 24-48 hours later to repeat the decision-making task.
Read the detailed description
Study Description:
Deficits in decision-making are commonly found in individuals after traumatic brain injury (TBI) and can have a severe negative impact on quality of life. Converging evidence from both animal model and human studies suggest that decision-making deficits are linked with abnormal mesocorticolimbic network structure and function, and could potentially be mitigated through interventions that improve function within these neuronal circuits.
Objectives:
- Quantify differences in performance on a decision-making task between TBI patients and healthy volunteers;
- Determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and
- Determine if facilitatory transcranial direct current stimulation (tDCS) applied over the dorsolateral prefrontal cortex (dlPFC), a mesocorticolimbic network region crucially involved in decision-making, improves decision-making after TBI.
Endpoints:
Primary Endpoint: The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.
Secondary Endpoints: Secondary outcome measures will include quantitative estimates of structural and functional mesocorticolimbic network features, including MRI-based structural and functional connectivity, MEG-based functional connectivity, baseline dlPFC GABA concentration measured with magnetic resonance spectroscopy (MRS) imaging, dopamine D2 receptor binding potential within mesocorticolimbic subcortical nuclei measured with [11C]raclopride PET (Experiment 1). Multimodal data fusion modeling will be used to explore the predictive relationship between baseline mesocorticolimbic network features and decision-making task performance within a unified state-space framework (Experiment 1), as well as the ability of these network features to predict inter-individual differences in the effects of tDCS on decision-making task performance (Experiment 2).
- Conditions
- Traumatic Brain Injury
- Being tested
- tDCS, [11C] Raclopride
- Keywords
- Traumatic Brain Injury, Decision-Making, Dopaminergic Network, Brain Imaging, Non-Invasive Brain Stimulation, Natural History
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
There is no study intervention for Experiment 1. The study intervention for Experiment 2 is tDCS. tDCS is a non-invasive brain stimulation technique that uses electrodes attached to the scalp to deliver very low intensity direct current to the brain. This intervention has been demonstrated to result in neuromodulatory effects.
[11C] RacloprideDrug
[11C] Raclopride is administered under an IND 054135. This IND is sponsored by the NIH Clinical Center and [11C] Raclopride is dispensed by the NIH PET Department. Quality Assurance for Radioactive Drug: [11C] Raclopride, is assayed for radiochemical purity under the supervision of the NIH PET Department prior to dispensing the drug for administration. Given that IND PET drugs manufactured at the NIH PET Department are used in a single site and that there is no intent for their commercialization, submission of IBs has not been required by FDA for any of the NIH Office of Research Support and Compliance-sponsored IND applications.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | up to 40 adult TBI patients between the ages of 18 and 60 Receives: Device: tDCS; Drug: [11C] Raclopride |
| 2 | Active comparator | up to 40 adult healthy volunteers between the ages of 18 and 60 Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers.
The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.
Measured: Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.
Secondary outcomes (1)
The secondary objectives of this protocol are to: determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and determine i...
Secondary outcome measures will include quantitative estimates of structural and functional mesocorticolimbic network features, including MRI-based structural and functional connectivity, MEG-based functional dynamics, baseline dlPFC GABA concentration measured with magnetic resonance spectroscopy (MRS) imaging, dopamine D2 receptor binding potential within mesocorticolimbic subcortical nuclei measured with [11C]raclopride PET (Experiment 1). Multimodal data fusion modeling will be used to explore the predictive relationship between baseline mesocorticolimbic network states and decision-making performance within a unified state-space framework (Experiment 1), as well as the ability of these network states to predict inter-individual differences in the effects of tDCS on decision-making performance (Experiment 2).
Measured: Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start18 Nov 2014
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
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 National Institute of Neurological Disorders and Stroke (NINDS)The 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Leonardo G Cohen, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169310
- Sponsor's protocol ID
- 140083
- Other IDs
- 14-N-0083
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2014
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Basis of Decision Making Deficits in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02169310
- Acronym / sponsor ID
- 140083
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Decision-Making, Dopaminergic Network, Brain Imaging, Non-Invasive Brain Stimulation, Natural History
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 23 Jun 2014 (estimated)
- 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.
Background:
People with a traumatic brain injury (TBI) can have trouble making the best possible decisions. Researchers want to learn more about the parts of the brain that control decision making. They also want to know how these are different between people. This may help predict how people make decisions after TBI.
Objective:
To learn more about which parts of the brain are involved in making decisions and how decisions may be hurt after TBI.
Eligibility:
Adults age 18 to 60.
Design:
Participants will be screened with medical history and physical exam. They will also take memory, attention, concentration, and thinking tests.
Participants will do up to 2 experiments.
For Experiment 1, participants may have 3 scans:
PET: a chemical is injected through a thin tube into an arm vein. Participants lie on a bed that slides in and out of the scanner.
MRI: a strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a metal cylinder. It makes loud knocking noises. Participants will get earplugs. They might be asked to do a task. A coil will be placed over the head.
MEG: a cone with magnetic field detectors is lowered onto participants head.
After the scans, participants will perform a decision-making task.
For Experiment 2, participants will perform a decision-making task before and after receiving transcranial direct current stimulation (tDCS).
tDCS: wet electrode sponges are placed over participants' scalp and forehead. A current passes between the electrodes. It stimulating the brain.
Participants will return 24-48 hours later to repeat the decision-making task.
Detailed description
Study Description:
Deficits in decision-making are commonly found in individuals after traumatic brain injury (TBI) and can have a severe negative impact on quality of life. Converging evidence from both animal model and human studies suggest that decision-making deficits are linked with abnormal mesocorticolimbic network structure and function, and could potentially be mitigated through interventions that improve function within these neuronal circuits.
Objectives:
- Quantify differences in performance on a decision-making task between TBI patients and healthy volunteers;
- Determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and
- Determine if facilitatory transcranial direct current stimulation (tDCS) applied over the dorsolateral prefrontal cortex (dlPFC), a mesocorticolimbic network region crucially involved in decision-making, improves decision-making after TBI.
Endpoints:
Primary Endpoint: The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.
Secondary Endpoints: Secondary outcome measures will include quantitative estimates of structural and functional mesocorticolimbic network features, including MRI-based structural and functional connectivity, MEG-based functional connectivity, baseline dlPFC GABA concentration measured with magnetic resonance spectroscopy (MRS) imaging, dopamine D2 receptor binding potential within mesocorticolimbic subcortical nuclei measured with [11C]raclopride PET (Experiment 1). Multimodal data fusion modeling will be used to explore the predictive relationship between baseline mesocorticolimbic network features and decision-making task performance within a unified state-space framework (Experiment 1), as well as the ability of these network features to predict inter-individual differences in the effects of tDCS on decision-making task performance (Experiment 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: tDCS, Drug: [11C] Racloprideup to 40 adult TBI patients between the ages of 18 and 60 |
| 2 | Active comparator | Device: tDCSup to 40 adult healthy volunteers between the ages of 18 and 60 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age 18 to 60
- Able to give consent
- Must be able to follow instructions and perform required tasks
- Absence of clinically significant abnormalities during neurological examination
- Age 18 to 60
Key exclusion criteria (10 listed)
- Pre-existing and disabling major psychiatric (e.g., schizophrenia, bipolar disorder or post-traumatic stress disorder) or neurological disease (e.g., stroke, dementia, epilepsy, or multiple sclerosis).
- Present use of prescribed stimulants (e.g., methylphenidate or amphetamines)
- Present use of prescribed dopamine agonists/antagonists other than amantadine
- For participants with childbearing capacity, pregnancy (for MRI and PET procedures) or nursing (for PET procedures only)
- Contraindication to PET procedures (for PET procedures only)
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 |
|---|---|---|
| tDCSThere is no study intervention for Experiment 1. The study intervention for Experiment 2 is tDCS. tDCS is a non-invasive brain stimulation technique that uses electrodes attached to the scalp to deliver very low intensity direct current to the brain. This intervention has been demonstrated to result in neuromodulatory effects. | Device | 1, 2 |
| [11C] Raclopride[11C] Raclopride is administered under an IND 054135. This IND is sponsored by the NIH Clinical Center and [11C] Raclopride is dispensed by the NIH PET Department. Quality Assurance for Radioactive Drug: [11C] Raclopride, is assayed for radiochemical purity under the supervision of the NIH PET Department prior to dispensing the drug for administration. Given that IND PET drugs manufactured at the NIH PET Department are used in a single site and that there is no intent for their commercialization, submission of IBs has not been required by FDA for any of the NIH Office of Research Support and Compliance-sponsored IND applications. | Drug | 1 |
Primary outcome
The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers.
Time frame: Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.
The primary outcome measure for both Experiment 1 and 2 is performance in a computerized decision-making task.
1 secondary outcome
The secondary objectives of this protocol are to: determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers; and determine i...
Time frame: Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Leonardo G Cohen, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS and [11C] Raclopride in people with Traumatic Brain Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 15 inclusion and 10 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: finished, as of the sponsor's last update on 22 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this protocol is to: quantify differences in performance on a decision-making task between TBI patients and healthy volunteers. (time frame: Participation may be completed over the course of a week, or longer depending on participant s schedule and testing availability. Typically, individuals complete the full study with 4-7 days.). 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 22 Aug 2025.