Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02169310
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2014-06-19
Brief Title:
Neural Basis of Decision-Making Deficits in Traumatic Brain Injury
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neural Basis of Decision Making Deficits in Traumatic Brain Injury
Status:
COMPLETED
Status Verified Date:
2024-09-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
1 Quantify differences in performance on a decision-making task between TBI patients and healthy volunteers
2 Determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers and
3 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 11Craclopride 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
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
1 Quantify differences in performance on a decision-making task between TBI patients and healthy volunteers
2 Determine whether baseline features of mesocorticolimbic network structure and function predict subsequent decision-making performance in both TBI patients and healthy volunteers and
3 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 11Craclopride 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-N-0083 | None | None | None |