Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648460
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Multimodal Differences in Effort-based Decision-Making in Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal Differences in Effort-based Decision-Making in Depression - - Brain Behavior Quantification and Synchronization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBQS
Brief Summary:
Major depressive disorder MDD is a serious condition that causes long-term symptoms such as feeling sad losing interest in activities and having thoughts of self-harm Difficulty in making an effort is a key factor in functional impairment Current methods to evaluate this difficulty use clinical assessments and computer-based tasks but there is a gap between the measurements and real-life behavior To address this the study team proposes creating an instrumented behavioral test HORMES to objectively assess reduced motivation during everyday activities and measure physiological responses The study will examine differences in brain activity autonomic system function and metabolic energy expenditure in patients with major depression during a decision-making task that involves physical effort
Detailed Description:
Major depressive disorder MDD is a debilitating neuropsychiatric condition characterized by multiple chronic symptoms including sad mood anhedonia psychomotor symptoms and suicidal thoughts MDD induces significant personal and societal suffering becoming the largest contributor to the overall disease burden in developed countries There is clearly an urgent need to advance our understanding of MDD and its constituent symptoms Of these the inability to expend effort have proven harder to treat than mood-related symptoms and are key predictors of functional impairment and disease burden The biological mechanisms that contribute to this impairment are not fully understood Addressing this gap in knowledge will be helpful in developing therapy including novel brain stimulation therapies that offer the ability to target brain circuits precisely
Current evaluation approaches to characterizing reduced motivation rely on clinical assessments of patient symptoms through interviews and observation While these typically assess functions relevant to patient quality of life these assessments may be confounded by biases On the other hand translational research focuses on characterizing symptoms using computer-based tasks that provide quantitative objective markers eg reaction time in pressing a key on a keyboard but may not reflect real-life situations In addition studies investigating brain mechanisms often use functional magnetic resonance imaging fMRI which requires patients to be stationary Thus there is a fundamental disconnect between measurements of behavior and the behavior itself under study
To overcome these limitations the study team envisions developing an instrumented behavioral assay HORMES that allows the objective assessment of reduced motivation during naturalistic behavior with concurrent measurements of the central and autonomic nervous systems as well as metabolic energy expenditure This assay will utilize a CAREN system at Human Augmentation Core a core facility available at Georgia Tech that is currently used for biomechanics research
The proposed study will investigate differences in brain activity autonomic system function and metabolic energy expenditure in patients with major depression and matched controls during an effort-based decision-making task The study team will collect multiple physiological measures - brain activity cardiac activity breathing activity and energy expenditure in patients with major depression when they walk on a treadmill Biomechanical information will be obtained using motion capture The amount of effort they will need to expend will be varied by adjusting the treadmills incline These measures will be compared against those from a control group with age gender and BMI-matched healthy individuals
The outcome of this study will inform what differences exist between healthy individuals and individuals with depression The participants will be recruited from the Atlanta metro area and will all be allocated to the intervention which is a behavioral task The task requires participants to maximize rewards by choosing to pursue actions of different levels of physical effort walking
Current evaluation approaches to characterizing reduced motivation rely on clinical assessments of patient symptoms through interviews and observation While these typically assess functions relevant to patient quality of life these assessments may be confounded by biases On the other hand translational research focuses on characterizing symptoms using computer-based tasks that provide quantitative objective markers eg reaction time in pressing a key on a keyboard but may not reflect real-life situations In addition studies investigating brain mechanisms often use functional magnetic resonance imaging fMRI which requires patients to be stationary Thus there is a fundamental disconnect between measurements of behavior and the behavior itself under study
To overcome these limitations the study team envisions developing an instrumented behavioral assay HORMES that allows the objective assessment of reduced motivation during naturalistic behavior with concurrent measurements of the central and autonomic nervous systems as well as metabolic energy expenditure This assay will utilize a CAREN system at Human Augmentation Core a core facility available at Georgia Tech that is currently used for biomechanics research
The proposed study will investigate differences in brain activity autonomic system function and metabolic energy expenditure in patients with major depression and matched controls during an effort-based decision-making task The study team will collect multiple physiological measures - brain activity cardiac activity breathing activity and energy expenditure in patients with major depression when they walk on a treadmill Biomechanical information will be obtained using motion capture The amount of effort they will need to expend will be varied by adjusting the treadmills incline These measures will be compared against those from a control group with age gender and BMI-matched healthy individuals
The outcome of this study will inform what differences exist between healthy individuals and individuals with depression The participants will be recruited from the Atlanta metro area and will all be allocated to the intervention which is a behavioral task The task requires participants to maximize rewards by choosing to pursue actions of different levels of physical effort walking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None