Clinical trial NCT05929898: MRI Neurofeedback and Brain Circuits Related to Motivation in Healthy Participants
Official title: Bridging Scales to Understand Endogenous Neuromodulation and Its Regulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motivation
Memory
Self-regulation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-07-03
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to understand how healthy individuals self-regulate motivation by observing brain activity using magnetic resonance imaging (MRI).

Detailed description: Neuromodulatory nuclei detect and transform brain network activity into simpler signals, then send neurotransmitters back out to large-scale brain networks to change their function. Such nuclei are centrally implicated in mental disorders and adaptive resilience, and their regulation remains an untapped resource for interventions. The purpose of this study is to understand how neuromodulatory nuclei detect and in turn influence distributed patterns of brain activity to impact behavior. In order to understand their regulation and effects on brain function, the investigative team has developed novel neuroimaging, behavioral, and analytic methods. These methods include: training participants to endogenously self-regulate dopaminergic midbrain and then relating midbrain activation to memory-conducive states, effort exertion, and decision making.

If the aims of this project are achieved, the investigators will have methods for regulating midbrain noninvasively, an improved understanding of its impact on learning and motivated behavior, and reliable cognitive strategies for a wide array of interventions across educational and clinical applications.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years
* Male or female
* Right-handed
* In good general health
* Women of childbearing capacity: use of effective method of birth control

Exclusion Criteria:

* Current or diagnosis within past six months of an DSM-V Axis I or Axis II disorder (self-reported)
* Current or past six month use of prescription medications indicated for psychiatric conditions (e.g.,depression, anxiety)
* Current serious medical illness (self-reported)
* Head injury resulting in loss of consciousness
* For participants age \> 59 years, a total scaled score \< 8 on the Dementia Rating Scale-2.
* A clinically-defined neurological disorder including, but not limited to:
* Any condition likely to be associated with increased intracranial pressure
* Space occupying brain lesion
* History of stroke
* Transient ischemic attack within two years
* Cerebral aneurysm
* Dementia
* Mini Mental Status Exam (MMSE) score of \<24
* Parkinson's disease
* Huntington's disease
* Multiple sclerosis
* Presence of cochlear implants or other implanted electronic devices or non-removable metal (e.g., non-removable piercing, IUD)
* History of an eye injury involving metal. Participants who worked with metal may be allowed to participate on a case-by-case basis with prior written approval from BIAC.
* Claustrophobia or unwillingness to tolerate the confinement associated with being in the MRI scanner.
* Weight of more than 250 pounds

Primary outcomes:
measure: Percent signal change in VTA BOLD activation
timeFrame: During the MRI scan, approximately 2 hours
Secondary outcomes:
measure: Change in effort-based decision making, as measured by the Effort Expenditure for Reward Task (EEfRT)
timeFrame: During the MRI scan, approximately 2 hours
measure: Change in motivated memory, as measured by the Monetary Incentive Encoding task (MIE)
timeFrame: During the MRI scan, approximately 2 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Center for Cognitive Neuroscience
state: North Carolina
Study officials:
affiliation: Duke University
name: R. Alison Adock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: