MRI Neurofeedback and Brain Circuits Related to Motivation in Healthy Participants

Motivation Clinical Trial

Official title:

Bridging Scales to Understand Endogenous Neuromodulation and Its Regulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929898
• Other study ID #: Pro00112672
• Secondary ID: 1R01MH131667-01
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2023
• Est. completion date: September 9, 2026

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Laura Yost
• Phone: 919-681-4601
• Email: laura.yost[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: September 9, 2026
• Est. primary completion date: September 8, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Memory
• Motivation
• Self-regulation

Intervention

Behavioral:
• Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback
fMRI neurofeedback training of sustained midbrain/VTA activation via motivational imagery.

Locations

Country	Name	City	State
United States	Center for Cognitive Neuroscience	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent signal change in VTA BOLD activation		During the MRI scan, approximately 2 hours
Secondary	Change in effort-based decision making, as measured by the Effort Expenditure for Reward Task (EEfRT)	Decisions to exert effort.	During the MRI scan, approximately 2 hours
Secondary	Change in motivated memory, as measured by the Monetary Incentive Encoding task (MIE)	Improved motivated memory formation.	During the MRI scan, approximately 2 hours