NCT05929898

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2023Sep 2026

First Submitted

Initial submission to the registry

June 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2026

Last Updated

August 22, 2025

Status Verified

May 1, 2025

Enrollment Period

3.1 years

First QC Date

June 26, 2023

Last Update Submit

August 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent signal change in VTA BOLD activation

    During the MRI scan, approximately 2 hours

Secondary Outcomes (2)

  • Change in effort-based decision making, as measured by the Effort Expenditure for Reward Task (EEfRT)

    During the MRI scan, approximately 2 hours

  • Change in motivated memory, as measured by the Monetary Incentive Encoding task (MIE)

    During the MRI scan, approximately 2 hours

Study Arms (3)

Intentional Versus Cue-Evoked Midbrain Activation

EXPERIMENTAL

Participants meeting study inclusion will be scheduled for two sessions: one baseline behavioral visit and an fMRI session to assess the ability to self-stimulate VTA activation. Session one will include a battery of cognitive assessments and a demonstration of the reward-based learning task in session two. The experimental imaging task session will be done within one week of session one. Participants will been randomly split into two group: group one will complete a reward-based learning task before the VTA activation task and group two will complete reward task after VTA activation. During the VTA activation task, participants will be instructed to achieve a heightened state of motivation using personally relevant thoughts and imagery.

Behavioral: Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback

Intentional Midbrain Activation Effects on Effort-Based Decision Making

EXPERIMENTAL

Participants will be randomly assigned to an MRI group or a behavioral control group. All participants will complete an effort-based learning task and a series of questionnaires in session one. Session two may include an MRI based on group assignment. Participants in the MRI group will complete the VTA activation task. Following, they will complete the effort task and questionnaires a second time. The behavioral control group will complete a second session consisting of the effort task and questionnaires.

Behavioral: Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback

Intentional Midbrain Activation Effects on Motivated Memory

EXPERIMENTAL

Participants will take part in four sessions: visit 1-baseline + memory encoding, visit 2-memory retrieval, visit 3-memory encoding, visit 4-memory retrieval). Encoding and retrieval of the memoranda will occur 24 hours apart. Study visits will take place no more than 7 days apart. One group of participants will complete all sessions at the Center for Cognitive Neuroscience. The remainder of participants will complete the encoding sessions in the MRI machine, .

Behavioral: Ventral tegmental area of dopaminergic midbrain (VTA) fMRI neurofeedback

Interventions

fMRI neurofeedback training of sustained midbrain/VTA activation via motivational imagery.

Intentional Midbrain Activation Effects on Effort-Based Decision MakingIntentional Midbrain Activation Effects on Motivated MemoryIntentional Versus Cue-Evoked Midbrain Activation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Current or diagnosis within past six months of an DSM-V Axis I or Axis II disorder (self-reported)
  • CES-D score of 20 or higher (indicating significant current depression symptoms)
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cognitive Neuroscience

Durham, North Carolina, 27708, United States

RECRUITING

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • R. Alison Adock, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

R. Alison Adock, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 3, 2023

Study Start

July 30, 2023

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 9, 2026

Last Updated

August 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations