- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05929898
MRI Neurofeedback and Brain Circuits Related to Motivation in Healthy Participants
Bridging Scales to Understand Endogenous Neuromodulation and Its Regulation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Yost
- Phone Number: 919-681-4601
- Email: laura.yost@duke.edu
Study Contact Backup
- Name: R. Alison Adock, MD, PhD
- Phone Number: 919-681-4601
- Email: alison.adcock@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Recruiting
- Center for Cognitive Neuroscience
-
Contact:
- R. Alison Adcock, MD, PhD
- Phone Number: 919-661-4601
- Email: alison.adcock@duke.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intentional Versus Cue-Evoked Midbrain Activation
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.
|
fMRI neurofeedback training of sustained midbrain/VTA activation via motivational imagery.
|
|
Experimental: Intentional Midbrain Activation Effects on Effort-Based Decision Making
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.
|
fMRI neurofeedback training of sustained midbrain/VTA activation via motivational imagery.
|
|
Experimental: Intentional Midbrain Activation Effects on Motivated Memory
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, .
|
fMRI neurofeedback training of sustained midbrain/VTA activation via motivational imagery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent signal change in VTA BOLD activation
Time Frame: During the MRI scan, approximately 2 hours
|
During the MRI scan, approximately 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in effort-based decision making, as measured by the Effort Expenditure for Reward Task (EEfRT)
Time Frame: During the MRI scan, approximately 2 hours
|
Decisions to exert effort.
|
During the MRI scan, approximately 2 hours
|
|
Change in motivated memory, as measured by the Monetary Incentive Encoding task (MIE)
Time Frame: During the MRI scan, approximately 2 hours
|
Improved motivated memory formation.
|
During the MRI scan, approximately 2 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: R. Alison Adock, MD, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00112672
- 1R01MH131667-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Motivation
-
Centre Hospitalier Universitaire de NiceLaboratoire Motricité Humaine, Expertise, Sport, Santé (LAMHESS); Côte d'Azur...Not yet recruiting
-
Nourhan M.AlyAlexandria UniversityCompleted
-
University of Southern DenmarkUnknown
-
University of AmsterdamKwaliteit Forensische Zorg JeugdRecruiting
-
Temple UniversityNational Institute on Drug Abuse (NIDA)Completed
-
ThinkWellUniversity of Oxford; Queen's University, Belfast; The BMJCompleted
-
Kahramanmaras Sutcu Imam UniversityRecruiting