Targeting Large-scale Networks in Depression With Real-time fMRI (Functional Magnetic Resonance Imaging) Neurofeedback
Study Details
Study Description
Brief Summary
The purpose of this study is to develop a technique called real time fMRI neurofeedback.
This technique uses a functional MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms.
This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial.
Therefore, this registration will include phase 2 at this time.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
During the second phase of the project healthy participants (approximately 12) will have three study visits (two fMRIs) over 2-4 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Magnetic resonance imaging (MRI) group Healthy volunteers will have two functional magnetic resonance imaging scans (localizer session and the real time functional magnetic resonance imaging neurofeedback session). |
Other: Functional magnetic resonance imaging (fMRI)
Healthy subjects will complete two fMRI sessions after initial assessment and training in the Recall Stop Task (RST). The first session will be the localizer session to identify the networks involved in switching in the RST. The second fMRI session, real time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) session, will use localizer information from the first fMRI session to develop a mask for the rtfMRI-NF, and deliver a neurofeedback (NF) stimulus while simultaneously measuring Blood Oxygenation Level Dependent (BOLD) activity for the STOP>RECALL contrast.
|
Outcome Measures
Primary Outcome Measures
- Blood Oxygen Level Dependent (BOLD) signal change during the stop greater (>) RECALL contrast during the localizer session [Approximately 40 minutes (during MRI)]
- BOLD signal change during the stop>recall contrast, comparing baseline with transfer runs (no NF in either), during the rtfMRI-NF session [Approximately 40 minutes (during MRI)]
Secondary Outcome Measures
- Neurofeedback signal (moving window for each stop>recall trial pair) during the rtfMRI-NF session [Approximately 40 minutes (during the second MRI)]
Eligibility Criteria
Criteria
Inclusion Criteria (phase 2 participants):
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Ability and willingness to give informed consent to participate
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Not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed)
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If a woman of child-bearing age, not pregnant or trying to become pregnant
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No history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure
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No history of closed head injury (see protocol for more details)
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Ability to tolerate small, enclosed spaces without anxiety
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No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition
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Size compatible with scanner gantry
Exclusion Criteria (phase 2 participants):
- History of past or current mental illness (except for simple phobias), but prior history of substance dependence ok if in remission for greater than 5 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Stephan Taylor, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00228741