Clinical trial NCT05934604: Targeting Large-scale Networks in Depression With Real-time fMRI (Functional Magnetic Resonance Imaging) Neurofeedback
Official title: Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Keywords: Healthy
fMRI
Neurofeedback
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Detailed description: During the second phase of the project healthy participants (approximately 12) will have three study visits (two fMRIs) over 2-4 weeks.

Note: As the study is a feasibility/development study, alterations of the task design for the primary outcome measures will be done to achieve objectives of developing at task that recruits from the target region (salience network). In phase 1 of the study, changes to the task are ongoing, and the same may occur for phase 2 in order to develop a viable neurofeedback paradigm. Therefore, detailed descriptions of the outcome measures are not entered at this time, as we don't know exactly what those are. When we do, the entry will be updated.

Note: As of 7/26/2024, the study is rolling back from 'Completed' to 'Recruiting' status in order to include more healthy controls and temporarily resume active development of the task design.

Eligibility criteria: Inclusion Criteria (phase 2 participants):

* Ability and willingness to give informed consent to participate
* Not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed)
* If a woman of child-bearing age, not pregnant or trying to become pregnant
* 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
* No history of closed head injury (see protocol for more details)
* Ability to tolerate small, enclosed spaces without anxiety
* 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
* 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

Primary outcomes:
measure: Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session
timeFrame: Approximately 40 minutes (during MRI)
measure: BOLD signal change during the Focus>Rest contrast, comparing baseline with transfer runs (no NF in either), during the rtfMRI-NF session
timeFrame: Approximately 40 minutes (during MRI)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephan Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: