Healthy ParticipantsNCT05934604
Targeting Large-scale Networks in Depression With Real-time fMRI (Functional Magnetic Resonance Imaging) Neurofeedback
A study testing Functional magnetic resonance imaging (fMRI) in people with Healthy Participants, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Functional magnetic resonance imaging (fMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- Functional magnetic resonance imaging (fMRI)
- Keywords
- Healthy, fMRI, Neurofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging (fMRI)Other
Healthy subjects will complete two fMRI sessions after initial assessment and training in the Rest Focus Task (RFT). The first session will be the localizer session to identify the networks involved in switching in the RFT. 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.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging (MRI) group | Experimental | Healthy volunteers will have two functional magnetic resonance imaging scans (localizer session and the real time functional magnetic resonance imaging neurofeedback session). Receives: Other: Functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session
Measured: Approximately 40 minutes (during MRI)
BOLD signal change during the Focus>Rest contrast, comparing baseline with transfer runs (no NF in either), during the rtfMRI-NF session
Measured: Approximately 40 minutes (during MRI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start9 Oct 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan F. Taylor, University of Michigan
- Investigators
- Stephan Taylor, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934604
- Sponsor's protocol ID
- HUM00228741
- Status last verified
- Nov 2024
- First submitted
- 28 Jun 2023
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback
- ClinicalTrials.gov ID
- NCT05934604
- Acronym / sponsor ID
- HUM00228741
- Conditions
- Healthy Participants
- Keywords
- Healthy, fMRI, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging (MRI) group | Experimental | Other: Functional magnetic resonance imaging (fMRI)Healthy volunteers will have two functional magnetic resonance imaging scans (localizer session and the real time functional magnetic resonance imaging neurofeedback session). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imaging (fMRI)Healthy subjects will complete two fMRI sessions after initial assessment and training in the Rest Focus Task (RFT). The first session will be the localizer session to identify the networks involved in switching in the RFT. 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. | Other | Magnetic resonance imaging (MRI) group |
Primary outcome
Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session
Time frame: Approximately 40 minutes (during MRI)
BOLD signal change during the Focus>Rest contrast, comparing baseline with transfer runs (no NF in either), during the rtfMRI-NF session
Time frame: Approximately 40 minutes (during MRI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Taylor, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging (fMRI) in people with Healthy Participants, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session (time frame: Approximately 40 minutes (during MRI)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.