Major Depressive DisorderBiofeedbackNCT04138680
Real-time Biofeedback With 7-Tesla MRI for Treatment of Depression
A study testing Active Biofeedback in people with Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Active Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2019to 11 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years;
- Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
- Male or female aged 18-65 years;
- Does not meet for any current or past psychiatric diagnoses as defined by DSM-5 criteria as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
Who cannot join
- Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients and for healthy control subjects: any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
- Active substance use disorder within the past 6 months;
- Concomitant use of any medication with central nervous system activity within 1 week of scan;
- Positive urine toxicology screen for drugs of abuse at the time of screening;
- Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
- Women who are pregnant;
- Any contraindications to MRI, including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, inability to lie still for 1 hour or more, and inability to fit in the MRI scanner.
- Patients who are currently hospitalized on the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court ordered.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Real-time Biofeedback With 7-Tesla MRI for Neurocircuit Based Treatment of Depression
Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.
Read the detailed description
Major depressive disorder (MDD) is the world's largest health problem, and current available treatments fail at relieving symptoms for many patients. The best medical approach will depend on taking an individualized approach to treatment, targeting core symptoms such as reduced self-driven motivation. In rodent studies of depression, problems with motivation have been linked to the activity of the ventral tegmental area (VTA), a small part of the brain that releases dopamine and guides decision making for rewards. However, there have been barriers in examining the VTA in humans because current MRI scanners are relatively low-resolution. Therefore, the researchers have recently developed an ultra-high field MRI procedure that provides improved images of the VTA, compared to current standard MRI procedures.
The study team now intend to further this work by conducting a randomized controlled trial that will help train individuals with MDD to modulate their own VTA activity during an ultra-high field MRI scanning session. Previous studies have shown that the activity of the VTA can be changed in healthy volunteers if they are trained to use certain thought patterns while watching their own VTA activity in 'real-time'. This procedure is called real-time biofeedback The research question is whether this same type of training is feasible in patients with MDD with ultra-high field MRI, and whether it can influence measures of motivation.
Aim 1. To determine the feasibility of VTA self-regulation. The study team will recruit 30 patients with MDD and 15 will receive VTA real-time biofeedback whereas the other 15 will receive a different, control feedback. Participants will be trained to "generate a heightened state of motivation" and will simultaneously view a progress bar on the screen that represents their VTA activity. They will be trained to try to increase the level of the bar by motivating themselves. The investigators expect that the group receiving VTA real-time biofeedback will show a greater increase in VTA activity self-regulation compared to the group with non-VTA, control feedback.
Aim 2. To determine the impact of VTA self-regulation on motivation. The research team will test levels of motivation using novel, validated computerized tasks before and after the real-time biofeedback training session. The researchers will also explore a measure of mood using a validated questionnaire, and as well as assess levels of clinical depression severity by a trained clinician. The investigators expect that individuals who show a greater increase in VTA activity self-regulation will also show an increase in motivation after training.
If this real-time biofeedback tool is shown to be possible for changing VTA activity in patients with MDD, this work will provide a critical next step in individualized treatment for depression. By exploring how changes in VTA activity self-regulation relate to changes in motivation, the researchers will show how the brain works to regulate important behaviors associated with depression. Ultimately, this work is expected to provide new ways to treat patients with depression.
- Conditions
- Major Depressive Disorder
- Being tested
- Active Biofeedback, Sham Biofeedback
- Keywords
- Brain Imaging, Biofeedback
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active BiofeedbackBehavioural
The active biofeedback session will be done within the 7T MRI. It will include a pre-training run, 3 training runs, and a post-training run. Each run will be comprised of MOTIVATE and REST trials. During each MOTIVATE trial, subjects will be instructed to "generate a heightened state of motivation". Participants will be encouraged to identify strategies that are personally relevant or useful and to monitor the efficacy of the strategies. Subjects will simultaneously view a progress bar on the screen during MOTIVATE trials that represents their VTA activity and they will be trained to try to increase the level of the bar by motivating themselves. For the active VTA biofeedback group, the progress bar will be updated every second to accurately convey level of VTA signal activation. During REST trials, all subjects will be instructed to count backwards. During the post-training 'test' run, subjects will be instructed to use the strategies they found to be most effective.
Sham BiofeedbackBehavioural
The sham biofeedback session resembles the active condition, however, the thermometer seen during the MOTIVATE trials will represent yoked sham values.
| Study group | Role | What they receive |
|---|---|---|
| Active Biofeedback | Experimental | The patients in the active group will receive one active biofeedback training session. Receives: Behavioral: Active Biofeedback |
| Sham Biofeedback | Sham comparator | The patients in the sham group will receive one sham biofeedback training session. Receives: Behavioral: Sham Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Increase in VTA Activation during MOTIVATE trials
For each subject, the % increase in VTA activation during MOTIVATE trails at post-training compared to pre-training will be computed ([MOTIVATEpost>RESTpost] > [MOTIVATEpre>RESTpre]), indicating the efficacy of training on VTA activity self- regulation. This measure of VTA activity self-regulation from pre to post training will be entered into an independent samples t-test to compare between active and control feedback groups.
Measured: baseline (Pre-training) and 2 hours (Post-training) during the assessment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start9 Oct 2019
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind sham controlled randomized trial
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurel Morris, Icahn School of Medicine at Mount Sinai
- Investigators
- Laurel Morris, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138680
- Sponsor's protocol ID
- GCO 19-0616
- Other IDs
- Study-19-00401
- Acronym
- Biofeedback
- Status last verified
- Sep 2024
- First submitted
- 22 Oct 2019
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Biofeedback With 7-Tesla MRI for Neurocircuit Based Treatment of Depression
- ClinicalTrials.gov ID
- NCT04138680
- Acronym / sponsor ID
- Biofeedback / GCO 19-0616
- Conditions
- Major Depressive Disorder
- Keywords
- Brain Imaging, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 24 Oct 2019 (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.
Previous research has shown that modulation of a brain region in rodents, the ventral tegmental area (VTA), improves depressive symptoms. Human research has also shown that VTA self-modulation using 'biofeedback' is feasible and successful in healthy volunteers. This biofeedback procedure is a type of cognitive training that includes real-time feedback about brain signal levels from the VTA. Our question is whether VTA self-modulation with biofeedback can influence depression symptoms.
Detailed description
Major depressive disorder (MDD) is the world's largest health problem, and current available treatments fail at relieving symptoms for many patients. The best medical approach will depend on taking an individualized approach to treatment, targeting core symptoms such as reduced self-driven motivation. In rodent studies of depression, problems with motivation have been linked to the activity of the ventral tegmental area (VTA), a small part of the brain that releases dopamine and guides decision making for rewards. However, there have been barriers in examining the VTA in humans because current MRI scanners are relatively low-resolution. Therefore, the researchers have recently developed an ultra-high field MRI procedure that provides improved images of the VTA, compared to current standard MRI procedures.
The study team now intend to further this work by conducting a randomized controlled trial that will help train individuals with MDD to modulate their own VTA activity during an ultra-high field MRI scanning session. Previous studies have shown that the activity of the VTA can be changed in healthy volunteers if they are trained to use certain thought patterns while watching their own VTA activity in 'real-time'. This procedure is called real-time biofeedback The research question is whether this same type of training is feasible in patients with MDD with ultra-high field MRI, and whether it can influence measures of motivation.
Aim 1. To determine the feasibility of VTA self-regulation. The study team will recruit 30 patients with MDD and 15 will receive VTA real-time biofeedback whereas the other 15 will receive a different, control feedback. Participants will be trained to "generate a heightened state of motivation" and will simultaneously view a progress bar on the screen that represents their VTA activity. They will be trained to try to increase the level of the bar by motivating themselves. The investigators expect that the group receiving VTA real-time biofeedback will show a greater increase in VTA activity self-regulation compared to the group with non-VTA, control feedback.
Aim 2. To determine the impact of VTA self-regulation on motivation. The research team will test levels of motivation using novel, validated computerized tasks before and after the real-time biofeedback training session. The researchers will also explore a measure of mood using a validated questionnaire, and as well as assess levels of clinical depression severity by a trained clinician. The investigators expect that individuals who show a greater increase in VTA activity self-regulation will also show an increase in motivation after training.
If this real-time biofeedback tool is shown to be possible for changing VTA activity in patients with MDD, this work will provide a critical next step in individualized treatment for depression. By exploring how changes in VTA activity self-regulation relate to changes in motivation, the researchers will show how the brain works to regulate important behaviors associated with depression. Ultimately, this work is expected to provide new ways to treat patients with depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-blind sham controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Active Biofeedback | Experimental | Behavioral: Active BiofeedbackThe patients in the active group will receive one active biofeedback training session. |
| Sham Biofeedback | Sham comparator | Behavioral: Sham BiofeedbackThe patients in the sham group will receive one sham biofeedback training session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18-65 years;
- Meets DSM-5 criteria for major depressive disorder (MDD) as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI); with a current major depressive episode.
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
- Male or female aged 18-65 years;
- Does not meet for any current or past psychiatric diagnoses as defined by DSM-5 criteria as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
Key exclusion criteria (8 listed)
- Current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients and for healthy control subjects: any current or lifetime psychiatric disorder as determined by the Structured Clinical Interview for DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI);
- Active substance use disorder within the past 6 months;
- Concomitant use of any medication with central nervous system activity within 1 week of scan;
- Positive urine toxicology screen for drugs of abuse at the time of screening;
- Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;
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 |
|---|---|---|
| Active BiofeedbackThe active biofeedback session will be done within the 7T MRI. It will include a pre-training run, 3 training runs, and a post-training run. Each run will be comprised of MOTIVATE and REST trials. During each MOTIVATE trial, subjects will be instructed to "generate a heightened state of motivation". Participants will be encouraged to identify strategies that are personally relevant or useful and to monitor the efficacy of the strategies. Subjects will simultaneously view a progress bar on the screen during MOTIVATE trials that represents their VTA activity and they will be trained to try to increase the level of the bar by motivating themselves. For the active VTA biofeedback group, the progress bar will be updated every second to accurately convey level of VTA signal activation. During REST trials, all subjects will be instructed to count backwards. During the post-training 'test' run, subjects will be instructed to use the strategies they found to be most effective. | Behavioural | Active Biofeedback |
| Sham BiofeedbackThe sham biofeedback session resembles the active condition, however, the thermometer seen during the MOTIVATE trials will represent yoked sham values. | Behavioural | Sham Biofeedback |
Primary outcome
Percent Increase in VTA Activation during MOTIVATE trials
Time frame: baseline (Pre-training) and 2 hours (Post-training) during the assessment visit
For each subject, the % increase in VTA activation during MOTIVATE trails at post-training compared to pre-training will be computed ([MOTIVATEpost>RESTpost] > [MOTIVATEpre>RESTpre]), indicating the efficacy of training on VTA activity self- regulation. This measure of VTA activity self-regulation from pre to post training will be entered into an independent samples t-test to compare between active and control feedback groups.
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 4 Sep 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.
Laurel Morris, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Biofeedback in people with Major Depressive Disorder, run by Icahn School of Medicine at Mount Sinai 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 6 inclusion and 8 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 4 Sep 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. Some participants in this study may receive a placebo. 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?
Percent Increase in VTA Activation during MOTIVATE trials (time frame: baseline (Pre-training) and 2 hours (Post-training) during the assessment visit). 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 4 Sep 2024.