~104 spots leftby Apr 2027

Neurofeedback for Depression

Recruiting in Palo Alto (17 mi)
Overseen byKymberly Young, PhD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Kymberly Young
Must be taking: Antidepressants
Must not be taking: Antipsychotics, Anticonvulsants, Stimulants, others
Disqualifiers: Cardiovascular, Substance use, Brain injury, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as a stand-alone intervention for major depressive disorder

Will I have to stop taking my current medications?

If you are stable on an antidepressant, you can continue taking it during the study. However, if you are taking antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications that might affect brain blood flow, you may need to stop them at least 3 weeks before participating.

What data supports the effectiveness of the treatment Amygdala real-time fMRI neurofeedback for depression?

Research shows that real-time fMRI neurofeedback, which helps people learn to control their brain activity, can improve emotional control and reduce depressive symptoms by increasing positive memory recall. Studies suggest that this treatment can enhance the effectiveness of traditional therapies like cognitive behavioral therapy (CBT) for depression.12345

Is neurofeedback using real-time fMRI safe for humans?

Research on real-time fMRI neurofeedback, including studies on healthy individuals and those with depression, suggests it is generally safe. The technique involves training people to control specific brain areas, like the amygdala, and has been used without significant safety concerns in various studies.34678

How is the treatment 'Amygdala real-time fMRI neurofeedback' different from other treatments for depression?

This treatment is unique because it uses real-time brain imaging to help patients learn to control their brain activity, specifically targeting the amygdala, which is involved in emotional processing. Unlike traditional therapies, it provides immediate feedback on brain function, allowing patients to practice regulating their emotions in real-time.12348

Eligibility Criteria

This trial is for adults aged 18-55 with Major Depressive Disorder (MDD) who are either not on medication or have been stable on antidepressants for at least 4 weeks. Participants must be able to consent and complete questionnaires in English. Those with unstable health conditions, pregnant or breastfeeding women, individuals taking certain medications like antipsychotics or stimulants, and those with severe substance use disorders cannot join.

Inclusion Criteria

I have been diagnosed with major depression and am currently feeling depressed.
Able to give written informed consent prior to participation
I am between 18 and 55 years old.
See 1 more

Exclusion Criteria

I have been diagnosed with a psychotic, bipolar, or organic mental disorder.
I have eye problems or trouble seeing even with glasses or contacts.
I cannot fill out forms in English.
See 6 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two rtfMRI-nf sessions, one week apart, to increase amygdala response to positive memories

2 weeks
2 visits (in-person)

Follow-up

Participants complete the BDI-II monthly for one year following completion of the neurofeedback intervention

12 months
Monthly assessments (virtual)

Treatment Details

Interventions

  • Amygdala real-time fMRI neurofeedback (Behavioral Intervention)
  • Sham feedback (Behavioral)
Trial OverviewThe study tests if a type of brain scan feedback called rtfMRI-nf can help people by increasing the amygdala's response to positive memories as a treatment for depression. Participants will receive either actual neurofeedback or sham (fake) feedback as part of the study.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Amygdala real-time fMRI neurofeedbackExperimental Treatment1 Intervention
Amygdala neurofeedback - attempt to upregulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Two sessions will be performed one week apart.
Group II: Sham feedbackPlacebo Group1 Intervention
Yoked sham - participants will see the amygdala activity of another subject who completed the intervention. Two sessions will be performed one week apart.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?

Kymberly YoungLead Sponsor
University of PittsburghLead Sponsor
National Institute of Mental Health (NIMH)Collaborator

References

Amygdala real-time functional magnetic resonance imaging neurofeedback for major depressive disorder: A review. [2020]Advances in imaging technologies have allowed for the analysis of functional magnetic resonance imaging data in real-time (rtfMRI), leading to the development of neurofeedback (nf) training. This rtfMRI-nf training utilizes functional magnetic resonance imaging (fMRI) tomographic localization capacity to allow a person to see and regulate the localized hemodynamic signal from his or her own brain. In this review, we summarize the results of several studies that have developed and applied neurofeedback training to healthy and depressed individuals with the amygdala as the neurofeedback target and the goal to increase the hemodynamic response during positive autobiographical memory recall. We review these studies and highlight some of the challenges and advances in developing an rtfMRI-nf paradigm for broader use in psychiatric populations. The work described focuses on our line of research aiming to develop the rtfMRI-nf into an intervention, and includes a discussion of the selection of a region of interest for feedback, selecting a control condition, behavioral and cognitive effects of training, and predicting which participants are most likely to respond well to training. While the results of these studies are encouraging and suggest the clinical potential of amygdala rtfMRI-nf in alleviating symptoms of major depressive disorder, larger studies are warranted to confirm its efficacy.
Real-Time Functional Magnetic Resonance Imaging Amygdala Neurofeedback Changes Positive Information Processing in Major Depressive Disorder. [2019]In participants with major depressive disorder who are trained to upregulate their amygdalar hemodynamic responses during positive autobiographical memory recall with real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training, depressive symptoms diminish. This study tested whether amygdalar rtfMRI-nf also changes emotional processing of positive and negative stimuli in a variety of behavioral and imaging tasks.
Connectivity based Real-Time fMRI Neurofeedback Training in Youth with a History of Major Depressive Disorder. [2023]Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) has proven to be a powerful technique to help subjects to gauge and enhance emotional control. Traditionally, rtfMRI-nf has focused on emotional regulation through self-regulation of amygdala. Recently, rtfMRI studies have observed that regulation of a target brain region is accompanied by connectivity changes beyond the target region. Therefore, the aim of present study is to investigate the use of connectivity between amygdala and prefrontal regions as the target of neurofeedback training in healthy individuals and subjects with a life-time history of major depressive disorder (MDD) performing an emotion regulation task.
Enhanced efficacy of CBT following augmentation with amygdala rtfMRI neurofeedback in depression. [2023]Despite cognitive behavioral therapy (CBT) being a standard treatment in major depressive disorder (MDD), nearly half of patients do not respond. As one of the predictors of CBT's efficacy is amygdala reactivity to positive information, which is often decreased in MDD, we explored whether real-time fMRI neurofeedback (rtfMRI-nf) training to increase amygdala responses during positive memory recall prior CBT would enhance its efficacy.
Self-regulation of amygdala activation using real-time FMRI neurofeedback. [2021]Real-time functional magnetic resonance imaging (rtfMRI) with neurofeedback allows investigation of human brain neuroplastic changes that arise as subjects learn to modulate neurophysiological function using real-time feedback regarding their own hemodynamic responses to stimuli. We investigated the feasibility of training healthy humans to self-regulate the hemodynamic activity of the amygdala, which plays major roles in emotional processing. Participants in the experimental group were provided with ongoing information about the blood oxygen level dependent (BOLD) activity in the left amygdala (LA) and were instructed to raise the BOLD rtfMRI signal by contemplating positive autobiographical memories. A control group was assigned the same task but was instead provided with sham feedback from the left horizontal segment of the intraparietal sulcus (HIPS) region. In the LA, we found a significant BOLD signal increase due to rtfMRI neurofeedback training in the experimental group versus the control group. This effect persisted during the Transfer run without neurofeedback. For the individual subjects in the experimental group the training effect on the LA BOLD activity correlated inversely with scores on the Difficulty Identifying Feelings subscale of the Toronto Alexithymia Scale. The whole brain data analysis revealed significant differences for Happy Memories versus Rest condition between the experimental and control groups. Functional connectivity analysis of the amygdala network revealed significant widespread correlations in a fronto-temporo-limbic network. Additionally, we identified six regions--right medial frontal polar cortex, bilateral dorsomedial prefrontal cortex, left anterior cingulate cortex, and bilateral superior frontal gyrus--where the functional connectivity with the LA increased significantly across the rtfMRI neurofeedback runs and the Transfer run. The findings demonstrate that healthy subjects can learn to regulate their amygdala activation using rtfMRI neurofeedback, suggesting possible applications of rtfMRI neurofeedback training in the treatment of patients with neuropsychiatric disorders.
Real-time neurofeedback using functional MRI could improve down-regulation of amygdala activity during emotional stimulation: a proof-of-concept study. [2021]The amygdala is a central target of emotion regulation. It is overactive and dysregulated in affective and anxiety disorders and amygdala activity normalizes with successful therapy of the symptoms. However, a considerable percentage of patients do not reach remission within acceptable duration of treatment. The amygdala could therefore represent a promising target for real-time functional magnetic resonance imaging (rtfMRI) neurofeedback. rtfMRI neurofeedback directly improves the voluntary regulation of localized brain activity. At present, most rtfMRI neurofeedback studies have trained participants to increase activity of a target, i.e. up-regulation. However, in the case of the amygdala, down-regulation is supposedly more clinically relevant. Therefore, we developed a task that trained participants to down-regulate activity of the right amygdala while being confronted with amygdala stimulation, i.e. negative emotional faces. The activity in the functionally-defined region was used as online visual feedback in six healthy subjects instructed to minimize this signal using reality checking as emotion regulation strategy. Over a period of four training sessions, participants significantly increased down-regulation of the right amygdala compared to a passive viewing condition to control for habilitation effects. This result supports the concept of using rtfMRI neurofeedback training to control brain activity during relevant stimulation, specifically in the case of emotion, and has implications towards clinical treatment of emotional disorders.
fMRI neurofeedback of amygdala response to aversive stimuli enhances prefrontal-limbic brain connectivity. [2017]Down-regulation of the amygdala with real-time fMRI neurofeedback (rtfMRI NF) potentially allows targeting brain circuits of emotion processing and may involve prefrontal-limbic networks underlying effective emotion regulation. Little research has been dedicated to the effect of rtfMRI NF on the functional connectivity of the amygdala and connectivity patterns in amygdala down-regulation with neurofeedback have not been addressed yet. Using psychophysiological interaction analysis of fMRI data, we present evidence that voluntary amygdala down-regulation by rtfMRI NF while viewing aversive pictures was associated with increased connectivity of the right amygdala with the ventromedial prefrontal cortex (vmPFC) in healthy subjects (N=16). In contrast, a control group (N=16) receiving sham feedback did not alter amygdala connectivity (Group×Condition t-contrast: p
Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. [2021]Real-time functional magnetic resonance imaging-based neurofeedback (rt-fMRI NF) is a recent technique used to train self-regulation of circumscribed brain areas or networks. For clinical applications in depression, NF training targets brain areas with disturbed activation patterns, such as heightened reactivity of amygdala in response to negative stimuli, in order to normalize the neurophysiology and their behavioral correlates. Recent studies have targeted emotion processing areas such as the amygdala, the salience network, and top-down control areas such as the lateral prefrontal cortex. Different methods of rt-fMRI-based NF in depression, their potential for clinical improvement, and most recent advancements of this technology are discussed considering their role for future clinical applications. Initial findings of randomized controlled trials show promising results. However, for lasting treatment effects, clinical efficiency and optimal target regions, tasks, control conditions, and duration of training need to be established.