100 Participants Needed

Amygdala Neurofeedback for Depression

KY
SB
Overseen ByScott Barb
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Kymberly Young
Must be taking: SSRI antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

You can continue taking your current SSRI antidepressant if it's stable for at least 3 weeks. However, you must stop taking any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications that might affect brain blood flow at least 3 weeks before the trial.

What data supports the effectiveness of the treatment Amygdala Neurofeedback for Depression?

Research shows that Amygdala Neurofeedback, which involves training the brain to respond more positively using real-time brain imaging, can help reduce symptoms of depression. Studies found that this treatment can improve emotional processing and increase brain connectivity, leading to better mood regulation in people with depression.12345

Is Amygdala Neurofeedback safe for humans?

Research on real-time functional MRI neurofeedback (rtfMRI-NF) involving the amygdala has been conducted with healthy participants and those with a history of depression, showing that it can help regulate brain activity without reported safety issues. These studies suggest that the technique is generally safe for human use.13678

How is Amygdala Neurofeedback treatment different from other treatments for depression?

Amygdala Neurofeedback is unique because it uses real-time brain imaging to help individuals learn to control their brain activity, specifically targeting the amygdala, which is involved in emotional processing. This approach is different from traditional treatments like medication or talk therapy, as it directly trains the brain to improve emotional regulation and processing of positive information.123910

What is the purpose of this trial?

The purpose of this study is to determine the clinical efficacy of real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to increase the amygdala's response to positive autobiographical memories in patients with depression who are considered treatment-resistant

Research Team

KY

Kymberly Young, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for right-handed adults aged 18-55 with Major Depressive Disorder (MDD) who haven't improved after two SSRI treatments. Participants can be unmedicated or on a stable SSRI regimen, must experience anhedonia, and have difficulty recalling specific positive memories. Exclusions include other major psychiatric disorders, recent substance dependence, traumatic brain injury, MRI incompatibility (like claustrophobia), pregnancy, breastfeeding, non-English speakers, vision issues without correction, and certain unstable medical conditions.

Inclusion Criteria

must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test
I have tried two SSRI medications without success.
I am not on antidepressants or have been stable on SSRI antidepressants for at least 3 weeks.
See 2 more

Exclusion Criteria

are unable to complete questionnaires written in English
You cannot have an MRI scan due to feeling very uncomfortable in small or enclosed spaces (claustrophobia) or having certain metal objects inside your body.
I do not have any serious or unstable health conditions.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 sessions of real-time fMRI neurofeedback training over a 2-month period

8 weeks

Follow-up

Participants are monitored for changes in amygdala activity and clinical symptoms after treatment

4 weeks

Treatment Details

Interventions

  • Amygdala Neurofeedback
  • Parietal Neurofeedback
Trial Overview The study tests if neurofeedback using real-time fMRI can help patients with treatment-resistant depression by enhancing the amygdala's response to positive memories. It involves two types of neurofeedback: one targeting the parietal region and another focusing on the amygdala of the brain.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Amygdala NeurofeedbackExperimental Treatment1 Intervention
attempt to up regulate the left amygdala during positive autobiographical memory recall via real time fMRI neurofeedback from the amygdala. Five sessions will be performed within a 2 month period.
Group II: Parietal NeurofeedbackActive Control1 Intervention
attempt to upregulate the left horizontal segment of the intraparietal sulcus, a region not involved in emotional processing, during positive autobiographical memory recall via real time fMRI neurofeedback. Five sessions will be performed within a 2 month period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kymberly Young

Lead Sponsor

Trials
4
Recruited
440+

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

In a study involving 35 adults with major depressive disorder, real-time fMRI neurofeedback (rtfMRI-nf) training to enhance amygdala responses during positive memory recall led to significant reductions in depressive symptoms and higher remission rates at 6 months and 1 year follow-up compared to a control group.
The combination of rtfMRI-nf and cognitive behavioral therapy (CBT) encouraged participants to focus more on positive thoughts and behaviors, suggesting that this approach may enhance the effectiveness of standard CBT in treating depression.
Enhanced efficacy of CBT following augmentation with amygdala rtfMRI neurofeedback in depression.Compère, L., Siegle, GJ., Riley, E., et al.[2023]
Training patients with major depressive disorder to enhance their amygdalar responses to positive memories using real-time fMRI neurofeedback led to increased amygdalar activity when viewing happy faces and decreased activity for sad faces, indicating a shift in emotional processing.
The training also improved participants' ability to identify positive emotional stimuli and reduced their reaction times to positive faces, suggesting that this neurofeedback approach may have effects similar to those of antidepressant medications.
Real-Time Functional Magnetic Resonance Imaging Amygdala Neurofeedback Changes Positive Information Processing in Major Depressive Disorder.Young, KD., Misaki, M., Harmer, CJ., et al.[2019]
In a study involving 10 individuals with a history of major depressive disorder (MDD) and 12 healthy controls, real-time fMRI neurofeedback (rtfMRI-nf) targeting the connectivity between the amygdala and prefrontal regions showed potential for enhancing emotional regulation, particularly in healthy individuals who exhibited increased frontal cortex activation during training.
Participants with a history of MDD demonstrated a trend towards decreased functional connectivity over the training runs, and while the overall group experienced a reduction in negative emotions, the MDD group specifically showed a significant decrease in positive emotions after the neurofeedback sessions.
Connectivity based Real-Time fMRI Neurofeedback Training in Youth with a History of Major Depressive Disorder.He, X., Moreno, DR., Hou, Z., et al.[2023]

References

Enhanced efficacy of CBT following augmentation with amygdala rtfMRI neurofeedback in depression. [2023]
Real-Time Functional Magnetic Resonance Imaging Amygdala Neurofeedback Changes Positive Information Processing in Major Depressive Disorder. [2019]
Connectivity based Real-Time fMRI Neurofeedback Training in Youth with a History of Major Depressive Disorder. [2023]
Self-regulation of amygdala activation using real-time FMRI neurofeedback. [2021]
Resting-state functional connectivity modulation and sustained changes after real-time functional magnetic resonance imaging neurofeedback training in depression. [2022]
Real-time neurofeedback using functional MRI could improve down-regulation of amygdala activity during emotional stimulation: a proof-of-concept study. [2021]
Down-regulation of amygdala activation with real-time fMRI neurofeedback in a healthy female sample. [2021]
fMRI neurofeedback of amygdala response to aversive stimuli enhances prefrontal-limbic brain connectivity. [2017]
Amygdala real-time functional magnetic resonance imaging neurofeedback for major depressive disorder: A review. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Clinical Application of Real-Time fMRI-Based Neurofeedback for Depression. [2021]
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