Neurofeedback for Depression
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: GrayMatters Health Ltd.
Must be taking: Antidepressants
Must not be taking: Benzodiazepines, Psychotropics, others
Disqualifiers: Schizophrenia, Bipolar, Substance use, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this interventional double-blind study is to demonstrate the safety and efficacy of PRISM neurofeedback training within an MDD Anhedonia sample.
The goals of this study include:
1. Demonstrating the safety and efficacy of Prism Neurofeedback training within an MDD Anhedonia sample;
2. Identifying clinical profile/symptoms-based biomarkers (e.g., Hamilton Depression Rating Scale - HDRS-21, Dimensional Anhedonia Rating Scale - DARS, Snaith-Hamilton Pleasure Scale for Clinicians SHAPS) scores that can be used by clinics to administer Prism therapy in conjunction with standard of care (SOC) therapy;
3. Producing initial guidelines for integrating Prism neurofeedback training for MDD therapy with MDD Anhedonia (SOC).
Participants will be randomly assigned to one of two arms, Active, or Sham.
Do I have to stop taking my current medications for the trial?
Participants may need to stop taking certain medications, such as benzodiazepines, which require a 2-week washout period (time without taking the medication) before starting the trial. However, stable doses of antidepressants like SSRIs, SNRIs, and bupropion are allowed. It's important not to change or start new psychiatric medications during the study.
What data supports the effectiveness of the treatment PRISM Neurofeedback Training for depression?
Research shows that neurofeedback, a type of brain training, can help reduce symptoms of depression. Studies have found that neurofeedback can lead to improvements in mood and cognitive function, and it is considered a promising supplementary treatment for depression, especially for those who do not respond well to traditional therapies.
12345Is neurofeedback generally safe for humans?
The safety of neurofeedback treatment has not been thoroughly investigated in youth or adults, but clinical experience suggests it is reasonably safe.
56789How is PRISM Neurofeedback Training different from other treatments for depression?
PRISM Neurofeedback Training is unique because it is a non-invasive treatment that uses brain activity feedback to help improve symptoms of depression, unlike traditional treatments like medication or talk therapy. It offers minimal side effects and can be used alongside standard treatments for those who do not fully respond to medication.
123410Eligibility Criteria
This trial is for adults aged 22-65 with Major Depressive Disorder (MDD) and Anhedonia, who can complete questionnaires in English and adhere to the study schedule. Participants must have specific scores on depression scales and be right-handed. Exclusions include certain mental health disorders, recent substance abuse, unstable medical conditions, use of excluded medications including benzodiazepines or dopamine-affecting drugs, recent psychotherapy initiation, pregnancy, MRI contraindications like metal implants or claustrophobia.Inclusion Criteria
You are right-handed according to Chapman and Chapman's method from 1987.
My vision and hearing are normal, or corrected to be normal.
I have been diagnosed with major depression and experience a lack of pleasure in most activities.
+6 more
Exclusion Criteria
Your hairstyle makes it difficult to place the EEG net, such as braids, dreadlocks, cornrows, or recently dyed hair.
I haven't changed or started any SSRIs or SNRIs in the last 4 weeks and don't plan to change my depression treatment during the study.
I cannot stop or switch my Benzodiazepine medication for the study.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline Assessment
Participants complete clinical assessments using questionnaires, an MRI scan, and tasks that probe reward responsivity, learning, and motivation
1 week
1 visit (in-person)
Neurofeedback Training
Participants perform at least 10 sessions but optimally 15 (+/-3) neurofeedback training sessions, performed twice a week on nonconsecutive days
5-8 weeks
10-15 visits (in-person)
Post-Treatment Assessment
Participants complete the same clinical assessments, post-NF training MRI scan, and tasks as in the baseline stage
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Participant Groups
The PRISM neurofeedback training study tests if this therapy can reduce symptoms of MDD with Anhedonia when added to standard care. It's a double-blind trial where participants are randomly assigned to receive either active neurofeedback or a sham (placebo) version over approximately two months while undergoing clinical assessments and MRIs before and after the sessions.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active ArmExperimental Treatment1 Intervention
Subjects randomized into the Active arm will receive RS-EFP-NF Prism training as an adjunct to standard of care.
Group II: Control ArmPlacebo Group1 Intervention
Subjects randomized into the Control arm will receive a Sham-EFP-NF training with the same schedule as the active arm, adjunct to standard of care.
PRISM Neurofeedback Training is already approved in United States for the following indications:
🇺🇸 Approved in United States as PRISM Neurofeedback Training for:
- Posttraumatic Stress Disorder (PTSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
McLean HospitalBelmont, MA
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Who Is Running the Clinical Trial?
GrayMatters Health Ltd.Lead Sponsor
References
Real-time fMRI neurofeedback compared to cognitive behavioral therapy in a pilot study for the treatment of mild and moderate depression. [2023]Real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback was found to reduce depressive symptoms. However, no direct comparison of drug-free patients with an active psychotherapy control group is available. The present study compared rt-fMRI neurofeedback with cognitive behavioral therapy, as the standard treatment in patients declining anti-depressants. Twenty adult, drug-free patients with mild or moderate depression were non-randomly assigned either to a course of eight half-hour sessions of neurofeedback targeting the left medial prefrontal cortex (N = 12) or to a 16-session course of cognitive behavioral therapy (N = 8). Montgomery-Asberg Depression Rating Scale was introduced at baseline, mid-treatment, and end-treatment points. In each group, 8 patients each remained in the study to a mid-treatment evaluation and 6 patients each to the study end-point. ANOVA revealed a depression reduction with a significant effect of Time (F(3,6) = 19.0, p < 0.001, η2 = 0.76). A trend to greater improvement in the cognitive behavioral therapy group compared to neurofeedback emerged (Group × Time; p = 0.078). Percent signal change in the region of interest between up- and down-regulation conditions was significantly correlated with session number (Pearson's r = 0.85, p < 0.001) indicating a learning effect. As limitations, small sample size could lead to insufficient power and non-random allocation to selection bias. Both neurofeedback and cognitive behavioral therapy improved mild and moderate depression. Neurofeedback was not superior to cognitive behavioral therapy. Noteworthy, the neurofeedback training course was associated with continuous improvement in the self-regulation skill, without plateau. This study delivers data to plan clinical trials comparing neurofeedback with cognitive behavioral interventions.
[The usage of neurofeedback in children with ADHD: the method and its evaluation]. [2019]Neurofeedback is a computer-based behavior training, which is gaining increasing interest in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). This article gives an introduction to neurofeedback and summarizes the state of research, discussing inter alia methodical aspects (e. g., requirements to a control training). Evaluation studies conducted so far indicate clinical efficacy. For example, neurofeedback training was superior to a computerized attention training in a randomized controlled trial (medium effect size). Follow-up investigations suggest that treatment effects remain stable (at least six months). At the clinical level, comparable improvements could be obtained for the neurofeedback protocols theta/beta training and training of slow cortical potentials. Neurophysiological findings document different mechanisms of theta/beta training and slow cortical potential training. Future studies should further elucidate the specificity of training effects related to the kind of training and certain disorders and address how to optimize and individualize neurofeedback training.
The Current Evidence Levels for Biofeedback and Neurofeedback Interventions in Treating Depression: A Narrative Review. [2021]This article is aimed at showing the current level of evidence for the usage of biofeedback and neurofeedback to treat depression along with a detailed review of the studies in the field and a discussion of rationale for utilizing each protocol. La Vaque et al. criteria endorsed by the Association for Applied Psychophysiology and Biofeedback and International Society for Neuroregulation & Research were accepted as a means of study evaluation. Heart rate variability (HRV) biofeedback was found to be moderately supportable as a treatment of MDD while outcome measure was a subjective questionnaire like Beck Depression Inventory (level 3/5, "probably efficacious"). Electroencephalographic (EEG) neurofeedback protocols, namely, alpha-theta, alpha, and sensorimotor rhythm upregulation, all qualify for level 2/5, "possibly efficacious." Frontal alpha asymmetry protocol also received limited evidence of effect in depression (level 2/5, "possibly efficacious"). Finally, the two most influential real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback protocols targeting the amygdala and the frontal cortices both demonstrate some effectiveness, though lack replications (level 2/5, "possibly efficacious"). Thus, neurofeedback specifically targeting depression is moderately supported by existing studies (all fit level 2/5, "possibly efficacious"). The greatest complication preventing certain protocols from reaching higher evidence levels is a relatively high number of uncontrolled studies and an absence of accurate replications arising from the heterogeneity in protocol details, course lengths, measures of improvement, control conditions, and sample characteristics.
Review of EEG-based neurofeedback as a therapeutic intervention to treat depression. [2023]Depression, or major depressive disorder, is a common mental disorder that affects individuals' behavior, mood, and physical health, and its prevalence has increased during the lockdowns implemented to curb the COVID-19 pandemic. There is an urgent need to update the treatment recommendations for mental disorders during such crises. Conventional interventions to treat depression include long-term pharmacotherapy and cognitive behavioral therapy. Electroencephalogram-neurofeedback (EEG-NF) training has been suggested as a non-invasive option to treat depression with minimal side effects. In this systematic review, we summarize the recent literature on EEG-NF training for treating depression. The 12 studies included in our final sample reported that despite several issues related to EEG-NF practices, patients with depression showed significant cognitive, clinical, and neural improvements following EEG-NF training. Given its low cost and the low risk of side effects due to its non-invasive nature, we suggest that EEG-NF is worth exploring as an augmented tool for patients who already receive standard medications but remain symptomatic, and that EEG-NF training may be an effective intervention tool that can be utilized as a supplementary treatment for depression. We conclude by providing some suggestions related to experimental designs and standards to improve current EEG-NF training practices for treating depression.
Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]Neurofeedback is a machine-mediated noninvasive treatment modality based on the analysis and "feeding back" of electroencephalogram brainwaves, which has shown efficacy with a variety of central nervous system-based problems. It has special application where patients have adverse reaction to psychopharmacologic treatments and psychotherapy, cognitive behavioral therapy, and dialectical behavior therapy have proved ineffective. Treatment modalities include active forms based on operant conditioning, involving a subject's response to stimuli. Neurofeedback is strong in clinical confirmations of efficacy (case studies) and has thus far limited controlled studies in the peer-reviewed journals.
Neurofeedback training in major depressive disorder: A systematic review of clinical efficacy, study quality and reporting practices. [2021]Major depressive disorder (MDD) is the leading cause of disability worldwide. Neurofeedback training has been suggested as a potential additional treatment option for MDD patients not reaching remission from standard care (i.e., psychopharmacology and psychotherapy). Here we systematically reviewed neurofeedback studies employing electroencephalography, or functional magnetic resonance-based protocols in depressive patients. Of 585 initially screened studies, 24 were included in our final sample (N = 480 patients in experimental and N = 194 in the control groups completing the primary endpoint). We evaluated the clinical efficacy across studies and attempted to group studies according to the control condition categories currently used in the field that affect clinical outcomes in group comparisons. In most studies, MDD patients showed symptom improvement superior to the control group(s). However, most articles did not comply with the most stringent study quality and reporting practices. We conclude with recommendations on best practices for experimental designs and reporting standards for neurofeedback training.
Real-time fMRI data for testing OpenNFT functionality. [2020]Here, we briefly describe the real-time fMRI data that is provided for testing the functionality of the open-source Python/Matlab framework for neurofeedback, termed Open NeuroFeedback Training (OpenNFT, Koush et al. [1]). The data set contains real-time fMRI runs from three anonymized participants (i.e., one neurofeedback run per participant), their structural scans and pre-selected ROIs/masks/weights. The data allows for simulating the neurofeedback experiment without an MR scanner, exploring the software functionality, and measuring data processing times on the local hardware. In accordance with the descriptions in our main article, we provide data of (1) periodically displayed (intermittent) activation-based feedback; (2) intermittent effective connectivity feedback, based on dynamic causal modeling (DCM) estimations; and (3) continuous classification-based feedback based on support-vector-machine (SVM) estimations. The data is available on our public GitHub repository: https://github.com/OpenNFT/OpenNFT_Demo/releases.
Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy. [2019]Neurofeedback (NF) using surface electroencephalographic signals has been used to treat various child psychiatric disorders by providing patients with video/audio information about their brain's electrical activity in real-time. Research data are reviewed and clinical recommendations are made regarding NF treatment of youth with attention deficit/hyperactivity disorder, autism, learning disorders, and epilepsy. Most NF studies are limited by methodological issues, such as failure to use or test the validity of a full-blind or sham NF. The safety of NF treatment has not been thoroughly investigated in youth or adults, although clinical experience suggests reasonable safety.
Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. [2023]The right inferior frontal gyrus (rIFG) is a region involved in the neural underpinning of cognitive control across several domains such as inhibitory control and attentional allocation process. Therefore, it constitutes a desirable neural target for brain-guided interventions such as neurofeedback (NF). To date, rIFG-NF has shown beneficial ability to rehabilitate or enhance cognitive functions using functional Magnetic Resonance Imaging (fMRI-NF). However, the utilization of fMRI-NF for clinical purposes is severely limited, due to its poor scalability. The present study aimed to overcome the limited applicability of fMRI-NF by developing and validating an EEG model of fMRI-defined rIFG activity (hereby termed "Electrical FingerPrint of rIFG"; rIFG-EFP). To validate the computational model, we employed two experiments in healthy individuals. The first study (n = 14) aimed to test the target engagement of the model by employing rIFG-EFP-NF training while simultaneously acquiring fMRI. The second study (n = 41) aimed to test the functional outcome of two sessions of rIFG-EFP-NF using a risk preference task (known to depict cognitive control processes), employed before and after the training. Results from the first study demonstrated neural target engagement as expected, showing associated rIFG-BOLD signal changing during simultaneous rIFG-EFP-NF training. Target anatomical specificity was verified by showing a more precise prediction of the rIFG-BOLD by the rIFG-EFP model compared to other EFP models. Results of the second study suggested that successful learning to up-regulate the rIFG-EFP signal through NF can reduce one's tendency for risk taking, indicating improved cognitive control after two sessions of rIFG-EFP-NF. Overall, our results confirm the validity of a scalable NF method for targeting rIFG activity by using an EEG probe.
A controlled study on the cognitive effect of alpha neurofeedback training in patients with major depressive disorder. [2022]Cognitive deficits are core symptoms of depression. This study aims to investigate whether neurofeedback (NF) training can improve working memory (WM) performance in patients with major depressive disorder (MDD). The NF group (n = 40) underwent eight NF sessions and was compared to a non-interventional control group (n = 20). The NF protocol aimed to increase the individual upper alpha power in the parieto-occipital area of the scalp. Main cognitive variable was WM, which was measured pre- and post- training along with other variables such as attention and executive functions. EEG was recorded in both eyes closed resting state and eyes open task-related activity, pre- and post- NF training, and pre- and post- the NF trials within each session. A power EEG analysis and an alpha asymmetry analysis were conducted at the sensor level. Frequency domain standardized low resolution tomography (sLORETA) was used to assess the effect at brain source level. Correlation analysis between the clinical/cognitive and EEG measurements was conducted at both the sensor and brain source level. The NF group showed increased performance as well as improved processing speed in a WM test after the training. The NF group showed pre-post enhancement in the upper alpha power after the training, better visible in task-related activity as compared to resting state. A current density increase appeared in the alpha band (8-12 Hz) for the NF group, localized in the subgenual anterior cingulate cortex (sgACC, BA 25). A positive correlation was found for the NF group between the improvement in processing speed and the increase of beta power at both the sensor and brain source level. These results show the effectiveness of this NF protocol in improving WM performance in patients with MDD.