Neurophysiological Interventions for Bipolar Disorder
(BandR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how technology such as neurofeedback and biofeedback—techniques providing real-time feedback on brain and body activity—can help manage mood swings in people with bipolar disorder. The researchers aim to determine if participants can recreate their recorded brain and body states from one day to another using various feedback and stimulation techniques. The trial seeks adults who experience mood swings lasting at least two days at a time. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mood management techniques for bipolar disorder.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on medications that lower the seizure threshold, you may be excluded from participating.
What prior data suggests that neuro/biofeedback is safe for neurophysiological interventions?
Research has shown that neurofeedback and biofeedback treatments are generally well-tolerated for mood disorders. Recent studies reported only a few side effects, suggesting that neurofeedback might be safe and helpful for individuals with mood issues, including bipolar disorder.
However, some studies have mentioned possible side effects, such as mild headaches or fatigue. Overall, these effects appear rare and not serious. Additionally, neurofeedback is already used for other conditions, which provides some confidence in its safety.
In summary, while minor side effects might occur, research largely considers neurofeedback treatments safe.12345Why are researchers excited about this trial?
Researchers are excited about using neuro/biofeedback for treating bipolar disorder because it offers a personalized approach that goes beyond traditional medication and therapy. Unlike standard treatments that often focus on chemical imbalances, this method aims to restore specific neurophysiological features like brain state, facial muscle activity, and heart rate variability. By using technologies such as transcranial alternating current stimulation (TACS), electromyography (EMG), and vibroacoustic stimulation, this approach encourages patients to actively engage with their own biofeedback. This could lead to more precise, individualized treatment, potentially improving outcomes and understanding of bipolar disorder.
What evidence suggests that neuro/biofeedback is effective for bipolar disorder?
Studies have shown that neurofeedback, a technique that helps individuals learn to control their brain activity, may benefit those with bipolar disorder. Research suggests that neurofeedback can help balance brain activity and improve emotional responses, which are crucial for managing bipolar disorder. Some studies indicate that when combined with therapies like cognitive behavioral therapy (CBT) or mindfulness, neurofeedback can improve mood-related symptoms. However, experts note that results have been mixed, necessitating further research to confirm these effects. Despite this, neurofeedback remains a promising method for potentially enhancing mood stability in people with bipolar disorder. Participants in this trial will receive a combination of recall, stimulation, and neurofeedback to further explore its effectiveness.26789
Who Is on the Research Team?
Greg Siegle
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with bipolar disorder who experience mood swings lasting at least two days. Participants must not have psychotic episodes, substance abuse issues (except nicotine or caffeine), metal implants near the brain, severe heart conditions, or a history of seizures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Assessment 1
Participants undergo initial assessment on a 'good' day with mood rating above 7/10
Assessment 2
Participants undergo second assessment on a 'bad' day with mood rating below 3/10
Assessment 3
Participants undergo third assessment within a week of the second session to restore brain state
Follow-up
Participants are monitored for changes in EEG activity and happiness ratings
What Are the Treatments Tested in This Trial?
Interventions
- Neuro/biofeedback
Trial Overview
The study tests if specific neurophysiological states can be recreated on different days using techniques like physiological stimulation, neuro/biofeedback, transcranial alternating current stimulation (tACS), and recall exercises.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will be given their subjective ratings and notes from the first session and asked to recreate how they were feeling at their first session during recall-only blocks. In addition, during neurofeedback and stimulation blocks, they will be given access to technologies for restoring neurophysiological features from the first assessment, including their 1) brain state, 2) facial muscle activity, and 3) heart rate variability. They will be provided with this information and asked to match their previous recordings during the neurofeedback blocks, and stimulated using Transcranial alternating current stimulation (TACS), electromyography (EMG), and vibroacoustic stimulation during the stimulation blocks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Citations
NCT05802446 | Neurofeedback for Bipolar Disorder
This study aims at assessing the efficacy of 3-weeks neurofeedback training with real-time fMRI on the treatment of residual mood symptoms in patients with BD.
Neurofeedback: A Comprehensive Review on System Design ...
Neurofeedback is a kind of biofeedback, which teaches self-control of brain functions to subjects by measuring brain waves and providing a feedback signal.
Is Biofeedback Effective for Treating Bipolar Disorder?
Neurobiofeedback has shown some promise in treating bipolar disorder, but experts say results of tests are inconclusive.
Neurofeedback Therapy For Bipolar Disorder
The efficacy of neurofeedback therapy in treating bipolar disorder is supported by its potential to stabilize brain activity and improve emotional responses.
The Combined Effectiveness of Neurofeedback and ...
NFB combined with CBT or mindfulness showed preliminary improvements in depression, anxiety, and stress (p<.05–.001). Music adjuncts showed no ...
Neurofeedback and Biofeedback for Mood and Anxiety ... - NCBI
The purpose of this review is to evaluate the more recent evidence regarding the clinical effectiveness of neurofeedback or biofeedback compared ...
A Systematic Review of the Safety and Effect ...
Despite issues with methodological quality, the overall positive findings and few reported side effects suggest neurofeedback could be helpful in alleviating ...
First, Do No Harm: Adverse Effects and the Need for ...
How- ever, it has been noted previously that side effects and adverse reactions can occur in association with neurofeedback treatment of various ...
Neuromodulation Strategies in Lifelong Bipolar Disorder
Specifically, it examines the efficacy, safety, and mechanisms of action of various neuromodulation strategies, including, among others, transcranial magnetic ...
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