Frontal Gamma Coherence Neurofeedback for Schizophrenia

FS
Overseen ByFiza Singh, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: BioSignal Solutions LLC
Must be taking: Antipsychotics

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called frontal gamma coherence neurofeedback for adults with schizophrenia. The goal is to determine if this treatment can alleviate cognitive symptoms using a special mobile platform at home. Participants will receive either the active treatment or a placebo (inactive version) to compare results. Ideal candidates are those diagnosed with schizophrenia or schizoaffective disorder who have remained stable without recent hospitalizations or medication changes.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment approach.

What prior data suggests that this neurofeedback method is safe for adults with schizophrenia?

Research has shown that frontal gamma coherence neurofeedback is generally safe and well-tolerated. Studies have examined its use for various conditions, including schizophrenia. These studies suggest that this type of neurofeedback, which trains the brain to function more effectively, usually doesn't cause serious side effects.

One review found that targeting gamma activity with neurofeedback might offer special benefits without major safety concerns. However, individual experiences can vary. Prospective trial participants should consult a healthcare provider to discuss potential risks and benefits.12345

Why are researchers excited about this trial?

Frontal Gamma Coherence Neurofeedback is unique because it offers a non-invasive method to potentially improve brain function in individuals with schizophrenia, targeting the brain's gamma waves to enhance connectivity and coherence in the frontal regions. Unlike traditional treatments like antipsychotic medications that mainly focus on reducing symptoms through chemical pathways, this technique leverages advanced neurofeedback technology to train the brain directly. Researchers are excited about this approach because it could lead to improvements in cognitive function and overall brain health without the side effects commonly associated with medications. This innovative method represents a fresh perspective on managing schizophrenia, aiming to address some underlying neurological aspects of the condition.

What evidence suggests that frontal gamma coherence neurofeedback might be an effective treatment for schizophrenia?

This trial will compare active frontal gamma coherence neurofeedback with placebo neurofeedback for schizophrenia. Research has shown that neurofeedback can improve symptoms in people with schizophrenia. By adjusting brain wave patterns, neurofeedback aims to restore balance. Studies have found that this method can enhance thinking skills and mood. Some research also indicates better brain coordination, often disrupted in schizophrenia. Although neurofeedback remains under study, early results suggest it could help manage schizophrenia symptoms.678910

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with schizophrenia or schizoaffective disorder. Participants must be able to attend in-person assessments at UC San Diego and use a mobile neurofeedback platform at home.

Inclusion Criteria

Clinically stable as ascertained to be clinically and medically stable by one of the study investigators
Clinically stable as operationalized by not having been admitted to a psychiatric hospital within the three months prior to assessment
My antipsychotic medication dose has not changed in the past four weeks.
See 3 more

Exclusion Criteria

I am currently experiencing major depression.
Medical conditions that can impact cognition, including self-reported history of seizure disorder, multiple sclerosis, stroke or major vascular disease, HIV/AIDS, brain cancer, prior head injury involving loss of consciousness
I cannot see or use a smartphone or tablet by myself.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments in person at UCSD and receive training on home use of the neurofeedback platform

1 week
1 visit (in-person)

Treatment

Participants engage in twice-weekly 30-minute neurofeedback sessions at home for 12 weeks, with midpoint and end-of-treatment assessments at UCSD

12 weeks
24 sessions (home), 2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Frontal Gamma Coherence Neurofeedback

Trial Overview

The study tests whether frontal gamma coherence neurofeedback, delivered via a mobile device, can help people with schizophrenia. Participants are randomly assigned to either real or placebo (inactive) neurofeedback sessions twice weekly for 12 weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active frontal gamma coherence neurofeedbackActive Control1 Intervention
Group II: Placebo neurofeedbackPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioSignal Solutions LLC

Lead Sponsor

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Citations

Neurofeedback Training as Adjuvant Therapy for Improving ...

This study explores the use of neurofeedback as an adjuvant therapy in a 50-year-old female patient with a history of paranoid schizophrenia.

EEG Variabilities in Diagnosis of Schizophrenia, Bipolar Disorder ...

Bridging the gap between mental health disorders, Kam et al. (2013) reviewed resting EEG power and EEG coherence between schizophrenia and bipolar disorder.

Neurofeedback in Psychiatry: A Decade of Clinical and ...

Across disorders, NF was generally associated with symptom improvements. In ADHD, randomized trials and meta-analyses report moderate improvements in ...

Volitional Control of Neuromagnetic Coherence - PMC - NIH

A vast literature has documented such changes in a variety of diseases, including schizophrenia (Uhlhaas and Singer, 2010), unipolar major depressive disorder ( ...

Clinical EEG and Neuroscience

Mismatch negativity (MMN) is a promising diagnostic biomarker for schizophrenia and bipolar disorder, but its role in predicting psychosis is ...

A Focused Review of Gamma Neuromodulation as a ...

We conclude by reviewing how electroencephalographic (EEG) neurofeedback (NFB) targeting frontal gamma activity may provide unique advantages ...

A systematic scoping review, synthesis, and future directions

Here, we conducted a scoping systematic review according to PRISMA guidelines, mapping the NF- MED field across both clinical and non- clinical ...

Treatment-resistant schizophrenia: Definition ...

Novel EEG-based neurofeedback system targeting frontal gamma activity of schizophrenia patients to improve working memory. In: 2022 44th ...

Neuroimaging Insights into the Public Health Burden of ...

Real EEG-neurofeedback training predictably increased frontal beta activity, and this increase was maintained for 3 years after the training. ...

Machine Learning and LORETA Neurofeedback at Precuneus

Abstract. Substance use disorders (SUD) remain among the most treatment-resistant conditions, particularly in incarcerated populations.