Neurofeedback for Schizophrenia

Overseen By Fiza Singh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Substance use, Brain injury, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you haven't changed medications in the last 30 days. This suggests you should stay on your current medication without changes.

What data supports the effectiveness of the treatment Neurofeedback for Schizophrenia?

Research suggests that neurofeedback, a technique that helps people learn to control their brain activity, may lead to changes in brain function and improve symptoms in schizophrenia. A case report showed that Infra-Low Frequency Neurofeedback had dramatic effects on reducing psychotic symptoms and anxiety in a patient with schizophrenia. Additionally, a study found that patients who showed a specific learning pattern during neurofeedback training experienced improvements in auditory verbal hallucinations. ^{1 2 3 4 5}

Is neurofeedback safe for humans?

Neurofeedback, including types like EEG and fMRI neurofeedback, has been used in studies with healthy individuals and those with conditions like schizophrenia, showing no major safety concerns reported in these studies. ^{2 5 6 7 8}

How is Neurofeedback treatment different from other treatments for schizophrenia?

Neurofeedback is unique because it is a noninvasive treatment that helps patients learn to regulate their brain activity through real-time feedback, unlike traditional medications or therapies. It shows promise in improving cognitive symptoms and overall brain function, which are often not adequately addressed by standard treatments for schizophrenia. ^{1 2 3 8 9}

What is the purpose of this trial?

This trial tests a computer-based brain training program called Gamma Neurofeedback (G-NFB) for patients with schizophrenia. It aims to improve their memory and cognitive function by helping their brains synchronize better. If successful, it could offer a new way to treat cognitive deficits in these patients.

Eligibility Criteria

This trial is for individuals diagnosed with schizophrenia or schizoaffective disorder. It's not suitable for pregnant individuals, those who've changed medications in the last month, have a history of traumatic brain injury, active substance use disorders within the past month, or a seizure disorder.

Inclusion Criteria

I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

Active substance use disorders in the last 30 days

Pregnancy

I have a history of seizures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gamma neurofeedback training to enhance gamma band response

12 weeks

24 sessions (2 sessions per week)

Follow-up

Participants are monitored for changes in gamma band response and working memory post-treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Neurofeedback

Trial Overview The study is testing a new computer-based brain training program designed to improve working memory in patients with schizophrenia. The goal is to see if this neurofeedback intervention can lead to better outcomes and quality of life.

Participant Groups

Group I: Schizophrenia patients Experimental Treatment 1 Intervention

Thirty SCZ patients will receive neurofeedback to enhance gamma band response in an open-label, proof of concept study.

Neurofeedback is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurofeedback for:

• Chronic low back pain
• Fibromyalgia
• Neuropathic pain

Approved in European Union as Neurofeedback for:

• Chronic pain
• Fibromyalgia
• Neuropathic pain

Approved in Canada as Neurofeedback for:

• Chronic pain
• Fibromyalgia

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The study developed a new EEG-based neurofeedback method targeting the right inferior frontal gyrus (rIFG), which showed successful engagement of the intended brain region during training, as confirmed by fMRI results from a small group of 14 participants.

After two sessions of this EEG neurofeedback training with 41 participants, individuals demonstrated improved cognitive control by reducing their risk-taking behavior, indicating the method's potential efficacy for enhancing cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. Or-Borichev, A., Gurevitch, G., Klovatch, I., et al.[2023]

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Potential Use of Neurofeedback in Patients With Schizophrenia. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Infra-Low Frequency Neurofeedback rapidly ameliorates schizophrenia symptoms: A case report of the first session. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Improving Clinical, Cognitive, and Psychosocial Dysfunctions in Patients with Schizophrenia: A Neurofeedback Randomized Control Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback-Based Enhancement of Single-Trial Auditory Evoked Potentials: Treatment of Auditory Verbal Hallucinations in Schizophrenia. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Recent findings on neurofeedback training for auditory hallucinations in schizophrenia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

FRIEND Engine Framework: a real time neurofeedback client-server system for neuroimaging studies. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Neurofeedback: One of today's techniques in psychiatry? [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]