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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain training method using neurofeedback (also known as EEG Biofeedback, fMRI Biofeedback, Infraslow Neurofeedback, ISF Neurofeedback, or sLORETA Neurofeedback) to help people with schizophrenia improve their working memory. Schizophrenia can cause memory problems that complicate daily tasks. The trial aims for this treatment to lead to better long-term outcomes for patients. Participants should have a diagnosis of schizophrenia or schizoaffective disorder and should not have recent substance use or medication changes. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance daily life for those with schizophrenia.

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 prior data suggests that neurofeedback is safe for schizophrenia patients?

Research shows that neurofeedback, a technique that helps manage brain activity, is generally safe for treating schizophrenia. Studies have found that using neurofeedback alongside medication effectively improves symptoms in people with schizophrenia, indicating that the treatment is well-tolerated.

Most reports do not mention any serious side effects from neurofeedback. The method teaches individuals to change their brain activity using feedback from brain wave measurements. Being non-invasive, it doesn't involve surgery or entering the body, which usually means fewer risks.

Overall, current research indicates that neurofeedback is safe for treating schizophrenia. However, participants should discuss any concerns with their healthcare providers before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neurofeedback is unique because it offers a non-invasive approach to treating schizophrenia by enhancing brain activity, specifically the gamma band response. Unlike traditional antipsychotic medications, which often target neurotransmitter imbalances, neurofeedback works by training the brain to regulate its own activity through real-time feedback. This technique could potentially reduce symptoms without the side effects commonly associated with medications. Researchers are excited because neurofeedback not only offers a novel mechanism of action but also empowers patients to actively participate in their own treatment, possibly leading to improved long-term outcomes.

What evidence suggests that neurofeedback is effective for schizophrenia?

Research has shown that neurofeedback, which participants in this trial will receive, can help improve symptoms in people with schizophrenia. One study found that 47 out of 48 participants improved after receiving neurofeedback, as reflected in their PANSS scores, a tool used to measure the severity of schizophrenia symptoms. Another review found that combining neurofeedback with medication significantly improves symptoms, especially with frequent sessions over several weeks. These findings suggest that neurofeedback could be a promising approach to addressing cognitive issues like poor working memory in schizophrenia. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985524/

Systematic review and meta-analysis of the effects of EEG ... EEG-NF combined with pharmacological treatment effectively improves schizophrenia symptoms. A regimen of ≥4 sessions/week for ≥8 weeks, targeting SMR and beta ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11278179/

A Systematic Review of the Effects of EEG Neurofeedback on ... We aim to provide important evidence of neuromodulation using NF in patients with schizophrenia, summarizing the effects and conclusions found ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724000284?via%20%3Dihub

The effects of swLORETA Z-score neurofeedback for ... The swLORETA with Z-score neurofeedback (swLZNFB) was converted raw EEG data into a Z-score of CSD to present deep brain regions activities ...

4. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.923695/full

Infra-Low Frequency Neurofeedback rapidly ameliorates ... According to a review of recent meta-analyses, the acute efficacy in schizophrenia was found to be modest (Haddad and Correll, 2018) with the antipsychotic ...

5. csusb.edu csusb.edu/sites/default/files/upload/file/Schizophrenia%20and%20the%20Efficacy%20of%20NF%20-%20Turkey.pdf

Schizophrenia and the Efficacy of NF Forty-seven out of 48 schizophrenic subjects showed clinical improvement after neurofeedback treatment, based on changes in their PANSS scores. The subjects who ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4892319/

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.

7. mdpi.com mdpi.com/2075-4426/14/7/763

A Systematic Review of the Effects of EEG Neurofeedback ... We review, in a systematic way, the primary reports of electroencephalogram (EEG)-based NF as a therapeutical tool for schizophrenia.

8. academic.oup.com academic.oup.com/schizbullopen/article/1/1/sgaa005/5771249

A Systematic Review of the Potential Use of Neurofeedback in ... We used the search terms “(neurofeedback OR biofeedback)” AND schizophrenia in PubMed. This produced 95 articles published from 1964 to 2019. Of ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9790100/

Comparing LORETA Z Score Neurofeedback and Cognitive ... According to study results, LZNFB training is more effective than cognitive rehabilitation in decreasing cravings and improving the quality of life in addiction ...