CLINICAL TRIAL

rt-fMRI neurofeedback for Schizophrenia

Recruiting · 18 - 65 · All Sexes · Brockton, MA

This study is evaluating whether real-time fMRI neurofeedback can help reduce auditory hallucinations in patients with schizophrenia.

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About the trial for Schizophrenia

Eligible Conditions
Hallucinations · Schizophrenia · Superior Temporal Gyrus · visual/auditory hallucinations · Neurofeedback

Treatment Groups

This trial involves 2 different treatments. Rt-fMRI Neurofeedback is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
rt-fMRI neurofeedback
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
rt-fMRI neurofeedback
OTHER

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
a diagnosis of schizophrenia or schizoaffective disorder based on SCID interview (DSM-5)
the presence of auditory hallucinations (PANSS, item 3, score ≥4) with frequency of AH being at least once daily;
estimated IQ of above 80 as measured by WASI;
English as the primary language;
right-handed as determined by the Edinburgh Handedness Inventory (scoring + 60; Oldfield, 1971);
an ability and desire to participate in the testing program as explained by an experimenter and confirmed with a written consent form.
age between 18-55 years;
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1-2 weeks, post rt-fMRI session
Screening: ~3 weeks
Treatment: Varies
Reporting: 1-2 weeks, post rt-fMRI session
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1-2 weeks, post rt-fMRI session.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether rt-fMRI neurofeedback will improve 1 primary outcome and 1 secondary outcome in patients with Schizophrenia. Measurement will happen over the course of 1-2 weeks, post rt-fMRI session.

rt-fMRI neurofeedback from mPFC
1-2 WEEKS, POST RT-FMRI SESSION
changes in BOLD activation in mPFC
1-2 WEEKS, POST RT-FMRI SESSION
rt-fMRI neurofeedback from STG
1-2 WEEKS, POST RT-FMRI SESSION
changes in BOLD activation in STG
1-2 WEEKS, POST RT-FMRI SESSION

Who is running the study

Principal Investigator
M. N.
Prof. Margaret Niznikiewicz, associate professor; lab director
Harvard Medical School (HMS and HSDM)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can schizophrenia be cured?

The term psychopharmacological treatment or psychosocial intervention alone does not guarantee that people with schizophrenia improve their quality of life, their functioning in society or their symptoms. The current evidence does not show that psychopharmacotherapy or psychosocial interventions can significantly influence the course of schizophrenia.

Anonymous Patient Answer

What is schizophrenia?

Schizophrenia is a complex, chronic syndrome characterized in part by a persistent deterioration of brain structure and function. It is diagnosed by exclusion of alternative neuropsychiatric diagnoses; schizophrenia typically appears in early adulthood. Schizophrenic patients often experience severe cognitive symptoms. Symptoms of schizophrenia typically include hallucinations, lack of emotional responsiveness, disorganized thinking, lack of social insight, and reduced social functioning. The development of effective treatment for this syndrome will require the development of a better understanding of the pathogenesis of schizophrenia and its neurochemical, genetic, neural, and psychosocial correlates.

Anonymous Patient Answer

What are common treatments for schizophrenia?

Common treatment includes medication (anatomical classes), non-invasive brain stimulation, pharmacotherapy and psychiatric counseling. Evidence of cognitive deficits is found in the overwhelming majority of individuals with schizophrenia, however treatment is ineffective in improving these cognitive deficits.

Anonymous Patient Answer

How many people get schizophrenia a year in the United States?

Around 250,000 people in the United States are diagnosed with the schizophrenia (in most cases it is of the primary schizophrenic type) and more than 1 million people have the disorder, both as primary diagnostic diagnoses and as comorbid diagnoses. It is estimated that 2% to 10% of the US population has the disorder at any one time.

Anonymous Patient Answer

What causes schizophrenia?

For the most common psychiatric illnesses, both genetic and environmental factors appear to be important. This is probably also the case for schizophrenia; although, as yet, there has not been a single unambiguous single genetic or environmental cause for schizophrenia.

Anonymous Patient Answer

What are the signs of schizophrenia?

Signs of schizophrenia can include hallucinations of someone's voice or hands. Other noticeable changes can be hallucinations of words or objects, delusions and lack of interest in the past or future. It is also possible for schizophrenia to present without hallucinations.\n

Anonymous Patient Answer

What is the primary cause of schizophrenia?

The cause of schizophrenia is complex and is likely to change as new data become available. Current research, combined with the most recent scientific evidence, suggests that the development of schizophrenia may be a combination of genes and environmental factors. There may be an identifiable genetic component to schizophrenia. Other evidence suggests that the genetic factors may interact with environmental circumstances during a person's life to produce the clinical manifestations of schizophrenia. Evidence from epidemiologic studies (the study of the incidence, prevalence, and mortality of schizophrenia) and from the study of families with multiple cases of schizophrenia suggests that environmental factors act in concert with an identifiable genetic vulnerability to produce an abnormal development of the central nervous system of the brain that leads to the development of schizophrenia.

Anonymous Patient Answer

What is rt-fmri neurofeedback?

In this small study, rt-FMRI demonstrated clinically relevant reductions in left prefrontal cortex and insular cortex volumes in treatment responders compared to control subjects. This suggests a potential neural mechanism for rt-FMRI's antidepressant efficacy. Further, rt-FMRI demonstrates the potential utility of in vivo neurofeedback for the treatment of other brain disorders that may also benefit from brain changes.

Anonymous Patient Answer

Is rt-fmri neurofeedback safe for people?

(1) Fmri is a safe modality in healthy people;(2) Fmri does not cause hallucinations, as is common, but will induce change in baseline BOLD responses;(3) In a recent study, findings suggests that Fmri may be particularly useful when there is a comorbid anxiety disorder, such as panic disorder.

Anonymous Patient Answer

How serious can schizophrenia be?

In recent years, our understanding of schizophrenia has steadily increased. There has been a decrease in severity of the disease, but it is still the biggest challenge for the research teams to treat and manage schizophrenia. In the case of schizophrenia, there are other people who suffer from psychosis, but our knowledge about schizophrenia is insufficient in comparison. Therefore, a serious need persists to discover and develop a cure for schizophrenia. One potential target for treatment is glutamate, a neurotransmitter, and its receptors. It was shown that there is a decrease in glutamate concentration in the brains of people who suffer from schizophrenia. Some recent research also points at the gene glutamate ("GLUD1") which is located in chromosome 1.

Anonymous Patient Answer

Have there been any new discoveries for treating schizophrenia?

Drugs in the last couple of years have shown improvement in people diagnosed with schizophrenia on many of the same medications they've used for years. Specifically, some evidence has emerged for atypical antipsychotics to have greater effectiveness in treating schizophrenia than typical antipsychotics and serotonin-noradrenaline reuptake inhibitors. However, there is still no clear, definitive evidence or guideline for treating schizophrenia. The most recent treatments are mostly limited or restricted, as they are for most medical treatments. There is a lot to work as yet to be discovered in the treatment of schizophrenia.

Anonymous Patient Answer

How does rt-fmri neurofeedback work?

Significant changes were observed in the cortical glucose metabolism and blood rt-fMsr following rt-fMRI neurofeedback training. These modifications showed a correlation with neuropsychological test results: The strongest changes were in the prefrontal/frontal areas, where glucose metabolism increased significantly and cortical thickness decreased.

Anonymous Patient Answer
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