What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly neuromodulation therapies like Intermittent Theta Burst Stimulation (iTBS) and repetitive transcranial magnetic stimulation (rTMS), are generally well-tolerated but can have side effects such as headaches, scalp discomfort, and, rarely, seizures. Other treatments, such as antipsychotic medications, can cause side effects including weight gain, metabolic syndrome, extrapyramidal symptoms (like tremors and rigidity), and sedation. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation antipsychotics such as risperidone, olanzapine, and aripiprazole. These medications primarily target dopamine receptors to alleviate symptoms. While iTBS is a neuromodulation technique being studied for its effects on the dorsolateral prefrontal cortex (DLPFC) and working memory in schizophrenia, it is not yet FDA-approved for this indication. Current treatments do not typically include neuromodulation techniques like iTBS, which are still under investigation.

What other types of research exist?

Promising alternatives to iTBS for schizophrenia patients include transcranial magnetic stimulation (TMS), which has shown efficacy in enhancing neurocognition and reducing depressive symptoms, and transcranial direct current stimulation (tDCS), which has been found to improve neurocognition and mood in various psychiatric conditions. Vagus nerve stimulation (VNS) is another option, particularly for treatment-resistant cases, with evidence supporting its long-term efficacy in mood stabilization.

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Behavioural Intervention

Theta Burst Stimulation for Schizophrenia (REDOCS Trial)

N/A

Recruiting

Led By Fabio Ferrarelli, MD, PhD

Research Sponsored by Fabio Ferrarelli

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM diagnoses of Schizophrenia Spectrum Axis I disorders

Ages 18-40 years

Must not have

Medical illness affecting brain structure or function

History of electroconvulsive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre itbs), within one hour from itbs

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a special type of brain stimulation called iTBS can improve brain activity and memory in people with early-stage schizophrenia. The treatment uses magnetic pulses to boost brain rhythms in a specific area linked to memory. Researchers will compare the effects of different treatments to see if iTBS makes a difference. Intermittent theta burst stimulation (iTBS) is a noninvasive brain stimulation technique that has shown promise in treating various psychiatric and neurological conditions, including treatment-resistant depression and cognitive impairments.

Who is the study for?

This trial is for individuals aged 18-40 with early-course schizophrenia, having experienced psychosis for less than three years. Participants must have a diagnosis within the Schizophrenia Spectrum and be able to give informed consent. It's not open to those who are pregnant or recently postpartum, have diabetes with certain complications, significant neurological disorders, substance dependence (except cannabis/alcohol), or a history of severe head injury.

What is being tested?

The study tests if Theta Burst Stimulation (iTBS) can improve brain function and memory in people with early schizophrenia. iTBS uses magnetic pulses on the brain while EEG tracks activity changes. Participants will receive either real iTBS or a sham treatment without active stimulation to compare effects on working memory.

What are the potential side effects?

While iTBS is generally considered safe, potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or temporary hearing issues due to the noise during treatment. Rarely it could cause seizures but this is closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a schizophrenia spectrum disorder.

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a medical condition that affects my brain.

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I have undergone electroconvulsive therapy.

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I or someone in my family has epilepsy.

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I have diabetes with seizures, limb issues, or brief losses of consciousness.

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I had a concussion where I was unconscious for more than 10 minutes.

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I have a serious neurological condition, like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre itbs), within one hour from itbs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre itbs), within one hour from itbs

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre itbs), within one hour from itbs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in AX-Continuous Performance Task Error Rate (AX-CPT ER) following iTBS

Change in AX-Continuous Performance Task Reaction Time (AX-CPT RT) following iTBS

Change in AX-Continuous Performance Task d' context (AX-CPT d') following iTBS

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: sham, then active intermittent Theta Burst Stimulation (iTBS) over DLPFCExperimental Treatment2 Interventions

This arm will first receive sham iTBS (i.e., with the TMS coil in the placebo orientation) and then active iTBS stimulation over the left dorsolateral prefrontal cortex (DLPFC).

Group II: active, then sham Intermittent Theta Burst Stimulation (iTBS) over DLPFCExperimental Treatment2 Interventions

This arm will first receive active iTBS stimulation and then sham iTBS over the left dorsolateral prefrontal cortex (DLPFC).

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia include antipsychotic medications and neuromodulation therapies. Antipsychotic medications, such as risperidone and olanzapine, primarily work by blocking dopamine receptors, which helps reduce symptoms like hallucinations and delusions. Neuromodulation therapies, such as repetitive transcranial magnetic stimulation (rTMS) and Intermittent Theta Burst Stimulation (iTBS), aim to modulate brain activity by stimulating specific brain regions like the dorsolateral prefrontal cortex (DLPFC). These treatments are important for schizophrenia patients because they target the underlying neural dysregulation associated with the disorder, potentially improving cognitive function and reducing symptoms. iTBS, in particular, may enhance oscillatory activity in the DLPFC, which is crucial for working memory and executive function, areas often impaired in schizophrenia.