34 Participants Needed

Neuromodulation for Schizophrenia

PG
Overseen ByPhillip Gerretson, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Scion NeuroStim
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, on illness awareness in schizophrenia - a significant contributor to medication non-adherence and poor treatment outcomes, and arguably the most treatment resistant manifestation of the disorder. The study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.

Will I have to stop taking my current medications?

The trial requires that participants have been on a stable dose of their antipsychotic and other medications for at least 2 months before joining, and they should not expect to change doses during the study.

What data supports the effectiveness of the treatment for schizophrenia?

Research shows that non-invasive brain stimulation techniques, like repetitive transcranial magnetic stimulation (rTMS), have shown promise in treating symptoms of schizophrenia, such as negative symptoms and auditory hallucinations. However, more research is needed to fully understand their effectiveness and improve treatment outcomes.12345

Is neuromodulation safe for humans?

Research on non-invasive brain stimulation, including techniques like transcutaneous vagus nerve stimulation (tVNS), shows that these methods are generally well tolerated with no significant adverse effects reported in studies involving schizophrenia patients.12367

How is the non-invasive brainstem modulation device treatment for schizophrenia different from other treatments?

The non-invasive brainstem modulation device is unique because it uses non-invasive brain stimulation to potentially improve symptoms of schizophrenia by modulating neural plasticity (the brain's ability to change and adapt), which is different from traditional drug treatments that primarily target chemical imbalances in the brain.248910

Eligibility Criteria

This trial is for adults over 18 with schizophrenia or schizoaffective disorder, who have trouble recognizing their illness. They must speak English, be on stable medication for two months, and able to consent. Excluded are those with recent eye surgery, ear infections, substance dependence (except caffeine/nicotine), metal implants/pacemakers affecting MRI scans, pregnancy, vestibular dysfunction, severe medical conditions or thought disorders.

Inclusion Criteria

Moderate-to-severe lack of illness awareness ≤7 on the VAGUS-SR, which corresponds to a rating of ≥3 on PANSS G12 Insight and Judgment item
I am willing and able to agree to participate in this study.
Fluent in English
See 2 more

Exclusion Criteria

Unwilling or unable to consent to the study
I use hearing aids or have chronic ear problems.
Metal implants or a pacemaker that would preclude the MRI scan
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brainstem neuromodulation using an investigational study device, with neuroimaging to measure brain changes

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Non-invasive brainstem modulation device
Trial Overview The study tests a non-invasive brainstem modulation device's effect on illness awareness in schizophrenia patients. It involves safe brain stimulation alongside neuroimaging to track changes in the brain related to treatment response and recognition of the illness.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Investigational Stimulation Pattern-Open LabelExperimental Treatment1 Intervention
Group II: Investigational Stimulation Pattern 2-RandomizedExperimental Treatment1 Intervention
Group III: Investigational Stimulation Pattern 1-RandomizedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Scion NeuroStim

Lead Sponsor

Trials
14
Recruited
550+

Centre for Addiction and Mental Health

Collaborator

Trials
388
Recruited
84,200+

Findings from Research

Non-invasive brain stimulation techniques, particularly repetitive transcranial magnetic stimulation (rTMS), show promise as add-on therapies for managing difficult symptoms of schizophrenia, such as negative symptoms and persistent auditory hallucinations, although some studies have reported mixed results.
Electroconvulsive therapy (ECT) remains the most established treatment, while newer methods like rTMS and transcranial direct current stimulation (tDCS) offer potential based on a better understanding of the underlying brain mechanisms, but further research is needed to confirm their clinical efficacy.
[Non-invasive brain stimulation for treatment of schizophrenic psychoses].Hasan, A., Wobrock, T., Palm, U., et al.[2018]
Recent randomized-controlled trials indicate that noninvasive brain stimulation can provide long-lasting relief from symptoms in patients with treatment-resistant schizophrenia.
Innovative stimulation techniques, such as theta burst stimulation and new electrical methods, have shown promising results, suggesting that optimizing stimulation parameters could enhance treatment efficacy for schizophrenia.
Recent advances in noninvasive brain stimulation for schizophrenia.Brunelin, J., Adam, O., Mondino, M.[2023]
A study involving 20 stable schizophrenia patients tested the safety and efficacy of transcutaneous vagus nerve stimulation (tVNS) over 26 weeks, finding that the treatment was well tolerated with no significant adverse effects.
However, the study did not show a statistically significant improvement in schizophrenia symptoms compared to sham stimulation, suggesting that while tVNS is safe, it may not be effective for this condition in the current trial setup.
Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study.Hasan, A., Wolff-Menzler, C., Pfeiffer, S., et al.[2018]

References

[Non-invasive brain stimulation for treatment of schizophrenic psychoses]. [2018]
Recent advances in noninvasive brain stimulation for schizophrenia. [2023]
Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study. [2018]
Modulating neural plasticity with non-invasive brain stimulation in schizophrenia. [2022]
Assessment of treatment resistance criteria in non-invasive brain stimulation studies of schizophrenia. [2022]
Moderate effects of noninvasive brain stimulation of the frontal cortex for improving negative symptoms in schizophrenia: Meta-analysis of controlled trials. [2019]
Managing Negative Symptoms of Schizophrenia: How Far Have We Come? [2018]
Electroconvulsive Therapy and Other Neuromodulation Techniques for the Treatment of Psychosis. [2019]
Non-pharmacological biological therapies in schizophrenia. [2018]
Neuromodulation to Treat Substance Use Disorders in People With Schizophrenia and Other Psychoses: A Systematic Review. [2022]
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