Neuromodulation for Schizophrenia
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brainstem neuromodulation using an investigational study device, with neuroimaging to measure brain changes
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Non-invasive brainstem modulation device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Scion NeuroStim
Lead Sponsor
Centre for Addiction and Mental Health
Collaborator