Neuromodulation for Schizophrenia

This trial explores a new method to help people with schizophrenia better understand and manage their illness. It employs a safe, non-invasive brainstem modulation device to gently stimulate the brainstem and track brain changes using imaging. The trial includes different groups testing various stimulation patterns. Suitable participants have schizophrenia or schizoaffective disorder and struggle with understanding their illness despite stable medication use. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative research that could lead to new insights and treatments.

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.

Research shows that non-invasive brainstem modulation is generally safe, stimulating the brainstem without surgery or other invasive methods. Most participants tolerate it well and experience no serious side effects.

In past studies of similar techniques, such as transcranial magnetic stimulation, some participants reported minor side effects, including mild headaches or slight discomfort at the stimulation site. However, these effects typically resolve quickly on their own.

Researchers are excited about neuromodulation for schizophrenia because it offers a non-invasive approach to treatment, unlike traditional antipsychotic medications that often come with a range of side effects. This treatment uses a brainstem modulation device, which directly targets neural pathways involved in schizophrenia, potentially leading to more precise and effective management of symptoms. By focusing on specific brain regions rather than altering chemical balances throughout the entire brain, this method could minimize side effects and improve patient outcomes significantly. Additionally, the non-invasive nature of the treatment could make it more accessible and less intimidating for patients compared to current standard treatments like antipsychotic drugs or electroconvulsive therapy.

Research has shown that using a non-invasive device on the brainstem might alleviate symptoms of schizophrenia, particularly by enhancing patients' understanding of their illness. A review of several studies has found that different non-invasive brain stimulation methods can effectively treat the negative symptoms of schizophrenia. Another review highlighted that these techniques might improve social skills in people with the condition. Additionally, a study with 644 patients demonstrated that non-invasive brain stimulation improved negative symptoms. In this trial, participants will receive one of the investigational stimulation patterns using the brainstem modulation device. These findings suggest that the brainstem modulation device under study could increase illness awareness and possibly improve treatment outcomes for schizophrenia.¹⁵⁶⁷⁸