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Neuromodulation for Schizophrenia
Sponsor: Scion NeuroStim
Summary
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.
Official title: The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2023-10-03
Completion Date
2026-01-30
Last Updated
2024-12-17
Healthy Volunteers
No
Conditions
Interventions
Non-invasive brainstem modulation device (stimulation Randomized)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 4 weeks using a non-invasive brainstem modulation device.
Non-invasive brainstem modulation device (stimulation-Open Label)
Study participants will receive \~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
Locations (1)
Centre for Addiction and Mental Health
Toronto, Ontario, Canada