NCT05580211

Neuromodulation for Schizophrenia

The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Scion NeuroStim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2023-10-03
• Primary completion: 2025-10-30
• Completion: 2026-01-30
• First posted: 2022-10-14
• Last updated: 2024-12-17

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study