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RECRUITING
NCT05580211
NA

Neuromodulation for Schizophrenia

Sponsor: Scion NeuroStim

View on ClinicalTrials.gov

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

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.

Locations (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada