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

Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to determine the clinical and functional imaging effects of serial CVS on illness awareness in schizophrenia. Specifically, the investigators aim to: 1. Determine if twice-daily CVS for 4 weeks will improve illness awareness compared to the sham condition in participants with schizophrenia. Illness awareness will be assessed at pre- and post-CVS, and weekly thereafter for 4 weeks. 2. Examine changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task) pre- and post-CVS. This will serve as a biomarker to rigorously test whether repeated CVS engages the PPA associated with illness awareness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female inpatients or outpatients ≥ 18 years of age

• Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder

• Voluntary and capable of consenting to participation in the research study

• Fluent in English

• Moderate-to-severe lack of illness awareness ≤7 on the VAGUS-SR, which corresponds to a rating of ≥3 on PANSS G12 Insight and Judgment item)

• On a stable dose of antipsychotic and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study

Locations
Other Locations
Canada
Centre for Addiction and Mental Health
Toronto
Time Frame
Start Date: 2023-09-12
Completion Date: 2025-02-11
Participants
Target number of participants: 4
Treatments
Active_comparator: Active Treatment
Study participants will receive \~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device.
Placebo_comparator: Sham Treatment
Study participants will receive \~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device.
Experimental: Open Label
After completion of sham or active stimulation over 4 weeks, participants can choose to receive \~18-minute active stimulation twice daily for up to 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Centre for Addiction and Mental Health
Collaborators: Scion NeuroStim

This content was sourced from clinicaltrials.gov