Neuromodulation for Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05580211
• Other study ID #: SNS-SCZ-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: January 30, 2026

Study information

• Verified date: October 2022
• Source: Scion NeuroStim
• Contact: Phillip Gerretson, MD
• Phone: 416-535-8501
• Email: Philip.Gerretsen[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: January 30, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female inpatients or outpatients = 18 years of age

2. Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder

3. Voluntary and capable of consenting to participation in the research study

4. Fluent in English

5. 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

6. 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

Exclusion Criteria:

1. Unwilling or unable to consent to the study

2. Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease

3. Had eye surgery within the previous three (3) months

4. Ear surgery within 6 months prior to entering the study

5. Active ear infection or perforated tympanic membrane

6. Diagnosis of vestibular dysfunction

7. Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures

8. Acute suicidal and/or homicidal ideation

9. Formal thought disorder rating =4 on PANSS item P2

10. DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study

11. Positive urine drug screen at the screening visit

12. Metal implants or a pacemaker that would preclude the MRI scan

13. Pregnancy

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.
• 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

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Scion NeuroStim	Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Illness Awareness	functional MRI paradigm. The paradigm consists of a bank of brief questions or statements to which participants respond either "yes/agree" or "no/disagree". The brief statements are derived from four categories: general illness awareness, symptom awareness and attribution, awareness of need for treatment, and illness independent/control.	4 weeks from baseline to end of treatment
Secondary	Examine changes in brain network activity	functional MRI blood oxygen level dependent (BOLD) in response to an illness awareness task pre- and post-treatment. This will serve as a biomarker to rigorously test whether repeated treatment engages the posterior parietal area of the brain associated with illness awareness.	4 weeks from baseline to end of treatment