The Effects of Non-invasive Neuromodulation on Illness Awareness in 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: Recruiting

Administrative data

• NCT number: NCT05957484
• Other study ID #: 105-2017
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: September 15, 2026

Study information

• Verified date: September 2023
• Source: Centre for Addiction and Mental Health
• Contact: Philip Gerretsen, MD, PhD
• Phone: 416-535-8501
• Email: philip.gerretsen[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The proposed study employs a novel approach to determine the clinical and functional imaging effects of CVS 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. CVS is a traditionally safe and non-invasive method of vestibular stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with CVS and illness awareness. The results of this study will provide solid evidence for larger treatment-controlled effectiveness studies to determine if CVS is a practical means of producing lasting effects on illness awareness in individuals with schizophrenia or whether maintenance CVS treatment is required.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2026
• 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

• Anosognosia
• Schizophrenia

Intervention

Device:
• Investigational brainstem neuromodulation device
This study device is non-invasive meaning it stays outside of the body. It stimulates activity in the brain through a headset with metallic earpieces that fit into the participant's ear canals. The device will be loaded with certain neurostimulation pattern, and the earpieces will provide the stimulation at the prescribed pattern.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Scion NeuroStim

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Illness awareness	Changes in illness awareness will be assessed using questionnaires.	Illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.
Secondary	Brain network activity	Assess changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task)	At baseline and post-intervention.

External Links

•   The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.