The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia

NCT05957484 | Terminated FDA Device

• 1 other identifier: 105-2017
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Schizophrenia; Anosognosia

Keywords

Non-invasive neuromodulation; Illness awareness; Magnetic resonance imaging; Medical device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Brain network activity

  At baseline and post-intervention.

Study Arms (3)

Active Treatment

ACTIVE COMPARATOR

Study participants will receive \~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device.

Device: Investigational brainstem neuromodulation device

Sham Treatment

PLACEBO COMPARATOR

Study participants will receive \~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device.

Device: Investigational brainstem neuromodulation device

Open Label

EXPERIMENTAL

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.

Device: Investigational brainstem neuromodulation device

Interventions

Investigational brainstem neuromodulation device 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.

Active Treatment; Open Label; Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to consent to the study
• Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
• Had eye surgery within the previous three (3) months
• Ear surgery within 6 months prior to entering the study
• Active ear infection or perforated tympanic membrane
• Diagnosis of vestibular dysfunction
• Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
• Acute suicidal and/or homicidal ideation
• Formal thought disorder rating ≥4 on PANSS item P2
• DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
• Positive urine drug screen at the screening visit
• Metal implants or a pacemaker that would preclude the MRI scan
• Pregnancy

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Scion NeuroStim: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related 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.

MeSH Terms

Conditions

Schizophrenia; Agnosia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Gerretsen, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 24, 2023
• Study Start: September 12, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)