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

Primary Purpose

Schizophrenia, Anosognosia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Investigational brainstem neuromodulation device
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Non-invasive neuromodulation, Illness awareness, Magnetic resonance imaging, Medical device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Active Treatment

Sham Treatment

Open Label

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Illness awareness
Changes in illness awareness will be assessed using questionnaires.

Secondary Outcome Measures

Brain network activity
Assess changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task)

Full Information

First Posted
June 13, 2023
Last Updated
September 12, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Scion NeuroStim
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1. Study Identification

Unique Protocol Identification Number
NCT05957484
Brief Title
The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Official Title
The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
September 15, 2026 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Scion NeuroStim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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: 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. 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Anosognosia
Keywords
Non-invasive neuromodulation, Illness awareness, Magnetic resonance imaging, Medical device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Study participants will receive ~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device.
Arm Title
Sham Treatment
Arm Type
Placebo Comparator
Arm Description
Study participants will receive ~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device.
Arm Title
Open Label
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Investigational brainstem neuromodulation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Illness awareness
Description
Changes in illness awareness will be assessed using questionnaires.
Time Frame
Illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.
Secondary Outcome Measure Information:
Title
Brain network activity
Description
Assess changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task)
Time Frame
At baseline and post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Gerretsen, MD, PhD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Graff, MD, PhD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PhD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name & Degree
Ariel Graff, MD, PhD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.net/research
Description
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.

Learn more about this trial

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

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