SchizophreniaNCT05957484
The Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
A study testing Investigational brainstem neuromodulation device in people with Schizophrenia and Anosognosia, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Anosognosia
- What is being tested?
- Investigational brainstem neuromodulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2023to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
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.
Read the 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.
- Conditions
- Schizophrenia, Anosognosia
- Being tested
- Investigational brainstem neuromodulation device
- Keywords
- Non-invasive neuromodulation, Illness awareness, Magnetic resonance imaging, Medical device
- Medical subject headings
- Schizophrenia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational brainstem neuromodulation deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Study participants will receive ~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device. Receives: 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. Receives: 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. Receives: Device: Investigational brainstem neuromodulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illness awareness
Changes in illness awareness will be assessed using questionnaires.
Measured: 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
Assess changes in brain network activity (blood oxygen level dependent-BOLD in response to an illness awareness task)
Measured: At baseline and post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start12 Sep 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Why it stopped: Study device no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Scion NeuroStim
- Responsible party
- Principal investigator, Philip Gerretsen, Centre for Addiction and Mental Health
- Investigators
- Philip Gerretsen, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957484
- Sponsor's protocol ID
- 105-2017
- Status last verified
- Mar 2025
- First submitted
- 13 Jun 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
- ClinicalTrials.gov ID
- NCT05957484
- Acronym / sponsor ID
- 105-2017
- Conditions
- Schizophrenia, Anosognosia
- Keywords
- Non-invasive neuromodulation, Illness awareness, Magnetic resonance imaging, Medical device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study device no longer available.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Scion NeuroStim
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: Investigational brainstem neuromodulation deviceStudy participants will receive ~18-minute active stimulation twice daily over 4 weeks, using a non-invasive brainstem modulation device. |
| Sham Treatment | Placebo comparator | Device: Investigational brainstem neuromodulation deviceStudy participants will receive ~18-minute of sham stimulation twice daily over 4 weeks using a non-invasive brainstem modulation device. |
| Open Label | Experimental | Device: Investigational brainstem neuromodulation deviceAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational brainstem neuromodulation deviceThis 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. | Device | Active Treatment, Open Label, Sham Treatment |
Primary outcome
Illness awareness
Time frame: Illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.
Changes in illness awareness will be assessed using questionnaires.
1 secondary outcome
Brain network activity
Time frame: At baseline and post-intervention.
Results and safety
The study was stopped early (reason given: Study device no longer available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Gerretsen, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational brainstem neuromodulation device in people with Schizophrenia and Anosognosia, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study device no longer available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness awareness (time frame: Illness awareness will be assessed at pre-intervention and immediately following the intervention and weekly for up to 4 weeks post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.