SchizophreniaNCT05580211
Neuromodulation for Schizophrenia
A study testing Non-invasive brainstem modulation device (stimulation Randomized) and Non-invasive brainstem modulation device (stimulation-Open Label) in people with Schizophrenia, run by Scion NeuroStim at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Non-invasive brainstem modulation device (stimulation Randomized) and Non-invasive brainstem modulation device (stimulation-Open Label)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario
Phillip Gerretson, MD, 416-535-8501 ext. 39426, Philip.Gerretsen@camh.ca
About this study
Official title: The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- Non-invasive brainstem modulation device (stimulation Randomized), Non-invasive brainstem modulation device (stimulation-Open Label)
- Keywords
- neuromodulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brainstem modulation device (stimulation Randomized)Device
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)Device
Study participants will receive ~19-minute treatments twice daily in the clinic setting over 8 weeks using a non-invasive brainstem modulation device.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Stimulation Pattern 1-Randomized | Other | Not described Receives: Device: Non-invasive brainstem modulation device (stimulation Randomized) |
| Investigational Stimulation Pattern 2-Randomized | Other | Not described Receives: Device: Non-invasive brainstem modulation device (stimulation Randomized) |
| Investigational Stimulation Pattern-Open Label | Other | Not described Receives: Device: Non-invasive brainstem modulation device (stimulation-Open Label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks from baseline to end of treatment
Secondary outcomes (1)
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.
Measured: 4 weeks from baseline to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start3 Oct 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580211
- Sponsor's protocol ID
- SNS-SCZ-001
- Status last verified
- Dec 2024
- First submitted
- 11 Oct 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. 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
- NCT05580211
- Acronym / sponsor ID
- SNS-SCZ-001
- Conditions
- Schizophrenia
- Keywords
- neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 14 Oct 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Stimulation Pattern 1-Randomized | Other | Device: Non-invasive brainstem modulation device (stimulation Randomized) |
| Investigational Stimulation Pattern 2-Randomized | Other | Device: Non-invasive brainstem modulation device (stimulation Randomized) |
| Investigational Stimulation Pattern-Open Label | Other | Device: Non-invasive brainstem modulation device (stimulation-Open Label) |
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 |
|---|---|---|
| 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. | Device | Investigational Stimulation Pattern 1-Randomized, Investigational Stimulation Pattern 2-Randomized |
| 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. | Device | Investigational Stimulation Pattern-Open Label |
Primary outcome
Illness Awareness
Time frame: 4 weeks from baseline to end of treatment
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.
1 secondary outcome
Examine changes in brain network activity
Time frame: 4 weeks from baseline to end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brainstem modulation device (stimulation Randomized) and Non-invasive brainstem modulation device (stimulation-Open Label) in people with Schizophrenia, run by Scion NeuroStim 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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip Gerretson, MD (416-535-8501 ext. 39426, Philip.Gerretsen@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness Awareness (time frame: 4 weeks from baseline to end of treatment). 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 17 Dec 2024.