SchizophreniaNCT03048370
Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia
A study testing Left body temperature VS, Right body temperature VS and Left warm CVS in people with Schizophrenia and Healthy, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study aims to determine if individuals with schizophrenia have greater reactivity to vestibular stimulation than healthy controls. The physiological response of vestibular stimulation will be assessed with electronystagmography, which provides a measure of the intensity of the nystagmus via PSPV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Healthy
- What is being tested?
- Left body temperature VS, Right body temperature VS and Left warm CVS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 31 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female inpatients or outpatients age ≥18
- Having a DSM-5 diagnosis of schizophrenia or schizoaffective disorder
- Voluntary and capable of consenting to participation in the research study
- Fluent in English
- Male or female and age ≥18
- Voluntary and capable of consenting to participation in the research study
- Fluent in English
- Absence of history of psychiatric illness using the Mini-International Neuropsychiatric Interview (MINI)
Who cannot join
- Serious unstable medical illness or any concomitant major medical or neurological illness
- Acute suicidal and/or homicidal ideation
- Formal thought disorder rating of over 2 on the Scale for Assessment of Positive Symptoms (SAPS) [patients only]
- DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study
- Pregnant women
- Positive urine drug screen
Show all 9Show fewer
- History of external or middle ear pathology
- History or signs of middle ear surgery (e.g. Tympanoplasty, mastoidectomy)
- Signs of active ear disease
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine if individuals with schizophrenia have greater reactivity to vestibular stimulation than healthy controls. The physiological response of vestibular stimulation will be assessed with electronystagmography, which provides a measure of the intensity of the nystagmus via PSPV. Positive results would suggest greater vestibular system reactivity to vestibular stimulation may be a biomarker of schizophrenia. Pathophysiologically, increased vestibular reactivity to vestibular stimulation may reflect abnormal vestibular function or impaired central suppression of the vestibular ocular reflex.
Read the detailed description
In schizophrenia, there is no conclusive link between psychopathology and vestibular dysfunction and we are not aware of any data that exists on the range of responses to caloric vestibular stimulation (CVS) in persons with schizophrenia. Initial data from another CVS study from our group suggests individuals with schizophrenia have greater reactivity to body temperature (37°C) CVS, as measured by the peak slow phase velocity of the resulting nystagmus (PSPV), than would be expected from individuals without schizophrenia versus healthy participants. Intriguingly, CVS at 37°C should not theoretically produce a significant vestibulocular reflex response due to the stimulus' approximation to body temperature. Hence, the primary aim of this study is to determine if individuals with schizophrenia will have greater vestibular reactivity, as measured by nystagmus PSPV, to CVS in comparison with healthy participants. The secondary aim is to assess illness awareness pre and post CVS administration in attempts to replicate our previous observation. A total of 20 patients with schizophrenia and 20 healthy control participants will be recruited. All participants will receive three conditions bilaterally: (1) body temperature (37°C) vestibular stimulation; (2) warm CVS (44°C), and (3) cold CVS (30°C).
- Conditions
- Schizophrenia, Healthy
- Being tested
- Left body temperature VS, Right body temperature VS, Left warm CVS, Right warm CVS, Left cold CVS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left body temperature VSProcedure or surgery
Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
Right body temperature VSProcedure or surgery
Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
Left warm CVSProcedure or surgery
Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
Right warm CVSProcedure or surgery
Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
Left cold CVSProcedure or surgery
Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
Right cold CVSProcedure or surgery
Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
| Study group | Role | What they receive |
|---|---|---|
| Left body temperature VS | Experimental | Left body temperature (37°C) vestibular stimulation Receives: Procedure: Left body temperature VS |
| Right body temperature VS | Experimental | Right body temperature (37°C) vestibular stimulation Receives: Procedure: Right body temperature VS |
| Left warm CVS | Experimental | Left warm (44°C) caloric vestibular stimulation Receives: Procedure: Left warm CVS |
| Right warm CVS | Experimental | Right warm (44°C) caloric vestibular stimulation Receives: Procedure: Right warm CVS |
| Left cold CVS | Experimental | Left cold (30°C) caloric vestibular stimulation Receives: Procedure: Left cold CVS |
| Right cold CVS | Experimental | Right cold (30°C) caloric vestibular stimulation Receives: Procedure: Right cold CVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nystagmus response (peak slow phase velocity)
Nystagmus response will be measured at between thirty and 60 seconds post irrigations, looking for the highest velocities.
Measured: Between 30 and 60 sec after each CVS condition
Secondary outcomes (1)
Illness awareness
Changes in illness awareness will be assessed using a questionnaire.
Measured: Before CVS session and10 min after CVS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will successively receive 6 vestibular stimulation conditions. Side of stimulation will be randomized.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- 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
- NCT03048370
- Sponsor's protocol ID
- 042-2016
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2016
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia
- ClinicalTrials.gov ID
- NCT03048370
- Acronym / sponsor ID
- 042-2016
- Conditions
- Schizophrenia, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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 if individuals with schizophrenia have greater reactivity to vestibular stimulation than healthy controls. The physiological response of vestibular stimulation will be assessed with electronystagmography, which provides a measure of the intensity of the nystagmus via PSPV. Positive results would suggest greater vestibular system reactivity to vestibular stimulation may be a biomarker of schizophrenia. Pathophysiologically, increased vestibular reactivity to vestibular stimulation may reflect abnormal vestibular function or impaired central suppression of the vestibular ocular reflex.
Detailed description
In schizophrenia, there is no conclusive link between psychopathology and vestibular dysfunction and we are not aware of any data that exists on the range of responses to caloric vestibular stimulation (CVS) in persons with schizophrenia. Initial data from another CVS study from our group suggests individuals with schizophrenia have greater reactivity to body temperature (37°C) CVS, as measured by the peak slow phase velocity of the resulting nystagmus (PSPV), than would be expected from individuals without schizophrenia versus healthy participants. Intriguingly, CVS at 37°C should not theoretically produce a significant vestibulocular reflex response due to the stimulus' approximation to body temperature. Hence, the primary aim of this study is to determine if individuals with schizophrenia will have greater vestibular reactivity, as measured by nystagmus PSPV, to CVS in comparison with healthy participants. The secondary aim is to assess illness awareness pre and post CVS administration in attempts to replicate our previous observation. A total of 20 patients with schizophrenia and 20 healthy control participants will be recruited. All participants will receive three conditions bilaterally: (1) body temperature (37°C) vestibular stimulation; (2) warm CVS (44°C), and (3) cold CVS (30°C).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Each participant will successively receive 6 vestibular stimulation conditions. Side of stimulation will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Left body temperature VS | Experimental | Procedure: Left body temperature VSLeft body temperature (37°C) vestibular stimulation |
| Right body temperature VS | Experimental | Procedure: Right body temperature VSRight body temperature (37°C) vestibular stimulation |
| Left warm CVS | Experimental | Procedure: Left warm CVSLeft warm (44°C) caloric vestibular stimulation |
| Right warm CVS | Experimental | Procedure: Right warm CVSRight warm (44°C) caloric vestibular stimulation |
| Left cold CVS | Experimental | Procedure: Left cold CVSLeft cold (30°C) caloric vestibular stimulation |
| Right cold CVS | Experimental | Procedure: Right cold CVSRight cold (30°C) caloric vestibular stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female inpatients or outpatients age ≥18
- Having a DSM-5 diagnosis of schizophrenia or schizoaffective disorder
- Voluntary and capable of consenting to participation in the research study
- Fluent in English
- Male or female and age ≥18
Key exclusion criteria (9 listed)
- Serious unstable medical illness or any concomitant major medical or neurological illness
- Acute suicidal and/or homicidal ideation
- Formal thought disorder rating of over 2 on the Scale for Assessment of Positive Symptoms (SAPS) [patients only]
- DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study
- Pregnant women
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 |
|---|---|---|
| Left body temperature VSCaloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function | Procedure or surgery | Left body temperature VS |
| Right body temperature VSCaloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function | Procedure or surgery | Right body temperature VS |
| Left warm CVSCaloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function | Procedure or surgery | Left warm CVS |
| Right warm CVSCaloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function | Procedure or surgery | Right warm CVS |
| Left cold CVSCaloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function | Procedure or surgery | Left cold CVS |
| Right cold CVSCaloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function | Procedure or surgery | Right cold CVS |
Primary outcome
Nystagmus response (peak slow phase velocity)
Time frame: Between 30 and 60 sec after each CVS condition
Nystagmus response will be measured at between thirty and 60 seconds post irrigations, looking for the highest velocities.
1 secondary outcome
Illness awareness
Time frame: Before CVS session and10 min after CVS session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink 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 Left body temperature VS, Right body temperature VS and Left warm CVS in people with Schizophrenia and Healthy, 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 8 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nystagmus response (peak slow phase velocity) (time frame: Between 30 and 60 sec after each CVS condition). 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 8 Feb 2024.