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Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia

Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03048370
Enrollment
40
Registered
2017-02-09
Start date
2019-01-01
Completion date
2023-12-31
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Schizophrenia

Brief 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. 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).

Interventions

PROCEDURELeft body temperature VS

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

PROCEDURERight body temperature VS

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

PROCEDURELeft warm CVS

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

PROCEDURERight warm CVS

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

PROCEDURELeft cold CVS

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

PROCEDURERight cold CVS

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

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The participant will be blinded to the order of experimental conditions, as well as the person conducting specific ratings assessments.

Intervention model description

Each participant will successively receive 6 vestibular stimulation conditions. Side of stimulation will be randomized.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for Schizophrenia group: 1. Male or female inpatients or outpatients age ≥18 2. Having a DSM-5 diagnosis of schizophrenia or schizoaffective disorder 3. Voluntary and capable of consenting to participation in the research study 4. Fluent in English Inclusion Criteria for Healthy Controls group: 1. Male or female and age ≥18 2. Voluntary and capable of consenting to participation in the research study 3. Fluent in English 4. Absence of history of psychiatric illness using the Mini-International Neuropsychiatric Interview (MINI)

Exclusion criteria

for all participants: 1. Serious unstable medical illness or any concomitant major medical or neurological illness 2. Acute suicidal and/or homicidal ideation 3. Formal thought disorder rating of over 2 on the Scale for Assessment of Positive Symptoms (SAPS) \[patients only\] 4. DSM-IV substance dependence (except caffeine and nicotine) within one month prior to entering the study 5. Pregnant women 6. Positive urine drug screen 7. History of external or middle ear pathology 8. History or signs of middle ear surgery (e.g. Tympanoplasty, mastoidectomy) 9. Signs of active ear disease

Design outcomes

Primary

MeasureTime frameDescription
Nystagmus response (peak slow phase velocity)Between 30 and 60 sec after each CVS conditionNystagmus response will be measured at between thirty and 60 seconds post irrigations, looking for the highest velocities.

Secondary

MeasureTime frameDescription
Illness awarenessBefore CVS session and10 min after CVS sessionChanges in illness awareness will be assessed using a questionnaire.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026