Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia

February 7, 2024 updated by: Philip Gerretsen, Centre for Addiction and Mental Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left body temperature VS
Left body temperature (37°C) vestibular stimulation
Procedure: Left 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
Experimental: Right body temperature VS
Right body temperature (37°C) vestibular stimulation
Procedure: Right 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
Experimental: Left warm CVS
Left warm (44°C) caloric vestibular stimulation
Procedure: Left 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
Experimental: Right warm CVS
Right warm (44°C) caloric vestibular stimulation
Procedure: Right 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
Experimental: Left cold CVS
Left cold (30°C) caloric vestibular stimulation
Procedure: Left 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
Experimental: Right cold CVS
Right cold (30°C) caloric vestibular stimulation
Procedure: Right 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 30 and 60 sec after each CVS condition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illness awareness
Time Frame: Before CVS session and10 min after CVS session
Changes in illness awareness will be assessed using a questionnaire.
Before CVS session and10 min after CVS session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Philip Gerretsen, MD, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 042-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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