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Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia

Primary Purpose

Schizophrenia, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Left body temperature VS
Right body temperature VS
Left warm CVS
Right warm CVS
Left cold CVS
Right cold CVS
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Left body temperature VS

Right body temperature VS

Left warm CVS

Right warm CVS

Left cold CVS

Right cold CVS

Arm Description

Left body temperature (37°C) vestibular stimulation

Right body temperature (37°C) vestibular stimulation

Left warm (44°C) caloric vestibular stimulation

Right warm (44°C) caloric vestibular stimulation

Left cold (30°C) caloric vestibular stimulation

Right cold (30°C) caloric vestibular stimulation

Outcomes

Primary Outcome Measures

Nystagmus response (peak slow phase velocity)
Nystagmus response will be measured at between thirty and 60 seconds post irrigations, looking for the highest velocities.

Secondary Outcome Measures

Illness awareness
Changes in illness awareness will be assessed using a questionnaire.

Full Information

First Posted
December 14, 2016
Last Updated
September 14, 2023
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT03048370
Brief Title
Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia
Official Title
Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant will successively receive 6 vestibular stimulation conditions. Side of stimulation will be randomized.
Masking
ParticipantOutcomes Assessor
Masking Description
The participant will be blinded to the order of experimental conditions, as well as the person conducting specific ratings assessments.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left body temperature VS
Arm Type
Experimental
Arm Description
Left body temperature (37°C) vestibular stimulation
Arm Title
Right body temperature VS
Arm Type
Experimental
Arm Description
Right body temperature (37°C) vestibular stimulation
Arm Title
Left warm CVS
Arm Type
Experimental
Arm Description
Left warm (44°C) caloric vestibular stimulation
Arm Title
Right warm CVS
Arm Type
Experimental
Arm Description
Right warm (44°C) caloric vestibular stimulation
Arm Title
Left cold CVS
Arm Type
Experimental
Arm Description
Left cold (30°C) caloric vestibular stimulation
Arm Title
Right cold CVS
Arm Type
Experimental
Arm Description
Right cold (30°C) caloric vestibular stimulation
Intervention Type
Procedure
Intervention Name(s)
Left body temperature VS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Right body temperature VS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Left warm CVS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Right warm CVS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Left cold CVS
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Right cold CVS
Intervention Description
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
Primary Outcome Measure Information:
Title
Nystagmus response (peak slow phase velocity)
Description
Nystagmus response will be measured at between thirty and 60 seconds post irrigations, looking for the highest velocities.
Time Frame
Between 30 and 60 sec after each CVS condition
Secondary Outcome Measure Information:
Title
Illness awareness
Description
Changes in illness awareness will be assessed using a questionnaire.
Time Frame
Before CVS session and10 min after CVS session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Schizophrenia group: 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 Inclusion Criteria for Healthy Controls group: 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) Exclusion Criteria for all participants: 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 History of external or middle ear pathology History or signs of middle ear surgery (e.g. Tympanoplasty, mastoidectomy) Signs of active ear disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Gerretsen, MD, PhD
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Graff, MD, PhD
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Gerretsen, 416-535-8501
Phone
416-535-8501
Ext
39426
Email
philip.gerretsen@camh.ca
First Name & Middle Initial & Last Name & Degree
Ariel Graff, 416-535-8501
Phone
416-535-8501
Ext
34834
Email
ariel.graff@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.net/research
Description
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 Centre

Learn more about this trial

Reactivity of the Vestibular System to Caloric Vestibular Stimulation in Schizophrenia

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