NCT03048370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

December 14, 2016

Last Update Submit

February 7, 2024

Conditions

SchizophreniaHealthy

Outcome Measures

Primary Outcomes (1)

  • Nystagmus response (peak slow phase velocity)

    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 Outcomes (1)

  • Illness awareness

    Before CVS session and10 min after CVS session

Study Arms (6)

Left body temperature VS

EXPERIMENTAL

Left body temperature (37°C) vestibular stimulation

Procedure: Left body temperature VS

Right body temperature VS

EXPERIMENTAL

Right body temperature (37°C) vestibular stimulation

Procedure: Right body temperature VS

Left warm CVS

EXPERIMENTAL

Left warm (44°C) caloric vestibular stimulation

Procedure: Left warm CVS

Right warm CVS

EXPERIMENTAL

Right warm (44°C) caloric vestibular stimulation

Procedure: Right warm CVS

Left cold CVS

EXPERIMENTAL

Left cold (30°C) caloric vestibular stimulation

Procedure: Left cold CVS

Right cold CVS

EXPERIMENTAL

Right cold (30°C) caloric vestibular stimulation

Procedure: Right cold CVS

Interventions

Left body temperature VSPROCEDURE

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 body temperature VS
Right body temperature VSPROCEDURE

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 VS
Left warm CVSPROCEDURE

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 CVS
Right warm CVSPROCEDURE

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 CVS
Left cold CVSPROCEDURE

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 CVS
Right cold CVSPROCEDURE

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 CVS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Philip Gerretsen, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participant will be blinded to the order of experimental conditions, as well as the person conducting specific ratings assessments.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will successively receive 6 vestibular stimulation conditions. Side of stimulation will be randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2016

First Posted

February 9, 2017

Study Start

January 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)