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出境医 / 临床实验 / Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders

Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders

Study Description
Brief Summary:
This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Body Dysmorphic Disorders Illness Anxiety Disorder Other: Caloric Vestibular Stimulation Not Applicable

Detailed Description:

Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.

This study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, controlled crossover study
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: right cold caloric vestibular stimulation
OCRD participants in this arm will receive an approx 60 second infusion of distilled cold(4)c water in their right external ear canal, with before and after measures of OCRD symptom severity and insight.
 Other: Caloric Vestibular Stimulation
Cold water creates a convection current in the semicircular canal of the vestibular apparatus, leading to brief (<3 min) and typically well tolerated sense of rotational movement. Similar stimulation is routinely used in standard vestibular diagnostic testing.
Experimental: left cold caloric vestibular stimulation
OCRD participants in this arm will receive an approx 60 second infusion of distilled cold(4)c water in their left external ear canal, with before and after measures of OCRD symptom severity and insight.
 Other: Caloric Vestibular Stimulation
Cold water creates a convection current in the semicircular canal of the vestibular apparatus, leading to brief (<3 min) and typically well tolerated sense of rotational movement. Similar stimulation is routinely used in standard vestibular diagnostic testing.
Outcome Measures
Primary Outcome Measures :
  1. change in clinical insight as measured by the Brown Assessment of Beliefs (BABS). [ Time Frame: 1 hour ]
    Changes in clinical insight will be rated using the BABS, a gold-standard measure for assessing multiple dimensions of clinical insight across psychiatric disorders. The BABS is a 24 point scale for which scores ≥13 suggest poor or absent insight.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding "with predominant pain")
  • Strongly held OCRD-related concerns meeting BABS score criterion.
  • No recent change in psychopharmacological treatment, if any
  • Capacity to provide informed consent

Exclusion Criteria:

  • Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
  • Pregnant or nursing women
  • Active or recent substance use
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Pavithra Mukunda, MS 650-723-4095 ocdresearch@stanford.edu
Contact: Maria Filippou-Frye, MD, MBS 650-723-4095 ocdresearch@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Peter J van Roessel, MD, PhD Stanford University
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 20, 2021
Estimated Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019) 		change in clinical insight as measured by the Brown Assessment of Beliefs (BABS). [ Time Frame: 1 hour ]
Changes in clinical insight will be rated using the BABS, a gold-standard measure for assessing multiple dimensions of clinical insight across psychiatric disorders. The BABS is a 24 point scale for which scores ≥13 suggest poor or absent insight.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Official Title  ICMJE Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Brief Summary This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.
Detailed Description

Obsessive-compulsive and related disorders (OCRD), including obsessive compulsive disorder and body dysmorphic disorder, are chronic and disabling conditions characterized by recurrent intrusive thoughts and associated compulsive behaviors that affect millions of individuals in the US each year. Individuals affected by OCRD differ in insight, or the degree to which they understand their intrusive thoughts to reflect illness. Impairments in insight limit individuals' motivation to engage in care and predict worse outcome in those who access treatment.

This study seeks to explore whether unilateral stimulation of the vestibular system, which activates cortical areas hypothesized to underlie clinical insight, may beneficially modulate insight in individuals with OCRD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
randomized, controlled crossover study
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Obsessive-Compulsive Disorder
  • Body Dysmorphic Disorders
  • Illness Anxiety Disorder
Intervention  ICMJE Other: Caloric Vestibular Stimulation
Cold water creates a convection current in the semicircular canal of the vestibular apparatus, leading to brief (<3 min) and typically well tolerated sense of rotational movement. Similar stimulation is routinely used in standard vestibular diagnostic testing.
Study Arms  ICMJE
  • Experimental: right cold caloric vestibular stimulation
    OCRD participants in this arm will receive an approx 60 second infusion of distilled cold(4)c water in their right external ear canal, with before and after measures of OCRD symptom severity and insight.
    Intervention: Other: Caloric Vestibular Stimulation
  • Experimental: left cold caloric vestibular stimulation
    OCRD participants in this arm will receive an approx 60 second infusion of distilled cold(4)c water in their left external ear canal, with before and after measures of OCRD symptom severity and insight.
    Intervention: Other: Caloric Vestibular Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019) 		16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-65
  • Primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder or Somatic Symptom Disorder (excluding "with predominant pain")
  • Strongly held OCRD-related concerns meeting BABS score criterion.
  • No recent change in psychopharmacological treatment, if any
  • Capacity to provide informed consent

Exclusion Criteria:

  • Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
  • Pregnant or nursing women
  • Active or recent substance use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pavithra Mukunda, MS 650-723-4095 ocdresearch@stanford.edu
Contact: Maria Filippou-Frye, MD, MBS 650-723-4095 ocdresearch@stanford.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918577
Other Study ID Numbers  ICMJE 45068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter J van Roessel, MD PhD, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter J van Roessel, MD, PhD Stanford University
PRS Account Stanford University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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