Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Primary Purpose
Obsessive-Compulsive Disorder, Body Dysmorphic Disorders, Illness Anxiety Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caloric Vestibular Stimulation
Sponsored by
About this trial
This is an interventional other trial for Obsessive-Compulsive Disorder focused on measuring Caloric Vestibular Stimulation, Insight
Eligibility 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
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
right cold caloric vestibular stimulation
left cold caloric vestibular stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03918577
Brief Title
Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Official Title
Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Body Dysmorphic Disorders, Illness Anxiety Disorder
Keywords
Caloric Vestibular Stimulation, Insight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized, controlled crossover study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
right cold caloric vestibular stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
left cold caloric vestibular stimulation
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Caloric Vestibular Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavithra Mukunda, MS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Filippou-Frye, MD, MBS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J van Roessel, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavithra Makunda, MS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Sindu Menon, MBBS
Phone
650-723-4095
Email
ocdresearch@stanford.edu
First Name & Middle Initial & Last Name & Degree
Peter van Roessel, MD, PhD
12. IPD Sharing Statement
Links:
URL
https://med.stanford.edu/profiles/peter-van-roessel
Description
Stanford Medicine Faculty Page
URL
http://med.stanford.edu/rodriguezlab/research.html
Description
Rodriguez Lab Website
Learn more about this trial
Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
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