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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
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obsessive-Compulsive Disorder focused on measuring Caloric Vestibular Stimulation, Insight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 15, 2019
Last Updated
September 27, 2023
Sponsor
Stanford University
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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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