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

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

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder; Body Dysmorphic Disorders; Illness Anxiety Disorder
• Intervention / Treatment: Other: Caloric Vestibular Stimulation

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: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pavithra Mukunda, MS; Phone Number: 650-723-4095; Email: ocdresearch@stanford.edu
• Study Contact Backup: Name: Maria Filippou-Frye, MD, MBS; Phone Number: 650-723-4095; Email: ocdresearch@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Sindu Menon, MBBS; Phone Number: 650-723-4095; Email: ocdresearch@stanford.edu
      • Contact: Pavithra Makunda, MS; Phone Number: 650-723-4095; Email: ocdresearch@stanford.edu
      • Principal Investigator: Peter van Roessel, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Peter J van Roessel, MD, PhD, Stanford University

Publications and helpful links

Helpful Links

• Stanford Medicine Faculty Page
• Rodriguez Lab Website

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Insight; Caloric Vestibular Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Somatoform Disorders; Obsessive-Compulsive Disorder; Body Dysmorphic Disorders
• Other Study ID Numbers: 45068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No