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

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder; Body Dysmorphic Disorders; Illness Anxiety Disorder
• Interventions: Other: Caloric Vestibular Stimulation

• Registration Number: NCT03918577
• Lead Sponsor: Stanford University

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 Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Study Start: 2022-05-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
right cold caloric vestibular stimulation	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.
left cold caloric vestibular stimulation	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.

Primary Outcome Measures

Name	Time	Method
change in clinical insight as measured by the Brown Assessment of Beliefs (BABS).	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States