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

NCT ID: NCT03918577

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2026-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obsessive-Compulsive Disorder Body Dysmorphic Disorders Illness Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized, controlled crossover study
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Caloric Vestibular Stimulation

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Caloric Vestibular Stimulation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Peter J van Roessel, MD PhD

Clinical Assistant Professor, Dept. Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter J van Roessel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pavithra Mukunda, MS

Role: CONTACT

650-723-4095

Maria Filippou-Frye, MD, MBS

Role: CONTACT

650-723-4095

Facility Contacts

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Pavithra Makunda, MS

Role: primary

650-723-4095

Sindu Menon, MBBS

Role: backup

650-723-4095

Related Links

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Other Identifiers

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45068

Identifier Type: -

Identifier Source: org_study_id