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NCT Number: NCT03918577

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Body Dysmorphic Disorders Illness Anxiety Disorder Mental Disorders Somatoform Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caloric Vestibular Stimulation

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.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Filippou-Frye, MD, MBS

CONTACT

[email protected]

650-723-4095

Pavithra Mukunda, MS

CONTACT

[email protected]

650-723-4095

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2019
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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