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Recruiting NCT03918577

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

No phase Interventional Obsessive-Compulsive Disorder Body Dysmorphic Disorders Illness Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caloric Vestibular Stimulation.
Who it may be relevant to
Registry conditions: Obsessive-Compulsive Disorder, Body Dysmorphic Disorders, Illness Anxiety Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • change in clinical insight as measured by the Brown Assessment of Beliefs (BABS). [Time frame: 1 hour]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT03918577 · 45068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗