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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918577
• Other study ID #: 45068
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: Pavithra Mukunda, MS
• Phone: 650-723-4095
• Email: ocdresearch[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Body Dysmorphic Disorders
• Illness Anxiety Disorder
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Rodriguez Lab Website
•   Stanford Medicine Faculty Page