Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
1 other identifier
interventional
16
1 country
1
Brief Summary
This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
January 22, 2026
January 1, 2026
4.6 years
April 15, 2019
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
right cold caloric vestibular stimulation
EXPERIMENTALOCRD 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
EXPERIMENTALOCRD 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Psychiatric or medical conditions (eg, vertigo, history of otological surgery) that might make participation unsafe
- Pregnant or nursing women
- Active or recent substance use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94304, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter J van Roessel, MD, PhD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor, Dept. Psychiatry and Behavioral Sciences
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 17, 2019
Study Start
May 10, 2022
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01