What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). Side effects of SSRIs can include nausea, headache, sleep disturbances, and sexual dysfunction. Cognitive-behavioral therapy generally has fewer side effects but can cause temporary increases in anxiety as patients confront their fears. Deep brain stimulation (DBS), another treatment for severe OCD, can have surgical complications, device-related issues, and undesired effects from stimulation such as impulsivity, sleeping problems, or tension. While specific side effects of caloric vestibular stimulation are not detailed, vestibular stimulation in general has been associated with reduced anxiety, suggesting it may have a favorable side effect profile.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, and sertraline, as well as the tricyclic antidepressant clomipramine. These medications target serotonin pathways to alleviate OCD symptoms. While Caloric Vestibular Stimulation (CVS) is being studied for its potential to modulate cognitive and emotional processes through the vestibular system, there are no FDA-approved treatments for OCD that specifically utilize vestibular system stimulation. Current approved treatments are pharmacological and do not involve neuromodulation techniques like CVS.

What other types of research exist?

Promising, novel alternatives to Caloric Vestibular Stimulation for OCD patients include transcranial magnetic stimulation (TMS), transcranial direct-current stimulation (tDCS), and vagus nerve stimulation (VNS). These neuromodulation techniques have shown efficacy in modulating cognitive and emotional processes in related psychiatric conditions and may offer potential benefits for OCD treatment.

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Caloric Vestibular Stimulation for OCD

N/A

Recruiting

Led By Peter J van Roessel, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates if using warm or cold water in the ear can help people with obsessive-compulsive disorders better understand their condition by stimulating certain brain areas.

Who is the study for?

This trial is for adults aged 18-65 with a primary diagnosis of Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder, or Somatic Symptom Disorder. Participants should not have had recent changes in any psychopharmacological treatment and must be able to provide informed consent. Pregnant or nursing women, individuals with substance use issues or certain medical conditions like vertigo are excluded.

What is being tested?

The study is testing caloric vestibular stimulation—a procedure that involves stimulating the balance organs in the ears using temperature—to see if it can change how people with obsessive-compulsive spectrum disorders perceive their symptoms.

What are the potential side effects?

Caloric vestibular stimulation may cause temporary discomfort such as dizziness, nausea, or imbalance due to its effect on the inner ear's balance mechanisms.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: right cold caloric vestibular stimulationExperimental Treatment1 Intervention

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 II: left cold caloric vestibular stimulationExperimental Treatment1 Intervention

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs), deep brain stimulation (DBS), and cognitive-behavioral therapy (CBT). SSRIs work by increasing serotonin levels in the brain, which helps reduce OCD symptoms by improving mood and anxiety regulation. DBS involves implanting electrodes in specific brain areas to modulate neural circuits implicated in OCD, offering relief for treatment-resistant cases. CBT, particularly exposure and response prevention, helps patients confront and reduce compulsive behaviors through structured therapeutic techniques. These treatments are crucial as they target the underlying neurobiological and psychological mechanisms of OCD, providing symptom relief and improving quality of life. Caloric Vestibular Stimulation, which involves stimulating the vestibular system to modulate cognitive and emotional processes, represents a novel approach that could complement existing therapies by potentially influencing brain regions involved in OCD.

Vestibulo-ocular reflex.Advances in pharmacotherapy of vestibular and ocular motor disorders.Animal models of obsessive compulsive disorder: recent findings and future directions.