Caloric Vestibular Stimulation for OCD

Overseen By Maria Filippou-Frye, MD, MBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Vertigo, Otological surgery, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether caloric vestibular stimulation, which involves placing cold water in the ear, can improve insight in individuals with certain obsessive-compulsive spectrum disorders. The goal is to determine if this treatment can alter how participants understand and manage their symptoms. The trial consists of two parts: one applying cold water to the left ear and another to the right ear. It suits adults diagnosed with obsessive-compulsive disorder or related conditions who haven't recently changed their medication. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment approaches.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that there should be no recent change in your psychopharmacological treatment (medications for mental health conditions). This suggests you may need to stay on your current medications without changes.

What prior data suggests that caloric vestibular stimulation is safe for OCD?

Research has shown that caloric vestibular stimulation is generally safe. This method often uses warm or cold water or air to gently stimulate the ear canal. Although it might cause some discomfort, such as nausea, it is a common procedure in neurological tests. Studies indicate that it usually leads to expected physical responses, such as eye movements, in individuals with normal inner ear balance. Overall, it is well-tolerated, though some temporary side effects may occur. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about caloric vestibular stimulation for OCD because it offers a novel approach by utilizing the body's vestibular system, which helps control balance and spatial orientation. Unlike standard OCD treatments like SSRIs or cognitive-behavioral therapy, this method involves a non-invasive procedure where cold water is gently infused into the ear canal. This technique potentially modulates brain activity related to OCD symptoms, providing a fast, drug-free alternative with minimal side effects. By targeting the brain's response mechanisms directly, it could lead to quicker symptom relief compared to traditional therapies.

What evidence suggests that caloric vestibular stimulation is effective for OCD?

Research has shown that caloric vestibular stimulation (CVS) can affect brain areas linked to awareness and perception. Early findings suggest CVS might aid people with obsessive-compulsive disorder (OCD) by enhancing their understanding of the condition. In this trial, participants will receive either left or right cold caloric vestibular stimulation, which involves placing cold water in the ear to influence balance and brain activity. This technique has shown promise in reducing symptoms and increasing awareness in related mental health issues. Although more research is needed, these early results are encouraging for those seeking new ways to manage OCD symptoms. ^{1 2 5 6 7}

Who Is on the Research Team?

Peter van Roessel, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with certain mental health disorders, including Obsessive-Compulsive Disorder, Body Dysmorphic Disorder, Illness Anxiety Disorder, or Somatic Symptom Disorder (excluding "with predominant pain").

No recent change in psychopharmacological treatment, if any

Age 18-65

Exclusion Criteria

You are currently pregnant or breastfeeding.

You are currently using or have recently used drugs or alcohol.

You have a medical or psychiatric condition, such as vertigo or a history of ear surgery, that could make it unsafe for you to take part in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive unilateral caloric vestibular stimulation with before and after measures of OCRD symptom severity and insight

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for changes in clinical insight using the Brown Assessment of Beliefs Scale

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Caloric Vestibular Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: right cold caloric vestibular stimulation Experimental Treatment 1 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 stimulation Experimental Treatment 1 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.

Caloric Vestibular Stimulation is already approved in European Union, United States for the following indications:

Approved in European Union as Caloric Vestibular Stimulation for:

• Diagnostic tool for vestibular function
• Temporary relief of phantom limb pain
• Management of motor and non-motor symptoms in Parkinson’s disease

Approved in United States as Caloric Vestibular Stimulation for:

• Diagnostic tool for vestibular function
• Temporary relief of phantom limb pain
• Management of motor and non-motor symptoms in Parkinson’s disease

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

The study analyzed caloric responses from 2587 patients, identifying significant differences in response magnitudes between warm and cool water stimuli, with warm water eliciting stronger responses.

Both air and water stimuli can effectively distinguish between normal vestibular function and bilateral vestibular weakness, achieving high sensitivity and specificity (0.82 to 0.84), suggesting that air caloric tests can be a reliable alternative to water tests when properly calibrated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of water and air caloric responses and their ability to distinguish between patients with normal and impaired ears. Zapala, DA., Olsholt, KF., Lundy, LB.[2008]

The newly developed air caloric stimulus protocol for vestibular testing uses temperatures of 30 and 44 degrees Celsius, which helps reduce discomfort for subjects while providing effective testing.

Data from 16 normal subjects indicate that the air caloric responses are equivalent to those obtained from the standard water caloric protocol, suggesting that air can be a viable alternative for vestibular testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for the air caloric test and a comparison with a standard water caloric test. Tole, JR.[2019]

The air caloric test, which uses air instead of water, is better tolerated by children and can be effectively used to evaluate vestibular function, showing significant differences in results compared to the traditional water test.

In a study of 27 children aged 5 to 14, the air test produced a lower maximum slow speed component (2.98 degrees/s) compared to the water test (4.74 degrees/s), indicating that while the two methods differ, the air test is a viable alternative for assessing labyrinthine function in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between air and water caloric tests in children. Melagrana, A., D'Agostino, R., Ravera, B., et al.[2019]

Evaluating hot and cold caloric tests separately in vestibular testing revealed that both tests could miss a significant number of cases with important differences in reflexivity or directional preponderance (DP).

The study suggests that using either the hot or cold caloric test as a screening technique could lead to missing over 75% of cases that require complete examination, indicating that both tests are equally important for accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a screening-procedure by hot-water caloric tests. Norré, ME.[2009]

Caloric stimulation is an effective clinical test for assessing vestibular function in neonates, particularly useful for identifying vestibular disorders in infants with sensorineural hearing loss, which affects 20% to 70% of this population.

In a study of 58 high-risk infants aged 3 to 6 months, about 34% showed a weaker nystagmic reaction to cold water compared to healthy controls, especially those with perinatal issues or congenital defects, highlighting the need for careful testing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Caloric stimulation in infants]. Zagólski, O.[2006]

In a study of 250 patients and 35 controls, the video head impulse test demonstrated low sensitivity (51%) and specificity (50%) in detecting post-caloric vestibular recruitment, indicating it may not be a reliable predictor for this condition.

The study found no significant differences in vestibular responses between the study and control groups, suggesting that factors like age and sex do not influence the outcomes of vestibular recruitment assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What does the video head impulse test tell us about post-caloric vestibular recruitment? Mezzalira, R., Bittar, RSM.[2023]

In a study of 49 patients (39 with peripheral vestibular disorders and 10 with acoustic neuroma), the vestibular autorotation test provided critical insights that were not captured by traditional caloric testing, particularly in patients with reduced vestibular responses.

The results indicated that while some patients with equal caloric responses had normal autorotation test results, those with significant vestibular response reductions consistently showed abnormal autorotation results, highlighting the importance of using both tests for a comprehensive assessment of vestibular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of vestibular autorotation and caloric testing. Saadat, D., O'Leary, DP., Pulec, JL., et al.[2017]

Citations

1. withpower.com withpower.com/trial/phase-body-dysmorphic-disorders-7-2021-d5812

Caloric Vestibular Stimulation for OCD Caloric stimulation is an effective clinical test for assessing vestibular function in neonates, particularly useful for identifying vestibular disorders in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03918577

Caloric Vestibular Stimulation for Modulation of Insight in ... Study Overview. This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X11000283

Beneficial effects of caloric vestibular stimulation on denial ... Original Article. Beneficial effects of caloric vestibular stimulation on denial of illness and manic delusions in schizoaffective disorder: A case report.

4. cambridge.org cambridge.org/core/journals/acta-neuropsychiatrica/article/studies-of-caloric-vestibular-stimulation-implications-for-the-cognitive-neurosciences-the-clinical-neurosciences-and-neurophilosophy/E43F3024FB6A5D728C8815C6586C04E0

Studies of caloric vestibular stimulation: implications for the ... Caloric vestibular stimulation (CVS) has traditionally been used as a tool for neurological diagnosis. More recently, however, it has been ...

5. ctv.veeva.com ctv.veeva.com/study/caloric-vestibular-stimulation-for-modulation-of-insight-in-obsessive-compulsive-spectrum-disorders

Caloric Vestibular Stimulation for Modulation of Insight in ... This study investigates whether caloric vestibular stimulation can modulate a measure of insight in obsessive-compulsive spectrum disorders.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557481/

Caloric Reflex Test - StatPearls - NCBI Bookshelf The caloric reflex test is an invaluable tool to assist in identifying any generalized or localized brainstem disorder and help in assessing the prognosis.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK448103/

Caloric Testing - StatPearls - NCBI Bookshelf Caloric stimulation (using warm or cold water or air) induces a predictable nystagmus response in individuals with normal vestibular function.