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

Trial Summary

What is the purpose of this trial?

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.

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.

Is caloric vestibular stimulation safe for humans?

Caloric vestibular stimulation, using either water or air, is generally safe for humans, but it can cause discomfort such as nausea and should be avoided in cases of ear infections or perforated eardrums. Studies have shown it is used safely in both adults and children, although children may find the water test more uncomfortable. ^{1 2 3 4 5}

How is Caloric Vestibular Stimulation treatment different from other OCD treatments?

Caloric Vestibular Stimulation is unique because it involves using temperature changes in the ear canal to stimulate the vestibular system, which is different from typical OCD treatments that often involve medication or cognitive-behavioral therapy. This method is traditionally used to assess balance and hearing issues, making its application for OCD novel. ^{2 3 4 6 7}

Research Team

Peter van Roessel, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Comparison between air and water caloric tests in children. [2019]

2. Poland pubmed.ncbi.nlm.nih.gov

[Caloric stimulation in infants]. [2006]

3. United States 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. [2008]

4. Brazil pubmed.ncbi.nlm.nih.gov

What does the video head impulse test tell us about post-caloric vestibular recruitment? [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Comparison of vestibular autorotation and caloric testing. [2017]

7. Belgium pubmed.ncbi.nlm.nih.gov

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