Caloric Vestibular Stimulation for OCD
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Vertigo, Otological surgery, Substance use, others
No Placebo Group
Approved in 2 Jurisdictions
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.12345
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.23467
Research Team
PJ
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
See 2 more
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.
Trial 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 (Other)
Trial OverviewThe 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
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Trials
2527
Patients Recruited
17,430,000+
References
Comparison between air and water caloric tests in children. [2019]The caloric test represents an essential part of each procedure evaluating vestibular function. The use of water has many contraindications: tympanic perforation, external otitis and mastoid diseases. Sometimes, nausea can make test execution very difficult. Several authors contributed to the study and diffusion of the caloric test for the evaluation of labyrinthine function using different types of otoalcorimeters. We compared two methods in the child--generally intolerant to the water test--and the results obtained were adapted to a mathematical model of air and water caloric nystagmus. Twenty-seven normal children, aged between 5 and 14 years, subdivided into three age groups (5-7, 8-10 and 11-14 years), underwent the water caloric test (250 cm3 at 31 and 43 degrees C for 40 s) and then the air test, together with another nine subjects undergoing only the air test (flow-rate 8 l/min at 25 and 49 degrees C) on different days. The comparison between the two stimulation methods showed a statistically significant difference (P
[Caloric stimulation in infants]. [2006]Caloric stimulation is one of few clinically proven tests assessing the function of each vestibule separately in neonates. Its results represent the continuity of vestibulo-ocular reflex, beginning in the lateral vestibular canal. Vestibular disorders are diagnosed in 20 to even 70% neonates with sensorineural hearing loss with the prevalence of individuals with profound and acquired deafness. 58 high risk of hearing defect infants were included in the study. Their age ranged from 3 to 6 months. A group of 27 healthy controls with negative history concerning sensorineural hearing loss risk factors was also examined. Caloric stimulation was performed according to Veits. External ear canal was irrigated with 20 ml of water at the temperature of 20 degrees C and eye movements were watched indirectly. In about 34% infants the nystagmic reaction to cold water was weaker than in normal controls. The reaction was most frequently impaired in infants with perinatal pathology, multiple congenital defects and aminoglycoside administration. Caloric stimulation in infants should be performed with cold water and the syringe used in the test should be fitted with a soft hose enabling irrigation of the interior part of the external ear canal.
A comparison of water and air caloric responses and their ability to distinguish between patients with normal and impaired ears. [2008]The caloric test is a mainstay of modern vestibular assessment. Yet caloric test methods have not been well standardized, and normal response values have not been universally agreed upon. The air caloric test has been particularly problematic. In this article, we present our efforts to establish a population-based description of the caloric response evoked by water and air stimuli at both cool and warm temperatures.
What does the video head impulse test tell us about post-caloric vestibular recruitment? [2023]The vestibular recruitment observed in caloric testing is a new tool in the study of the vestibulo-ocular reflex. This study aimed to determine the sensitivity and specificity of the video head impulse test to detect post-caloric vestibular recruitment.
A protocol for the air caloric test and a comparison with a standard water caloric test. [2019]This communication describes the development of a protocol for the air caloric stimulus for vestibular testing. The protocol is based on matching the peak responses of air and water caloric stimuli and minimizing subject discomfort. Air stimulus temperatures of 30 and 44 degrees C are used, and these appear to minimize subject complaints of pain with the test. Composite data are presented from 16 normal subjects who were tested with the protocol. A comparison is made with their responses to a standard water protocol. Test-retest data for both air and water protocols are also presented, and these data indicate similar day-to-day variation in the two methods. On the basis of the work presented, it is concluded that the air protocol produces responses equivalent to that of standard water calorics in a group of normal subjects. Neither test was found, in the present experiments, to be particularly sensitive.
Comparison of vestibular autorotation and caloric testing. [2017]The two most common stimuli of the vestibular system for diagnostic purposes are caloric and rotational head movements. Caloric stimulation, by delivering thermal energy to the lateral semicircular canal, is a well-studied method of vestibular testing, and its clinical usefulness has been established. Vestibular autorotation testing uses high-frequency (2 to 6 Hz), active head movements to stimulate the horizontal and vertical vestibulo-ocular reflex to produce measurable eye movements that can be used to calculate gain and phase. We compared the alternate bilateral bithermal caloric results with the vestibular autorotation test results obtained from 39 patients with peripheral vestibular disorders and from 10 patients with acoustic neuroma. In the peripheral disorder group, only 2 of 14 patients with equal caloric response (
Evaluation of a screening-procedure by hot-water caloric tests. [2009]In order to introduce a screening-procedure for vestibular caloric testing, we tried to evaluate the hot and cold caloric tests separately. We made a review of a series of cases having been tested by the classical 4 tests (cold and hot bilateral). In supposing that we should have stopped the investigation when the hot calorics showed a side-difference of 20% or more for the slow-phase velocity at the culminationpoint, we verified how many cases would have been missed, presenting by global examination a significant difference either for the reflexivity or for the DP. This study showed us that an important number of cases would have been missed equally well by the hot calorics as by the cold ones. The comparison shows no difference between them. By narrowing the criteria we would allow a screening-technique either by the cold or by the hotwater test, but in this way more than 3/4 of the cases were indicated for complete examination.