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Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness

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Boston Children's Hospital

Status and phase

Begins enrollment this month
Early Phase 1

Conditions

Vestibular Migraine
Persistent Postural Perceptual Dizziness
Chronic Dizziness

Treatments

Device: Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT07374640
IRB-P00041413

Details and patient eligibility

About

Both persistent postural-perceptual dizziness (PPPD) and vestibular migraine (VM) are common diagnoses in patients presenting to physicians for evaluation of vestibular symptoms such as dizziness and vertigo. Although they are most often described in the adult population, they are also common in children and adolescents with dizziness. Chronic dizziness profoundly affects quality of life, often keeping children out of school and inhibiting their participation in the normal activities of childhood and adolescence. Overall, chronic dizziness is suspected to be due in large part to a "rewiring" of the brain that alters how cues related to balance and orientation are processed, with overreliance on visual inputs to maintain balance and equilibrium being a common development. Thus, chronic dizziness, especially that which is due to PPPD, is often caused by visual triggers.

A multi-modal approach is often taken to treat chronic dizziness, attempting to recalibrate this maladaptive "rewiring" and return the sensory system to normal function. Given the role that visual inputs play in developing and perpetuating chronic dizziness, habituation to visual stimuli should be a significant component to treatment. Treatments often include cognitive behavioral therapy (CBT), systematic desensitization exposure response prevention (SDERP), and biofeedback therapy (BFB). However, these visually provoked symptoms are often resistant to treatment. One reason for this may be that visual stimuli are difficult to replicate in the clinic or office. One way to address this gap in treatment is through virtual reality (VR) technology, which immerses patients in realistic visual environments.

VR has not been explicitly described in the treatment of PPPD or chronic dizziness, but it has been piloted, and shown to be effective, in the rehabilitation of peripheral vestibular dysfunction. This study aims to integrate VR into the current PPPD/chronic dizziness techniques of CBT, SDERP, and BFB. We will use a commercially available VR headset, which enables the use of VR in the office setting in a relatively low-cost form of VR technology. This study will evaluate the feasibility and effectiveness of VR in conjunction with CBT, SDERP, and BFB to investigate if VR technology enhances previously established effective treatments to reduce chronic dizziness and PPPD.

Full description

Persistent postural-perceptual dizziness (PPPD) is a chronic vestibular disorder characterized by dizziness, unsteadiness, or non-spinning vertigo exacerbated by position changes, active or passive motion, and complex or moving visual stimuli. PPPD was defined in 2017 as an addition to the International Classification of Vestibular Disorders and will be included in the next iteration of the International Classification of Diseases by the World Health Organization (ICD-11). It is a common diagnosis in patients presenting to tertiary centers for evaluation of vestibular symptoms. Although PPPD is most often described in the adult population, it is also common in children and adolescents with dizziness.

Vestibular migraine is the most common cause of episodic dizziness in children and adults. It can sometimes cause chronic, daily dizziness symptoms and can sometimes also trigger concurrent PPPD, which also causes chronic, daily dizziness.

The symptoms of chronic dizziness profoundly affect quality of life, often keeping children out of school. Moreover, most patients are symptomatic for many months or even years before receiving a diagnosis and initiating treatment. As PPPD is not likely to resolve spontaneously or without treatment, effective early treatment is crucial to alleviating symptom burden. Chronic vestibular migraine is typically treated primarily with medications, which can cause side effects and are sometimes inadequate to achieve complete symptom control.

PPPD is typically precipitated by an event that causes dizziness, vertigo, or unsteadiness, such as an acute or episodic peripheral vestibular disorder, concussion, psychological distress, or adverse medication effect. Though an utterly definitive model is still being established, it is widely accepted that PPPD may develop following these inciting events through the development and perpetuation of maladaptive compensatory strategies, such as overreliance on visual inputs to maintain equilibrium and balance, and heightened anxiety or body vigilance during self-motion or motion-rich environments. These responses to dizziness or unsteadiness are typically transient but become persistent and maladaptive in PPPD, leading to a "rewiring" of the brain that alters how cues related to balance and orientation are processed.

A multi-modal approach to chronic dizziness treatment is often taken to recalibrate maladaptive compensatory strategies and return the sensory system to normal function. One component of treatment includes cognitive behavioral therapy (CBT). The overall goals of CBT include reducing behaviors, thoughts, feelings, and symptoms that perpetuate chronic dizziness, particularly avoidance of environments that provoke dizziness, dependence on the visual system, and excessive monitoring of bodily sensations. Patients develop alternative strategies for responding to symptoms of dizziness or unsteadiness, such as relaxation or distraction techniques. With systematic desensitization exposure response prevention (SDERP) treatment, gradual exposure to provocative environments is essential, enabling patients to habituate to, rather than avoid, symptoms.

Biofeedback (BFB) therapy is a noninvasive intervention through which individuals receive information on their physiological responses and learn to modify them actively. For example, Heart rate variability (HRV) BFB has recently been shown to be an effective intervention for a variety of psychophysiological disorders. The goal of BFB is for patients to gain a strong understanding of their physiological responses to environments around them and leverage that knowledge to lessen the severity and frequency of symptoms.

Given the vital role that visual inputs play in developing and perpetuating chronic dizziness, habituation to visual stimuli must be a significant component of treatment. However, visually provoked symptoms, rather than motion or position-provoked symptoms, are often the most resistant to current treatment options. One cause may be that visual stimuli are difficult to replicate in the clinic or office. As a result, using SDERP with a fear of symptom hierarchy in these visually stimulating environments cannot be fully addressed in these controlled treatment settings. One way to address this treatment gap is through virtual reality (VR) technology. VR immerses patients in realistic visual environments, making the exposure (in vivo) in real time a valuable adjunct to treatment.

Although VR has not been explicitly described in the treatment of PPPD, it has been piloted in the rehabilitation of peripheral vestibular dysfunction. These studies often employed large virtual reality theaters with multiple projected screens, and participants performed exercises while immersed in the environment. Preliminary studies have shown these VR interventions to be effective, particularly in reducing the severity of visually induced symptoms. Therefore, the current study hypothesizes that integrating VR into current PPPD treatment techniques - specifically BFB, SDERP, and CBT - may benefit patients and further strengthen the effectiveness of these methodologies. We will use a commercially available VR headset, which will enable the use of VR in the office setting and is a relatively low-cost form of VR technology. This study aims to evaluate the feasibility and effectiveness of VR in conjunction with BFB, SDERP, and CBT to investigate if VR technology will enhance the known effective treatments to reduce dizziness as a treatment approach to PPPD and other forms of chronic dizziness.

Enrollment

12 estimated patients

Sex

All

Ages

13 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- Patients who previously or are currently seen in our program who have not already undergone BFB, CBT, and SDERP for treatment of their chronic dizziness.

Exclusion criteria

  • Patients without chronic dizziness.
  • Patients for whom written consent is not available.
  • Patients who exhibit psychotic features, have untreated mental health conditions, or have an intellectual disability, developmental delay, or decisional impairment.
  • Non-English language preference patients.
  • Patients with a history of seizures, at risk of seizures, or who have a diagnosis of epilepsy.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

VR in conjunction with BFB, SDERP, and CBT
Experimental group
Description:
This group will undergo virtual reality exercises in conjunction with the standard-of-care biofeedback, systematic desensitization exposure response prevention, and cognitive behavioral therapy.
Treatment:
Device: Virtual Reality

Trial contacts and locations

1

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Central trial contact

Kyle K Pandiscio, BS; Jacob R Brodsky, MD

Data sourced from clinicaltrials.gov

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