Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age13-25
SponsorBoston Children's Hospital
About this trial
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. The investigators 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality
DeviceApplication of a virtual reality headset and experience in a virtual realty environment in addition to the standard-of-care biofeedback, systematic desensitization exposure response prevention, and cognitive behavioral therapy.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: VR in conjunction with BFB, SDERP, and CBTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dizziness Handicap Inventory
A 25-item self-assessment that quantifies the impact of dizziness on daily functioning. The DHI measures self-perceived handicap due to dizziness in the functional, emotional, and physical domains. Higher score corresponds to a greater perceived handicap due to dizziness.
Time frame
1 year2
Nijmegen Questionnaire
A 16-item self-report questionnaire to assess hyperventilation syndrome. Participants are asked to rate the occurrence of 16 symptoms commonly associated with hyperventilation syndrome on a 5-point Likert scale (0-Never; 4-Very often). Scores range from 0 to 64, with higher score indicating worse outcome. A score greater than 23 suggests positive diagnosis of hyperventilation syndrome.
Time frame
1 year3
Pediatric Quality of Life Inventory
A 23-item inventory that measures health-related quality of life. The PedsQL consists of 4 scales: physical, emotional, social, school. Participants rate how often each item has been a problem for them within the past month on a 5-point Likert scale (0-Never; 4-Almost always). Higher score suggests lower health-related quality of life.
Time frame
1 year4
Fear of Pain Questionnaire
A 23 or 24-item (depending on self-report or parent-proxy version) questionnaire that assesses pain-related fears. Participants are asked to rate each item on a 5-point Likert scale (0-Strongly Disagree; 4-Strongly Agree). Higher score suggests a higher level of pain-related fears.
Time frame
1 yearSecondary outcomes
1
Ratings of dizziness and pain severity, duration, and frequency
Each patient will have a "Chronic Dizziness Log" that subjectively tracks self-reported dizziness and pain associated with PPPD, including severity, duration, and frequency. Participants will be asked to report each measure on a scale of 1-10. (1-Not present; 10-As bad as it can be).
Time frame
1 year2
Degree of stress before, during, and after exposure to virtual environments
When experiencing a virtual reality (VR) environment via the VR headset, participants will be asked to report their level of stress before entering the environment, while in the environment, and after the exposure is over. Participants will be asked to report their stress on a scale of 1-10 (1-Not present; 10-As bad as it can be).
Time frame
1 year3
Degree of symptoms before, during, and after exposure to virtual environments
Each participant will be asked to report both the duration and the severity of their symptoms before entering a virtual reality environment, while experiencing that environment, and after the virtual reality exposure is over. They will be asked to report these symptom measures on a scale of 1-10 (1-Not present; 10-As bad as it can be).
Time frame
1 year4
Heart Rate Variability
A core component of biofeedback (BFB) therapy, HRV is the variation in time between each cardiac cycle, measured by ECG leads placed on the wrists and hands. This BFB measure allows researchers to track participants' progress in BFB therapy over time. HRV is expected to increase with successful treatment.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov
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