Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness

NCT07374640 | Not Yet Recruiting Early Phase 1 FDA Device

• 1 other identifier: IRB-P00041413
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Postural Perceptual Dizziness; Vestibular Migraine; Chronic Dizziness

Keywords

Persistent Postural-Perceptual Dizziness; Vestibular Migraine; Chronic Dizziness; Virtual Reality; Biofeedback

Outcome Measures

Primary Outcomes (7)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure

  An 8-item self-report measure that screens for an quantifies the severity of anxiety symptoms. Participants rate the frequency of each item within the past seven days on a 5-point Likert scale (1-Never; 5-Almost always). A higher score suggests a higher severity of anxiety.

  1 year

• Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Measure

  An 8-item self-report measure that screens for and quantifies the severity of depression symptoms. Participants rate the frequency of each item within the past seven days on a 5-point Likert scale (1-Never; 5-Always). Higher score suggests a higher severity of depression.

  1 year

• Niigata PPPD Questionnaire

  A 12-item self-reported measure intended to assess symptom severity, specifically for PPPD. Participants rate how much eat item has affected them in the past week on a 7-point Likert scale (0-None; 6-Unbearable). Scores range from 0 to 72, with higher scores indicating greater symptom severity.

  1 year

Secondary Outcomes (6)

• Ratings of dizziness and pain severity, duration, and frequency

  1 year

• Degree of stress before, during, and after exposure to virtual environments

  1 year

• Degree of symptoms before, during, and after exposure to virtual environments

  1 year

• Heart Rate Variability

  1 year

• Respiratory Rate

  1 year

Study Arms (1)

VR in conjunction with BFB, SDERP, and CBT

EXPERIMENTAL

This group will undergo virtual reality exercises in conjunction with the standard-of-care biofeedback, systematic desensitization exposure response prevention, and cognitive behavioral therapy.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Application 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.

Also known as: VR

VR in conjunction with BFB, SDERP, and CBT

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital at Waltham

Waltham, Massachusetts, 02453, United States

Location

Related Publications (27)

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Related Links

• Related Info

Study Officials

• Jacob R Brodsky, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob R Brodsky, MD

CONTACT

781-216-2849; jacob.brodsky@childrens.harvard.edu

Kyle K Pandiscio, BS

CONTACT

781-216-1633; kyle.pandiscio@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Balance & Vestibular Program

Model Details: This is a pilot study evaluating the feasibility and effectiveness of VR as an addition to the standard-of-care treatments of BFB, SDERP, and CBT for treating chronic dizziness and PPPD in adolescents.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)