Recruiting
Early Phase 1

VR with CBT, SDERP, BFB

Sponsor:

Boston Children's Hospital

Code:

NCT07374640

Conditions

Persistent Postural Perceptual Dizziness

Vestibular Migraine

Chronic Dizziness

Eligibility Criteria

Sex: All

Age: 13 - 25

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

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

Study ID

NCT07374640

Start date

Aug 3, 2026

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR in conjunction with BFB, SDERP, and CBT

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

Interventions

Virtual Reality

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.

Primary outcome measure

  • Dizziness Handicap Inventory [ Time Frame: 1 year ]
  • Nijmegen Questionnaire [ Time Frame: 1 year ]
  • Pediatric Quality of Life Inventory [ Time Frame: 1 year ]
  • Fear of Pain Questionnaire [ Time Frame: 1 year ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure [ Time Frame: 1 year ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Measure [ Time Frame: 1 year ]
  • Niigata PPPD Questionnaire [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Boston Children's Hospital at Waltham

Recruiting

Waltham, Massachusetts, United States, 02453

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

Oct 22, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.