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Recruiting EARLY_Phase 1 NCT07374640

NCT07374640 Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness

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Clinical Trial Summary
NCT ID NCT07374640
Status Recruiting
Phase EARLY_Phase 1
Sponsor Boston Children's Hospital
Condition Persistent Postural Perceptual Dizziness
Study Type INTERVENTIONAL
Enrollment 12 participants
Start Date 2026-08-03
Primary Completion 2027-03

Eligibility & Interventions

Sex All sexes
Min Age 13 Years
Max Age 25 Years
Study Type INTERVENTIONAL
Interventions
Virtual Reality

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 12 participants in total. It began in 2026-08-03 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Jacob R Brodsky, MD

✉ jacob.brodsky@childrens.harvard.edu

📞 781-216-2849

Principal Investigator

Jacob R Brodsky, MD

PRINCIPAL INVESTIGATOR

Boston Children's Hospital

Frequently Asked Questions

Who can join the NCT07374640 clinical trial?

This trial is open to participants of all sexes, aged 13 Years or older, up to 25 Years, studying Persistent Postural Perceptual Dizziness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07374640 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT07374640 currently recruiting?

Yes, NCT07374640 is actively recruiting participants. Contact the research team at jacob.brodsky@childrens.harvard.edu for enrollment information.

Where is the NCT07374640 trial being conducted?

This trial is being conducted at Waltham, United States.

Who is sponsoring the NCT07374640 clinical trial?

NCT07374640 is sponsored by Boston Children's Hospital. The principal investigator is Jacob R Brodsky, MD at Boston Children's Hospital. The trial plans to enroll 12 participants.

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