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临床试验/NCT07374640
NCT07374640尚未招募1 期

Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
12
试验地点
1
主要终点
Dizziness Handicap Inventory

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Virtual Reality (Device)

结局指标

主要结局

Dizziness Handicap Inventory

时间窗: 1 year

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.

Pediatric Quality of Life Inventory

时间窗: 1 year

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.

Fear of Pain Questionnaire

时间窗: 1 year

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.

Nijmegen Questionnaire

时间窗: 1 year

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.

Niigata PPPD Questionnaire

时间窗: 1 year

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.

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

时间窗: 1 year

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.

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

时间窗: 1 year

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.

次要结局

  • 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)
  • Electrodermal Activity (Skin Conductance)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Brodsky

Director, Balance & Vestibular Program

Boston Children's Hospital

研究点 (1)

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