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临床试验/NCT04196933
NCT04196933撤回不适用

Temporal Synthesis of Vestibular and Extra-Vestibular Sensory Signals

Massachusetts Eye and Ear Infirmary1 个研究点 分布在 1 个国家目标入组 472 人开始时间: 2019年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
472
试验地点
1
主要终点
Changes in postural sway/balance

研究概览

简要总结

Multiple sensory cues are typically generated by discrete events, and while they do not reach the cerebrum simultaneously, the brain can bind them temporally if they are interpreted as corresponding to a single event. The temporal binding of vestibular and non-vestibular sensory cues is poorly understood and has not been studied in detail, despite the fact that the vestibular system operates in an inherently multimodal environment. In this study, the researchers are investigating the physiology and pathophysiology of vestibular temporal binding by studying normal subjects, patients with peripheral and central vestibular dysfunction, and patients with vestibular and cochlear signals provided by prosthetic implants in the inner ear.

详细描述

Multiple sensory cues are generated by discrete events (e.g., the vestibular-visual signals after hitting a pothole) and while they do not reach the cerebrum simultaneously, the brain can synthesize them if they are interpreted as corresponding to a single event. This is critical because the central representation of an event is improved if two or more relevant cues are integrated but conversely is degraded if unrelated inputs are synthesized. Little research has focused on temporal binding of vestibular signals with other sensory cues, even though the vestibular system operates in an inherently multimodal environment, and virtually nothing is known about temporal binding abnormalities in patients with peripheral or central vestibular disorders. The investigators will use psychophysical tests (quantifying the PSS [point of subjective simultaneity] and TBW [temporal binding window]) to study vestibular temporal binding in normal people, patients with combined vestibular and cochlear prostheses, and patients with peripheral or central vestibular dysfunction. The researchers will investigate two fundamental aspects of temporal binding: its dependence on signal precision and adaptation driven by habitual exposure to sensory patterns. Furthermore, the researchers will investigate how and why temporal binding differs from normal in patients with peripheral and central vestibular dysfunction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal subjects
  • •normal vestibular-oculomotor exams
  • •normal low-frequency standard rotational testing
  • •normal hearing
  • •meets International Headache Society (IHS) criteria for migraine with or without aura
  • •tested more than 2 weeks after most recent migraine headache
  • •Vestibular Migraine
  • •meets Barany Society criteria for vestibular migraine, which includes:
  • •episodic vestibular symptoms that occur with headaches that meet the IHS criteria for migraine
  • •tested more than 2 weeks after most recent migraine headache or vestibular episode
  • •Vestibular Schwannoma
  • •existence of unilateral vestibular schwannoma (pre & post clinical intervention e.g. surgical resection)
  • •must plan to have clinical intervention such as sub-occipital surgical approach with complete sectioning of the vestibular nerve
  • •rotational testing to assess pre-surgical vestibular function
  • •audiogram
  • •brain MRI consistent with vestibular schwannoma
  • •audiography in each ear
  • •Vestibular (VI) and Cochlear (CI) Implant subjects
  • •scheduled for CI surgery because of deafness
  • •minimum 5 year history of documented absence of auditory and vestibular function, based on review of their audiograms and vestibular tests
  • •specific vestibular criteria: peak ice water caloric response of less than 3deg/s for each ear; yaw VOR time constant <3s and gain <0.25; and reduced head impulse gain (<0.25) for all canal planes
  • •specific audiographic criteria: 80dB or greater sensorineural hearing loss in both ears

排除标准

  • •Normal subjects
  • •history of otologic or neurologic disease
  • •on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
  • •pregnant or recently (<6mos) pregnant
  • •history of vestibular symptoms (other than motion sickness)
  • •evidence of other neurologic or otologic dysfunction
  • •on migraine prophylactic medications
  • •on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
  • •Vestibular Migraine (VM)
  • •other neurologic or otologic dysfunction as defined above except for central eye movement findings that are consistent with VM and therefore not exclusionary.
  • •on migraine prophylactic medication
  • •on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
  • •Vestibular Schwannoma
  • •other otologic disease (other than presbycusis) or any neurologic disease (other than migraine)
  • •on vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)

研究组 & 干预措施

Normal Controls

No Intervention

normal control subjects - no history of neurologic or inner ear disease

The investigators will characterize vestibular spatial and temporal precision by calculating perceptual thresholds for vestibular (yaw rotation) stimuli in normal subjects over a wide age range. Vestibular-visual temporal binding is then performed on each subject and the relationship between the principal parameters (vestibular perceptual thresholds [inversely related to spatial precision] and the PSS and TBW from the temporal binding paradigm) will be examined. The investigators will collect qualitative assessments of dizziness/disbalance (DHI: dizziness handicap index) and quantitative measurements of balance and vestibular function (FGA: functional gait analysis, postural sway, and standard rotational testing - VOR gain, time constant, asymmetry).

Central Vestibular Dysfunction

No Intervention

Migraine and Vestibular Migraine patients

The investigators intend to evaluate vestibular (yaw rotation) - visual temporal binding in people with a wide range of motion sickness sensitivities (as quantified with standard questionnaires), including normal subjects, people with migraine and with vestibular migraine.

Peripheral Vestibular Dysfunction

No Intervention

Vestibular Schwannoma patients

The basic approach is to characterize the precision of their vestibular information (i.e., perceptual thresholds for spatial precision), and their temporal binding characteristics for vestibular (yaw rotation)-visual inputs, in three states: pre-op, sub-acute post-op (2-6 weeks), and chronic post-op (6 months+). At each state the investigators will also assess the quality of their vestibular-mediated behaviors through questionnaires (e.g. DHI), postural sway, functional gait analysis, and standard rotational testing (VOR gain, time constant, and asymmetry).

Implant Subjects

Experimental

Cochlear Implant (CI)/Vestibular Implant (VI) patients

A causative role for vestibular precision in temporal binding will be investigated in the VI patients, since the noise characteristics of the vestibular channel will be varied and to determine how this affects thresholds and temporal binding. As part of a second aim, the investigators will use VI and CI prosthetic signals in patients who have never received them together to see how the brain process sensory cues to which it is essentially naïve. Finally, after the acute experiments the investigators will provide 8 hours of 'physiologic' VI and CI stimulation by turning both implants on, sound modulates activity in the CI as usual, and angular head motion modulates activity in the VI while the subject actively explores the hospital environment.

干预措施: Temporal Binding Adaptation - PSS adaptation with VI stimulation (Behavioral)

Implant Subjects

Experimental

Cochlear Implant (CI)/Vestibular Implant (VI) patients

A causative role for vestibular precision in temporal binding will be investigated in the VI patients, since the noise characteristics of the vestibular channel will be varied and to determine how this affects thresholds and temporal binding. As part of a second aim, the investigators will use VI and CI prosthetic signals in patients who have never received them together to see how the brain process sensory cues to which it is essentially naïve. Finally, after the acute experiments the investigators will provide 8 hours of 'physiologic' VI and CI stimulation by turning both implants on, sound modulates activity in the CI as usual, and angular head motion modulates activity in the VI while the subject actively explores the hospital environment.

干预措施: Chronic Motion-modulated Stimulation (Behavioral)

Post-op Vestibular Schwannoma patients

Experimental

Vestibular Schwannoma patients who are 6mos+ post-surgery (for removal of vestibular schwannoma, resulting in 8th nerve being cut & complete loss of peripheral vestibular signals from affected ear). While many post-op VS patients recover well, some continue to have persistent problems with balance and symptoms of dizziness. This study will explore how/whether PSS adaptation may improve vestibular clinical outcomes such as improved gait and dizziness symptoms following gait with horizontal (yaw) head motion.

干预措施: Temporal Binding Adaptation - PSS training (Behavioral)

结局指标

主要结局

Changes in postural sway/balance

时间窗: baseline and post-PSS adaptation (1 hour)

Measurements of postural sway during Romberg testing on floor and foam (including an extra 60s balance test during which subject stands on foam and shakes head left and right at 1hz frequency while fixating on a point a set distance away) pre \& post temporal binding adaptation (TBW \& PSS training).

Change in rapid measure of gait

时间窗: baseline and post-PSS adaptation (1 hour)

This measure is scored before and after PSS adaptation in UVD (unilateral vestibular dysfunction) patients. Gait is scored by performance on a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

Change in measure of inducible dizziness

时间窗: baseline and post-PSS adaptation (1 hour)

Looking at the change between before and after PSS adaptation in UVD (unilateral vestibular dysfunction) patients. Inducible dizziness is the symptom severity provoked by a task derived from the FGA (walking 40 feet while turning the head from side to side). It is scored on a 0 to 10 visual scale and provides a rapid assessment of vestibular function pre and post adaptation.

Change in Point of Subjective Simultaneity (PSS)

时间窗: baseline and 1 hour post 8-hour VI-CI 'physiologic' stimulation

Pre and post chronic motion-modulated stimulation in CI/VI patients - the PSS will be measured during temporal binding testing

次要结局

未报告次要终点

研究者

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

Richard Lewis

Associate Professor, Otolaryngology and Neurology; Director, Jenks Vestibular Laboratory

Massachusetts Eye and Ear Infirmary

研究点 (1)

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