Biofeedback Training for Hemianopia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Biofeedback training.
- Кому может быть актуально
- Состояния в реестре: Hemianopia, Brain Injuries. Базовые параметры: 18 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
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Официальное название
Biofeedback Training to Improve Fixation Stability, Visual Function Outcomes, and Quality of Life in Hemianopia Cases
Обзор
This is a prospective study that compares biofeedback training on the microperimetry (BT) to a control group in patient s with hemianopia. The patients receive 5 sessions of 20 minutes to stimulate with light and sound the brain in using the best residual area on the visual fields post-brain injury visual loss. Visual tests and quality of life questionnaire are performed pre-and-post-training.
Подробное описание
Background
Patients with brain injury secondary to stroke, surgery, or trauma frequently suffer from homonymous hemianopia, defined as vision loss in one hemi-field secondary to retro- chiasma lesion. About 45% of stroke survivors have homonymous hemianopia. A deficit in vision and spatial perception can cause slowdown of the rehabilitation progress in physiotherapy.
Patients face three main visual behavioural problems: (1) impaired eye movements (including saccades) leading to defective visual and spatial exploration, (2) reading deficit ( alexia) because of the para foveal field loss and (3) deviated subjective midline. Dyslexia is not simply the product of the visual field defect but is caused by a disorder of control of visual information processing and eye movements in reading.
Most importantly, the capability to read is fundamental for daily living and an essential prerequisite for education and success in our modern society, so this disorder can have a profound effect on patients' lives. Patients with visual field loss usually fail to adapt to their reading impairment (80% of cases). In these cases, word identification and the abilities to plan and guide reading eye movements are disturbed.
In spite of these facts, visual rehabilitation program on a larger scale is still missing in most rehabilitation centers and clinics. This is decurrent to the generalized belief that lesions of the lateral geniculate nucleus and striate cortex lead to a permanent loss of vision. According to scientific findings, this does not always have to be true.
Optical solutions have shown to be effective in helping visual impairments in hemianopia cases. Relatively small prismatic amounts may be tested and prescribed to this group, as the function of yoked prisms in these cases is to reduce the mismatch between their veridical objective and anomalous subjective sense of straight ahead to a perceptually acceptable level. Yoked prisms have been used by neuro rehabilitative optometrists for decades, as well as others in the field such as occupational therapists, to improve ambulation and gait in hemianopia and/or hemiplegia. Approximately two-thirds of the patients may respond favourably to the yoked prisms. Statements such as 'the visual space seems expanded', and observations such as having improved mobility, ambulation and eye-hand co-ordination, are positive prognostic indicators when prescribing yoked prisms in this diagnostic group.2 Likewise, it was demonstrated that application of yoked prisms improved balance and posture. 'Improved posture, and the sense of feeling more stable while walking through the environment', as well as marked, absence of 'feeling of nausea and dizziness while walking' or 'objects to appear to move when walking'.
Bi temporal visual field impairment frequently leads to binocular vision difficulties. Patients with bi temporal hemianopia with pre-existing strabismus complain of horizontal diplopia, sometimes combined with vertical deviation (with pre-existing). The symptoms are a result of the decompensation into a tropia (slide) due to the lack of retinal correspondence between the remaining nasal fields of both eyes. Aligning the eyes with prisms can prevent diplopia if the bi temporal hemianopia is incomplete.
Classic and effective saccadic compensatory training therapies are current. They aim to reorganize the control of visual information processing and eye movements or, in other words, to induce or improve oculomotor adaptation to visual field loss. Such therapies involve the systematic and repetitive practice of specific eye movements for reading or for visual exploration. Patients learn to intentionally shift their eyes and, thus, their visual field border, into the area corresponding to their blind visual field. This shift brings the visual information from the blind field into the seeing field for further processing. Patients learn, therefore, to efficiently use their eyes "to keep the 'blind side' in sight". The training-induced, efficient oculomotor adaptation to visual field loss becomes manifest as a change of reading (or visual exploration) eye-movement patterns and indicates the functional reorganization of the control of visual information processing and eye movements.
Biofeedback training for active eye movement control was never used in hemianopia cases before. Biofeedback training (BT) is the latest and newest technique for oculomotor control training in cases with low vision when using available modules in the new instruments. Studies in the literature highlighted positive benefits from using BT in a variety of central vision loss, nystagmus cases, and others. The purpose of this study is to assess systematically the impact of BT in a series of cases with hemianopia and formulate guidelines for further use of this intervention in vision rehabilitation of hemianopia cases in general.
Rationale for the study
The deviation of the subjective midline in hemianopia cases brings visual perception from a line of objects in the surrounds to be at a much higher-level of perception/cognition, thus disturbing reading, gait and balance. Besides that, impaired saccades also cause wrong exploration patterns and deteriorated visual search. It results in the prolonged exploration time of a scene and can lead to significant problems in daily life such as inability to navigate around various obstacles (cars, people and other objects). It also causes a cognitive deficit while extracting information from a visual scene. A combination of factors such as reduced contrast sensitivity, impaired visual search and inaccurate fixation contributes to the matter.
Visual information extraction from the para foveal visual field provides the basis for planning and guiding of reading eye movements. Therefore, patients with hemianopia have difficulties in shifting their gaze systematically from left to right (in right-sided field loss) or finding the beginning of a new line (in left sided field loss). Such eye movements are optimized by visual feedback. BT promotes luminous and auditory biofeedback, which increases its efficacy in vision rehabilitation.
BT provides the accurate and efficient oculomotor training necessary to relocate the subjective midline to the seeing field in 1 or even more, as needed. BT also improves dramatically fixation stability and saccades. The advantage of this training method over classic training is potentially great. Firstly, the highest retinal sensitivity convenient point can be identified considering the whole visual field. The device provides real time scrutiny of ocular movements on a screen, and the therapist is able to select precisely the trained retinal locus (FFT) to be used by the patient on top of the visual field. Finally, according to the patients' response the FFT can be readjusted. Eight cases trained with BT for hemianopia in our low vision rehabilitation (LVR) service had marked improvements in fixation stability, and micro perimeter fields.
Expansion of visual space in the direction of the blind field and compression of visual space in the direction of the seeing field may be a contributory factor to the altered perception of their egocentric directional sense and overall more veridical mapping of their visual space, as well as the resultant shift in their positional centre of gravity. We hypothesize that BT promotes this field relocation.
Conventional visual exploration training studies have confirmed that 10 to 25 training sessions in a 6-week period can be effective for hemianopia patients to adopt these strategies. BT is able to achieve significant results in 5 weekly sessions of 20 minutes each, according to 8 cases treated in our service.
Study hypothesis
The visual and audio parts of the BT program improve in a synergistic way oculomotor control through attention improvement and volitional eye movements towards pre-designated targets. Improved oculomotor control results in better fixation stability of eyes. Better fixation stability in turn results in better navigation for distance and near vision reading. Dual sensory BT is a therapy used in low vision for more than ten years, showing good results for near and distance vision in cases with macular degeneration and other pathologies. The study hypothesis, never tested before, is that BT in cases with hemianopia will positively impact oculomotor control and visual acuity as it was proven to do in cases with macular degeneration.
Significance of the study
Vision is a major sensory input to the human brain. Half of the afferent neuronal axons projecting to the brain originate from the eyes. Intact visual abilities are an important condition enabling us to orient ourselves in our world. It was reported that 50% of all neurological admissions into hospitals in the United Kingdom are due to a stroke and 30% percent of them are reported to have hemianopia.
Numbers of patients reported in the Czech Republic are similar and somewhat lower due to differences in diagnostics and classification of nosological units. Visual impairments are present in 20 to 40% of patients in neurological rehabilitation centres.
If brain visual plasticity is possible to be achieved from conventional vision training methods, specialized training with BT needs to be investigated as a tool for improving a cortical visual disorder. There is a need for simple and more effective visual training which could be used in LVR in large scale for hemianopia cases. Furthermore, BT needs to be evaluated in terms of quality of life (QoL) improvement to the patients.
Clinical trial design
This is a prospective clinical randomized trial to include a control group and take place over a period of up to 24 months. 35 patients will be randomized to the treated group (BT) and 35 patients to the control group.
The objectives set for this trial is to verify if BT impacts on oculomotor control in cases with hemianopia and results in better fixation stability, reading speed and QoL in those trained with BT.
Primary endpoints selected for this trial are retinal sensitivity, fixation stability (FS) estimates as tested with the Micro perimetry, Humphrey Full Field 120 perimetry (Carl Zeiss, Germany), reading speed as tested with the reading speed test, and QoL assessed with the 48 questions LVR questionnaire.
Secondary endpoints are preferred retinal locus (PRL) topographic coordinates, as tested with the Micro perimeter, contrast sensitivity measured with the charts, and Best Corrected Visual Acuity (BCVA) scores for distance and near vision tested with ETDRS charts at 4 meters and 33 cm.
Clinical trial population:
The intended population for this clinical trial is to be found among our own practice patients or among patients referred to our low vision rehabilitation practice. We will consider inclusion into the trial patients that meet the trial entry criteria defined below.
Inclusion criteria: hemianopia cases with more than 6 months from the date of the lesion, previously diagnosed accordingly by micro perimetry and other tests as needed, 18-90 years old, ability to follow the visual and auditory stimuli and training instructions.
Exclusion criteria: previous or current treatment for low vision rehabilitation, ocular diseases, other serious clinical conditions not related to the hemianopia, both eyes with media opacity that impairs micro perimetry testing, lack of ability to perform the tests and training.
Clinical trial procedures All parties involved in the conduct of this clinical trial will be qualified by education, training, or experience to perform their tasks, and this training will be documented appropriately. The investigation will not commence after receiving written approval from the ethics board of the University Health Network. All trial staff will be required to undergo training prior to performing any trial-related activities.
The following is an overview of the study procedures:
Вмешательства
- Поведенческое Biofeedback training
This is an audio-luminous stimulation on the micro perimeter that teaches the brain to use a different fixation locus on the retinal other than the fovea and develops visual attention to the surrounding retinal areas. 20 minutes exercises for stimulation are performed on the micro perimeter, once a week, for 5 weeks.
Первичные конечные точки
- Retinal sensitivity [Срок оценки: Pre- intervention and 1 month post-intervention.]
Вторичные конечные точки (6)
- Quality of Life Self Referred Score [Срок оценки: Pre- intervention and 1 month post-intervention.]
- Reading Speed [Срок оценки: Pre- intervention and 1 month post-intervention.]
- Humphrey Perimetry [Срок оценки: Pre- intervention and 1 month post-intervention.]
- Best corrected visual acuity for distance and near [Срок оценки: Pre- intervention and 1 month post-intervention.]
- Fixation stability [Срок оценки: Pre- intervention and 1 month post-intervention.]
- Oculomotor function [Срок оценки: Pre- intervention and 1 month post-intervention.]
Критерии участия
Критерии включения
Hemianopia cases with more than 6 months from the date of the lesion, previously diagnosed accordingly by micro perimetry and other tests as needed, 18-90 years old, ability to follow the visual and auditory stimuli and training instructions.
Критерии исключения
Previous or current treatment for low vision rehabilitation, ocular diseases, other serious clinical conditions not related to the hemianopia, both eyes with media opacity that impairs microperimetry testing, lack of ability to perform the tests and training.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- Toronto Western Hospital — Toronto
Идентификаторы
NCT: NCT06995313 · 20-5618