視覚障害を持つ成人における方向感覚と移動能力に対する脳刺激効果のパイロット研究。

This within-subject crossover pilot study involves applying a weak focused electrical current to the head, to target areas of visual processing, more specifically the primary visual cortex (V1) within the occipital pole. The purpose of this study is to investigate the efficacy of high-frequency transcranial random noise stimulation (hf-tRNS), a safe and well-established form of brain stimulation on O&M performance of individuals with constricted visual fields in both eyes due to either retinitis pigmentosa (RP), rod-cone dystrophy, or advanced glaucoma.

Participants will be recruited from university-affiliated clinics as well as local clinical practices. After obtaining full informed consent at the first visit, participants will complete clinical tests to confirm that the eligibility criteria of the study are met. These tests include measuring the participant's corrected binocular distance and near visual acuities, binocular contrast sensitivity, binocularity, as well as peripheral visual fields. Researchers will also ensure that it safe for the participant to undergo brain stimulation using a list of contraindicators for brain stimulation interventions and verify that participants are free from physical or motor impairments as well as vestibular disorders or dysfunctions that can impact the participant's walking and balancing abilities.

During the two subsequent visits, the effects of stimulation (which lasts 20 minutes) will be studied 2 and 30 minutes after stimulation. To evaluate improvement, various measures of O&M performance will be targeted as participants complete an O&M course divided into 4 sections and composed of an array of static natural and artificial (man-made) obstacles. Participants will be instructed to walk along the various sections at a comfortable pace, safely negotiating the obstacles without touching any of the obstacles. Participants will also be told in which sections obstacles will be encounter. Static natural obstacles refer to fixed/steady/stable obstacles that are either readily found in the environment (e.g., potted plants) or form part of the architecture of the building (e.g., a pole or a sealed doorway). Artificial obstacles will be made of light material such as polystyrene, rubber foam, soft cardboard, burlap, light plastic, or paper. Static natural/real obstacles will be at foot level, foot to knee height, as well as shoulder and head heights, whereas artificial obstacles will be placed either above the knee, waist, at the shoulder or head height. Individuals with constricted field loss in both eyes who use a long white cane for travelling and have received O&M training (including caning skills) from an orientation and mobility professional will be asked to complete the course with their cane. However, individuals with constricted visual field in both eyes who do not use a cane can also complete the same course.

Measures of performance include the primary outcome measure percentage preferred walking speed (PPWS), that is the walking speed of the individual who is visually impaired in an environment with obstacles expressed as a percentage of their preferred walking speed in an unobstructed path. Secondary outcome measures include: the time taken to complete each of the 4 sections of the course, visual detection distance (VDD) (the distance at which an individual detects an obstacle in the travel path, even if it cannot be identified), and visual identification distance (VID) (the distance at which an individual can correctly identify an obstacle in the travel path).

Course section #1 will not consist of obstacles. The time taken to complete the course section, and preferred walking speed in an unobstructed path (obtained from the completion time and length of the straight, flat path) will be measured.

Course section #2 will consist of obstacles and will be an indoor space leading to a more opened space within the building. The time taken to complete the course section, and preferred walking speed in an obstructed path (obtained from the completion time and length of the path) will be measured. The percentage preferred walking speed (PPWS) will be calculated. PPWS is the preferred walking speed of the individual in course section #2 expressed as a percentage of the participant's preferred walking speed in course section #1.

Course sections #3 and #4 will be used for measuring VDD and VID. Each course will be a straight indoor corridor consisting of only one obstacle, and the obstacle will be different for each of the two sections. Moreover, course section #3 will be used as a training course for measuring VDD and VID. The time taken to complete the course section, visual detection distance (VDD), and visual identification distance (VID) will be measured in course sections #3 and #4.

It is important to note that for course section # 2, the location of the obstacles in each trial (pre, post 1, and post 2) will not be varied, but rather the location of the obstacles on each treatment day will be randomized. Moreover, given that courses 3 and 4 only have one obstacle each, it would also help to change what the actual object is for both courses for each trial on both treatment days, as well as the distance they are positioned. Therefore, with respect to courses 3 and 4, each participant will have to detect and hence identify a total of 12 single obstacles. In addition, two researchers will always be with the participant at all times. One will be with the participant to provide instructions and record data; whilst the other will be ahead of the participant to make sure the path is clear, record the times, and confirm that the obstacles are still in place (when applicable).

There will be two stimulation sessions (one with active stimulation and one with placebo (the order will be randomized so that neither the participant nor the researcher will know what the subject will receive)). At the two stimulation sessions the primary and secondary outcome measures will be evaluated as the participant completes the O&M course before stimulation (O&M pretest), as well as 2 mins after stimulation (O&M post-test 1/immediately after stimulation), and 30 mins after stimulation (O&M post-test 2/30 minutes after stimulation).

We hypothesize that the application of hf-tRNS to V1 will improve the orientation and mobility skills of individuals with constricted visual fields immediately following stimulation as a results of enhanced periphery through modulation of the mechanisms responsible for crowding, thereby reducing crowding effects and improving contrast for individuals with rod-cone dystrophy and RP (genetic conditions),whereas for individuals with glaucoma (a neurogenerative condition) who have little to no functional peripheral vision, any improvement noted would be attributed to be enhanced processing of visual signal in the affected periphery. The objective of this study is to improve the fundamental visual processes of individuals with constricted visual fields using hf-tRNS. From a scientific perspective, the investigators hope to discover whether brain stimulation can serve as an additional rehabilitation tool for improving the O&M skills of individuals with constricted visual fields. Investigators expect that participants will experience temporary O&M improvements, however, there will not be any lasting improvements in O&M skills from such a single session within subject study design. If the results of this study show a positive effect, the data will be used to power a larger study. All procedures will occur at the Human Visual Neuroscience Laboratory, University of Waterloo, Ontario, Canada.