跳至主要内容
临床试验/NCT06578117
NCT06578117Enrolling By Invitation不适用

Statistical Learning as a Novel Intervention for Cortical Blindness

University of Rochester1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Explicit Learning - Response Time

研究概览

简要总结

This project aims to develop a novel visual training paradigm for use in visually-intact participants and those sufferings from stroke-induced visual impairments. Our task design is built upon theories of statistical learning to reduce the overall training burden while still producing profound improvements to visual abilities. Efficacy will be first established in visually-intact controls before testing in stroke survivors to assess the feasibility of this form of learning in the damaged visual system.

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
None

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cortically Blind participants
  • Inclusion criteria:
  • Between 21 and 75 years of age
  • Residents of the United States or Canada
  • Have successfully completed previous enrollment in Dr. Huxlin study (IRB #5966 or #75)
  • Exhibit unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans)
  • Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey visual fields. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
  • Able to fixate on visual targets reliably for 1000ms within 1-deg of visual angle.
  • Willing, able, and competent to provide their own informed consent
  • Normal cognitive abilities and be able to understand written and oral instructions in English

排除标准

  • Past or present ocular disease interfering with visual acuity
  • Best corrected visual acuity (BCVA) worse than 20/40 in either eye
  • Sustained documented or suspected damage to the dorsal Lateral Geniculate Nucleus
  • Presence of diffuse whole brain degenerative processes
  • History of traumatic brain injury
  • Any other brain damage deemed by study staff to potentially interfere with training ability or outcome measures
  • Documented history of drug/alcohol abuse
  • Currently taking neuroactive medications which would impact training, as determined by PI
  • Cognitive or seizure disorders
  • One-sided attentional neglect
  • Those who lack the competence or are otherwise unable to perform the visual training exercises as directed.
  • Control participants
  • Inclusion criteria:
  • Between 21 and 75 years of age
  • No history of neurological disorder.
  • Competent and responsible, as determined by the screening interview
  • Exclusion criteria:
  • Any damage to the visual system
  • Those who are suffering from an active disease process involving their nervous system.
  • Presence of cognitive or seizure disorders
  • Best corrected visual acuity worse than 20/40 in either eye
  • Presence of visual field loss from ocular disease or disorder

研究组 & 干预措施

Visual Training in Cortically Blind cohort

Experimental

干预措施: Vision Training and Learning Task (Device)

Visual Training in Control cohort

Experimental

干预措施: Vision Training and Learning Task (Device)

结局指标

主要结局

Explicit Learning - Response Time

时间窗: Baseline

Reaction time (ms) when performing motion discriminations for the final stimulus of a statistically-linked triplet will be compared against reaction times for stimuli with identical motion directions, presented with alternative placement within a triplet. Comparisons will be made only for correct responses in the final 20% of overall testing session trials.

Implicit Learning - Triplet Familiarity

时间窗: Baseline

Participant familiarity with statistically-linked triplets of motion will be assessed via a two-interval, forced-choice task. Familiarity will be measured as a percentage of comparisons in which the more prevalent triplet is selected as more familiar. Familiarity of high-probability, low-probability, and null-probability triplets will be compared following training.

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

Krystel Huxlin

James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology

University of Rochester

研究点 (1)

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