Multisensory Rehabilitation of Vision Loss After Cortical Damage
2026年8月26日 更新者：Wake Forest University Health Sciences
Damage to visual cortex on one side of the brain frequently produces a profound and permanent blindness in contralesional space (hemianopia), a debilitating condition that causes enormous suffering for patients and their families.
研究概览
详细说明
The over-arching objective of the current proposal is to evaluate the functional recovery of vision in hemianopic (blindness in one hemifield) and quadrantanopic (blindness in one quadrant) patients engaged with a multisensory training paradigm.
This will pave the way for clinical trials in which this simple, non-invasive training paradigm can be developed for therapeutic use to treat blindness resulting from cortical damage.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kimberly Hawley, RN
- 电话号码：3367164031
- 邮箱：Kimberly.Hawley@Advocatehealth.org
研究联系人备份
- 姓名：Wendy Jenkins, BSNRN, CCRC
- 电话号码：336.716.3842
- 邮箱：Wendy.Jenkins@AdvocateHealth.org
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences
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接触：
- Wendy Jenkins, BSNRN, CCRC
- 电话号码：336-716-3842
- 邮箱：Wendy.Jenkins@AdvocateHealth.org
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients will be recruited from the local subject population hospitalized/seen by Ophthalmology, Neurosurgery, and Neurology at Atrium Health Wake Forest Baptist
- diagnosis of stable homonymous hemianopia (>4 weeks) with absence of hemineglect
- a lesion encompassing at least primary visual cortex but sparing parietal cortex, to include lesions caused by an ischemic or hemorrhagic stroke or post-surgical changes due to an oncologic or non-oncologic tumor
- normal or correctable auditory and cognitive function
- willingness to participate in the three-month program
- ability to perform visual discriminations in their intact field
- life expectancy ≥12 months
Exclusion Criteria:
- diagnosis of an unstable homonymous hemianopia and/or with hemineglect,
- Abnormal or uncorrectable auditory and cognitive function
- unwillingness to participate in the program
- inability to perform the visual testing in their intact field
- life expectancy < 12 months
- Any other condition that would compromise their ability to complete the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：multisensory training
At the completion of this initial intervention (12 research sessions + clinical visits at the time of the first and last session), participants will receive a second kinetic visual field test and a 30-2 visual field test to measure any changes according to the clinical standard. Two additional follow-up procedures are scheduled for participants identified as showing visual recovery after the initial intervention. Three months after completing the initial treatment, participants will have an additional research visit. If testing during this visit reveals that vision has degraded from the initial series, participants will be scheduled for 2-5 additional research visits (with testing and training) to reinstate recovery with re-intervention. |
12 research sessions + clinical visits at the time of the first and last session - In each session, there will be a "training phase" in which subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space.
There will also be a "testing" phase during which they are presented with visual stimuli in virtual reality (VR) to assess multiple aspects of visual function.
This "visual battery" consists of innocuous stimuli, e.g., flashes of light or moving bars, presented at intensities consistent with those experienced during daily life.
Subjects detect or discriminate the stimuli (e.g., judge whether a stimulus was flashed, or which stimulus is brighter) and report confidence in assessments.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in National Institutes of Health Stroke Scale (NIHSS) score
大体时间：Month 6
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The National Institutes of Health Stroke Scale (NIHSS) is a standardized, 15-item physical and mental examination used by healthcare providers to objectively quantify the severity of an acute stroke.
Scores range from 0 (no neurological deficit) to 42 (severe impairment).
|
Month 6
|
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Change in Activity Inventory scores
大体时间：Month 6
|
A questionnaire that asks how vision affects everyday activities.
It helps show which daily tasks are most important to the participant and how difficult those tasks may be because of vision problems.
Patients rate the importance of a goal and the difficulty of tasks, resulting in an individually tailored dataset.
This adaptive approach provides a comprehensive profile of how visual limitations affect everyday life.
|
Month 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Benjamin Rowland, PhD、Wake Forest University Health Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年6月15日
首先提交符合 QC 标准的
2026年6月15日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.