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Not yet recruiting NCT07659691

Multisensory Rehabilitation of Vision Loss After Cortical Damage

No phase Interventional Cortical Blindness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multisensory Rehabilitation.
Who it may be relevant to
Registry conditions: Cortical Blindness. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Multisensory Rehabilitation
    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

Primary outcome measures

  • Change in National Institutes of Health Stroke Scale (NIHSS) score [Time frame: Month 6]
  • Change in Activity Inventory scores [Time frame: Month 6]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT07659691 · IRB00151786

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗