Multisensory Rehabilitation of Vision Loss After Cortical Damage

ConditionCortical Blindness

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Multisensory Rehabilitation
Behavioral
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: multisensory trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in National Institutes of Health Stroke Scale (NIHSS) score

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).

Time frame

Month 6

Change in Activity Inventory scores

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.

Time frame

Month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: