Cortical BlindnessNCT07659691
Multisensory Rehabilitation of Vision Loss After Cortical Damage
A study testing Multisensory Rehabilitation in people with Cortical Blindness, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cortical Blindness
- What is being tested?
- Multisensory Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Wendy Jenkins, BSNRN, CCRC, 336-716-3842, Wendy.Jenkins@AdvocateHealth.org
About this study
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.
Read the 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.
- Conditions
- Cortical Blindness
- Being tested
- Multisensory Rehabilitation
- Keywords
- hemianopia, blindness, multisensory training
- Medical subject headings
- Blindness, Cortical, Hemianopsia, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory RehabilitationBehavioural
Also called multisensory training paradigm
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.
| Study group | Role | What they receive |
|---|---|---|
| multisensory training | Experimental | 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. Receives: Behavioral: Multisensory Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical BlindnessStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A group of 30 hemianopic or quadrantanopic participants - Subjects will participate in weekly research sessions (\~2 hours.) for the next three months. This purposely extends beyond the window of expected recovery.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Rowland, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659691
- Sponsor's protocol ID
- IRB00151786
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Rehabilitation of Vision Loss After Cortical Damage
- ClinicalTrials.gov ID
- NCT07659691
- Acronym / sponsor ID
- IRB00151786
- Conditions
- Cortical Blindness
- Keywords
- hemianopia, blindness, multisensory training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A group of 30 hemianopic or quadrantanopic participants - Subjects will participate in weekly research sessions (~2 hours.) for the next three months. This purposely extends beyond the window of expected recovery.
| Arm | Type | Receives |
|---|---|---|
| multisensory training | Experimental | Behavioral: Multisensory RehabilitationAt 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisensory RehabilitationAlso: multisensory training paradigm12 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. | Behavioural | multisensory training |
Primary outcome
Change in National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Month 6
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).
Change in Activity Inventory scores
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Rowland, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Rehabilitation in people with Cortical Blindness, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Hawley, RN (3367164031, Kimberly.Hawley@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in National Institutes of Health Stroke Scale (NIHSS) score (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.