NCT07659691

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 15, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

hemianopiablindnessmultisensory training

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Month 6

Study Arms (1)

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.

Behavioral: Multisensory Rehabilitation

Interventions

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.

Also known as: multisensory training paradigm
multisensory training

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Blindness, CorticalHemianopsiaBlindness

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Rowland, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Jenkins, BSNRN, CCRC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations