HemianopiaNCT04963075
Multisensory Rehabilitation of Hemianopia
A study testing multisensory rehabilitation paradigm in people with Hemianopia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemianopia
- What is being tested?
- multisensory rehabilitation paradigm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adults (<85) of either sex
- diagnosis of a stable homonymous hemianopia (>6 months) with absence of hemineglect
- lesion encompassing at least primary visual cortex but sparing parietal cortex
- normal auditory and cognitive function
- willingness to participate in the three month program
- ability to perform the visual discriminations in their intact field
Who cannot join
- adults (>85)
- normal auditory and cognitive function
- unwilling to participate in the three month program
- inability to perform the visual discriminations in their intact field
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Non-Invasive Multisensory Rehabilitation of Hemianopia
The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.
Read the detailed description
The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.
- Conditions
- Hemianopia
- Being tested
- multisensory rehabilitation paradigm
- Keywords
- visual cortex injury, stroke, blindness, cortical damage
- Medical subject headings
- Hemianopsia, Stroke, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multisensory rehabilitation paradigmDevice
In initial ("training") sessions, 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. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed.
| Study group | Role | What they receive |
|---|---|---|
| Unilaterally blind Subjects will be exposed to visual-auditory stimulation | Experimental | The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery. Receives: Device: multisensory rehabilitation paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Points Detected at Multiple Locations
To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better") - Visual fields are divided into "affected" areas of the field (detection < 50% on initial testing) and "intact" areas of the field (detection > 50% on initial testing), aggregate data are reported for each at the start and end of study
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start22 Sep 2021
- Primary completion18 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemianopiaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroscience Clinical Trial and Innovation Center (NCTIC)
- Responsible party
- Sponsor
- Investigators
- Benjamin Rowland, PhD, Principal investigator, Wake Forest Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963075
- Sponsor's protocol ID
- IRB00074687
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2021
- Last updated
- 30 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual Participant Data that underlie the results reported in this article, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Multisensory Rehabilitation of Hemianopia
- ClinicalTrials.gov ID
- NCT04963075
- Acronym / sponsor ID
- IRB00074687
- Conditions
- Hemianopia
- Keywords
- visual cortex injury, stroke, blindness, cortical damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Neuroscience Clinical Trial and Innovation Center (NCTIC)
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Posted 30 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.
Detailed description
The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery
| Arm | Type | Receives |
|---|---|---|
| Unilaterally blind Subjects will be exposed to visual-auditory stimulation | Experimental | Device: multisensory rehabilitation paradigmThe over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults (<85) of either sex
- diagnosis of a stable homonymous hemianopia (>6 months) with absence of hemineglect
- lesion encompassing at least primary visual cortex but sparing parietal cortex
- normal auditory and cognitive function
- willingness to participate in the three month program
Key exclusion criteria (4 listed)
- adults (>85)
- normal auditory and cognitive function
- unwilling to participate in the three month program
- inability to perform the visual discriminations in their intact field
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 rehabilitation paradigmIn initial ("training") sessions, 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. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed. | Device | Unilaterally blind Subjects will be exposed to visual-auditory stimulation |
Primary outcome
Number of Points Detected at Multiple Locations
Time frame: Month 3
To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better") - Visual fields are divided into "affected" areas of the field (detection < 50% on initial testing) and "intact" areas of the field (detection > 50% on initial testing), aggregate data are reported for each at the start and end of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual Participant Data that underlie the results reported in this article, after deidentification
Related trials for Hemianopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
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. This study is not recruiting at the moment.
Benjamin Rowland, PhD principal investigator
Wake Forest 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 paradigm in people with Hemianopia, 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 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?
Yes. Results are posted in the registry (first posted 30 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Points Detected at Multiple Locations (time frame: Month 3). 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 Apr 2026.