Multisensory Rehabilitation for Hemianopia

Overseen By Benjamin A Rowland, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Age over 85, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with hemianopia (partial vision loss in half of the visual field) improve their vision. The treatment, called the Multisensory Rehabilitation Paradigm, involves a special training program that uses both sight and sound to retrain the brain. Participants attend weekly sessions with coordinated visual and auditory stimulation. The trial seeks individuals with stable hemianopia for more than six months, no hearing or cognitive issues, and a willingness to join a three-month program.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially enhance vision through innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this multisensory rehabilitation paradigm is safe for hemianopia?

Research has shown that multisensory rehabilitation is safe for people with hemianopia, a condition where half of the field of vision is lost. Past studies reported no safety issues with this therapy. This treatment combines sight and sound to help improve vision and has been found to quickly and effectively restore visual function. Participants have handled the therapy well, making it a promising option for those seeking to regain vision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multisensory rehabilitation paradigm for hemianopia because it leverages a novel method of combining visual and auditory stimuli to potentially enhance vision recovery. Unlike traditional treatments that often focus solely on visual exercises or compensatory strategies, this approach integrates high-density, spatiotemporally congruent sensory inputs, which may promote more holistic and effective neural adaptation. By engaging multiple senses simultaneously, this method could offer a more dynamic and interactive way to retrain the brain, providing hope for improved functional recovery in those with unilateral blindness.

What evidence suggests that this multisensory rehabilitation paradigm is effective for hemianopia?

Research has shown that multisensory therapy, which combines sight and sound, can quickly and effectively improve vision in people with hemianopia. Hemianopia occurs when a person loses vision on one side. In this trial, unilaterally blind participants will undergo visual-auditory stimulation as part of the multisensory rehabilitation paradigm. Studies indicate that this therapy helps people regain sight in their blind area. Engaging the brain with both visual and auditory stimulation appears to enhance recovery. Overall, evidence suggests that this therapy offers a promising way to restore vision in those affected by hemianopia. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin A Rowland, PhD

Principal Investigator

Wake Forest Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults under 85 years old with a stable condition called hemianopia, where half of the visual field is lost. Participants should not have attention deficits related to vision (hemineglect) and must be able to see well enough in their unaffected field to do certain visual tasks.

Inclusion Criteria

I am willing to join the three-month program.

I am under 85 years old.

I can see clearly with my unaffected eye.

Exclusion Criteria

I am over 85 years old.

I cannot see differences in shapes or colors correctly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in weekly multisensory training sessions with visual-auditory stimulation

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multisensory Rehabilitation Paradigm

Trial Overview The study tests a new way to help people with hemianopia, which involves using multiple senses in therapy. The goal is to show that this approach can improve vision problems caused by damage to the primary visual cortex while leaving other brain areas intact.

How Is the Trial Designed?

Group I: Unilaterally blind Subjects will be exposed to visual-auditory stimulation Experimental Treatment 1 Intervention

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.

Multisensory Rehabilitation Paradigm is already approved in United States for the following indications:

Approved in United States as Multisensory Rehabilitation Paradigm for:

• Hemianopia

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Neuroscience Clinical Trial and Innovation Center (NCTIC)

Collaborator

Trials

1

Recruited

6+

Published Research Related to This Trial

Multisensory stimulation methods, such as motor imagery and music therapy, are currently used in stroke rehabilitation and can enhance the brain's ability to process and integrate sensory information, which is crucial for recovery.

Future stroke rehabilitation studies should focus on patient characteristics like age and gender, and utilize advanced neuroimaging techniques to better tailor interventions and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisensory stimulation in stroke rehabilitation. Johansson, BB.[2021]

Visual-auditory stimulation therapy has shown promising results in restoring visual sensitivity in two male patients with hemianopia, a condition typically considered permanent after stroke, with significant improvements observed within a few weeks.

Both patients were able to detect, describe, and localize visual stimuli in their previously blind field, demonstrating that this multisensory approach can effectively enhance visual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ameliorating Hemianopia with Multisensory Training. Rowland, BA., Bushnell, CD., Duncan, PW., et al.[2023]

A novel approach using passive auditory stimulation significantly improved visual detection in patients with hemianopia, showing nearly a 100% increase in performance shortly after stimulation on the blind side.

The improvement in visual detection was temporary, lasting about 1.5 hours, suggesting that auditory stimulation may activate residual visual pathways, highlighting a potential new method for rehabilitation of visual field disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive auditory stimulation improves vision in hemianopia. Lewald, J., Tegenthoff, M., Peters, S., et al.[2021]

A novel rehabilitation tool for patients with homonymous hemianopia showed significant improvements in visual search efficiency after 20 training sessions, with patients achieving shorter response times and faster performance in daily living tasks.

While there was no significant enlargement of the visual field, patients experienced a small increase in visual search fields, indicating that training can enhance overall visual function through compensatory eye movement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saccadic visual search training: a treatment for patients with homonymous hemianopia. Pambakian, AL., Mannan, SK., Hodgson, TL., et al.[2022]

A cohort study involving 19 patients (7 with neglect and 12 with neglect and hemianopia) showed that 10 sessions of multisensory audio-visual stimulation significantly improved clinical signs of neglect, with these improvements lasting for months after training.

The study suggests that the benefits of this training may be linked to activity in subcortical structures like the superior colliculus, which play a role in integrating sensory information and spatial orientation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and functional changes in neglect after multisensory stimulation. Làdavas, E., Tosatto, L., Bertini, C.[2022]

Auditory-visual training can effectively rehabilitate hemianopia in cats by restoring visual responsiveness in midbrain neurons, but only when the training stimuli are spatially and temporally congruent.

When the training stimuli were not aligned in space and time, rehabilitation failed, highlighting the importance of multisensory integration for effective recovery and suggesting similar strategies could be applied to human patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Principles of Multisensory Integration to Reverse Hemianopia. Dakos, AS., Jiang, H., Stein, BE., et al.[2021]

A new rehabilitation approach using audio-visual stimulation showed promising results in improving visual field defects in 8 patients, with training sessions lasting 4 hours daily over nearly 2 weeks.

Patients demonstrated significant improvements in visual detection and oculomotor exploration, which translated to better performance in daily activities, with benefits lasting up to one month after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual search improvement in hemianopic patients after audio-visual stimulation. Bolognini, N., Rasi, F., Coccia, M., et al.[2019]

This study will assess the effects of multisensory virtual reality (VR) training on various aspects of recovery in 224 acute stroke patients over a 6-year period, focusing on gait speed and limb function.

The trial aims to provide clearer evidence on the efficacy of VR training compared to conventional therapy, addressing previous limitations in sample size and long-term evaluation of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical study of rehabilitation interventions with multisensory interactive training in patients with cerebral infarction: study protocol for a randomised controlled trial. Lo, WL., Mao, YR., Li, L., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9908311/

Ameliorating Hemianopia with Multisensory Training - PMC These results indicate that the multisensory therapy is a rapid and effective method for restoring visual function in hemianopia.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04963075

NCT04963075 | Multisensory Rehabilitation of Hemianopia The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally ...

3. jneurosci.org jneurosci.org/content/43/6/1018.abstract

Ameliorating Hemianopia with Multisensory Training These results indicate that the multisensory therapy is a rapid and effective method for restoring visual function in hemianopia.

4. withpower.com withpower.com/trial/phase-hemianopsia-8-2021-59379

Multisensory Rehabilitation for Hemianopia Research shows that visual-auditory stimulation therapy can help people with hemianopia (blindness on one side) regain their ability to see in their blind field ...

5. frontiersin.org frontiersin.org/journals/behavioral-neuroscience/articles/10.3389/fnbeh.2015.00192/full

visual scanning, multisensory stimulation and vision ... VST and AViST aim at compensating vision loss by training eye scanning movements, whereas VRT aims at improving lost vision by activating residual visual ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05894434

Ameliorating Stroke-induced Hemianopia Via Multisensory ... This study seeks to determine the extent of the visual capabilities that can be restored in hemianopic stroke patients by a multisensory training technique ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36604169/

Ameliorating Hemianopia with Multisensory Training These results indicate that the multisensory therapy is a rapid and effective method for restoring visual function in hemianopia.SIGNIFICANCE ...