Multisensory Rehabilitation of Hemianopia

Hemianopia Clinical Trial

Official title:

Non-Invasive Multisensory Rehabilitation of Hemianopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963075
• Other study ID #: IRB00074687
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: April 2025

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: Benjamin Rowland, PhD
• Phone: 336-716-7096
• Email: browland[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hemianopia
• Hemianopsia

Intervention

Device:
• multisensory rehabilitation paradigm
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.

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Neuroscience Clinical Trial and Innovation Center (NCTIC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of points detected	To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better")	3 months
Primary	Reaction time	To assess recovery of function - reaction time of visual detection (continuous variable, lower values are "better")	3 months
Primary	Distance between perceived and actual stimulus location	To assess recovery of function - localization accuracy/error (continuous variable, lower error is "better")	3 months
Primary	Low-vision visual functioning questionnaire (LV-VFQ-48)	information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. The difficulty of each item is rated using the ordered response categories (lower is "better"): (1) not difficult, (2) slightly/moderately difficult, (3) extremely difficult, and (4) impossible. Patients were also allowed to respond that they do not perform an activity for nonvisual reasons.	Baseline
Primary	Low-vision visual functioning questionnaire (LV-VFQ-48)	information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. The difficulty of each item is rated using the ordered response categories (lower is "better"): (1) not difficult, (2) slightly/moderately difficult, (3) extremely difficult, and (4) impossible. Patients were also allowed to respond that they do not perform an activity for nonvisual reasons.	Month 3
Primary	Humphrey visual field test	The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. The Humphrey visual field test can also be used to detect conditions within the optic nerve of the eye, and certain neurological conditions as well. A normal visual field measures about 90 degrees temporally, 50 degrees superiorly and nasally, and 60 degrees inferiorly. (higher scores are better)	Baseline
Primary	Humphrey visual field test	The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. The Humphrey visual field test can also be used to detect conditions within the optic nerve of the eye, and certain neurological conditions as well. A normal visual field measures about 90 degrees temporally, 50 degrees superiorly and nasally, and 60 degrees inferiorly. (higher scores are better)	Month 3