- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07659691
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kimberly Hawley, RN
- Phone Number: 3367164031
- Email: Kimberly.Hawley@Advocatehealth.org
Study Contact Backup
- Name: Wendy Jenkins, BSNRN, CCRC
- Phone Number: 336.716.3842
- Email: Wendy.Jenkins@AdvocateHealth.org
Study Locations
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
Contact:
- Wendy Jenkins, BSNRN, CCRC
- Phone Number: 336-716-3842
- Email: Wendy.Jenkins@AdvocateHealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: multisensory training
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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Month 6
|
|
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.
|
Month 6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Benjamin Rowland, PhD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00151786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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