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Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

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ClinicalTrials.gov Identifier: NCT04043429
Recruitment Status : Completed
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bernhard A. Sabel, University of Magdeburg

Brief Summary:
Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.

Condition or disease Intervention/treatment Phase
Hemianopia Brain Injuries, Traumatic Behavioral: Vision Restoration Training (VRT) Behavioral: Vision Exploration Training (VET) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Arm Intervention/treatment
Experimental: Vision Restoration Training (VRT)
home-based rehabilitation program which applies intense light stimulation via a PC-monitor to areas of residual vision with a duration of 1 hour daily/six days a week, subjects are asked to respond via button press upon appearance of light stimuli without eye movements
Behavioral: Vision Restoration Training (VRT)
Active Comparator: Vision Exploration Training (VET)
home-based rehabilitation program to train eye movements upon visual stimuli presented via a PC-monitor with a duration of 1 hour daily/six days a week, subjects are asked to shift their gaze towards targets and respond via button press upon detection of targets
Behavioral: Vision Exploration Training (VET)



Primary Outcome Measures :
  1. High Resolution Perimetry - Detectection performance change before vs. after training (%) [ Time Frame: 3 months ]
  2. Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%) [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Visual field defects after brain damage
  • lesion age above 6 months
  • documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging

Exclusion Criteria:

  • hemispatial neglect
  • complete blindness
  • severe psychotic diseases
  • serious drug abuse
  • chronic degenerative diseases (dementia, multiple sclerosis)
  • severe motor impairments
  • noticeable low intelligence influencing proper comprehension of diagnostic and training instructions
  • considerable impaired vision (visual acuity below 0.1 generated by amblyopia, opacity of cornea or lens, maculopathy and other retinal diseases where vision impairment is expected in the next month (e.g. subretinal neovascularisation, retinitis pigmentosa, diabetic retinopathy)
  • inability to fixate due to central scotoma, pathological nystagmus or other forms of fixation disabilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043429


Locations
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Germany
Inst. f. Medical Psychology, Univ. of Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg

Publications of Results:
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Responsible Party: Bernhard A. Sabel, Professor, Head of Institute, University of Magdeburg
ClinicalTrials.gov Identifier: NCT04043429     History of Changes
Other Study ID Numbers: VRT100
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After publication
Access Criteria: Contacting the PI
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Hemianopsia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Blindness
Eye Diseases
Signs and Symptoms