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Rehabilitation of Visual Function After Brain Injury (IBOS-NVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03160131
Recruitment Status : Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
The Institute for the Blind and Partially Sighted (IBOS)
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Rune Skovgaard Rasmussen, Copenhagen University Hospital at Herlev

Brief Summary:

In Denmark, about 120,000 people suffer from brain damage, of whom approx. 75,000 with brain damage after stroke. Serious and often lasting vision impairments affect 20% to 35% of people after stroke. Vision is the most important sense in humans, and even smaller permanent injuries can drastically reduce quality of life.

Vision impairments after brain damage inhibits rehabilitation and enhances other invalidating effects. Reduced vision results in impaired balance, increased risk of serious falls, increased support needs, reduced quality of life, and impaired ability to perform activities of daily living. Restoration of visual field impairments occur only to a small extent during the first month after brain damage, and therefore the time window for spontaneous improvements is very limited. Hence, brain-impaired persons with visual impairment will most likely experience chronically impaired vision already 4 weeks after brain injury and the need for visual compensatory rehabilitation is substantial.

Neuro Vision Technology (NVT) is an supervised training course where people with visual impairments are trained in compensatory techniques using special equipment. Through the NVT process, the individual's vision problems are carefully investigated and personal data is used to organize individual training sessions that practice the individual in coping with situations that cause problems in everyday life.

The purpose of this study is to investigate whether rehabilitation with NVT can cause significant and lasting improvement in functional capacity in persons with chronic visual impairments after brain injury. Improving eyesight is expected to increase both physical and mental functioning, thus improving the quality of life. Participants included in the project will be investigated in terms of both visual and mental functions, including quality of life, cognition and depression. Such an investigation has not been performed previously and can have a significant impact on vision rehabilitation both nationally and internationally.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Brain Injuries Stroke Hemorrhagic Traumatic Brain Injury Device: Neuro Vision Technology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation of Visual Function After Brain Injury - Effect of Neuro Vision Technology (NVT)
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention
All participants receive NVT course training and are tested at baseline and at the end of the study for primary and secondary endpoints.
Device: Neuro Vision Technology

The Neuro Vision Technology method uses a special device in the form of light panels and neurological vision tests that give an overview of cognitive difficulties. This light panel is connected to a computer.

Static scanning is investigated using the special light panel with 24 light bulbs divided into two rows, the panel length corresponding to the 180 degrees that normal and well-functioning human eyes can see. Where it is considered relevant, the study participants are referred to the ophthalmologist, specialist optician, or a reading / visual clinic to ensure participants the optimal starting point for using his or her vision.

Primary Outcome Measures :
  1. Ability to complete a mobility route [ Time Frame: 3 months ]
    Target identification and thus to compare how many targets are seen after the intervention.

Secondary Outcome Measures :
  1. Time to complete a mobility route [ Time Frame: 3 months ]
    Time consumption and thus speed to complete the mobility route. Through the route there are a number of targets (stars) that study participants should try to locate. Investigators measure the time spent by study participants on the route, as well as the number of targets ignored by any participant. Measured in minutes and seconds.

  2. National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) [ Time Frame: 3 months ]
    Questionnaire dealing with vision problems and concerns associated with a person's visual function. Measured in points summing up several scales.

  3. Short Form (36) Health Survey (SF-36) [ Time Frame: 3 months ]
    Assessment of quality of life. Measured in points summing up several scales.

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: 3 months ]
    Cognitive screening test that provides an estimate of the intellectual functional level.

  5. Fatigue Severity Scale-7 [ Time Frame: 3 months ]
    Short fatigue test.

  6. Multidimensional Fatigue Inventory 20 (MFI-20) [ Time Frame: 3 months ]
    Fatigue test used to assess the occurrence of physical fatigue, mental fatigue, activity level, motivation and general fatigue.

  7. Test of Attentional Performance (TAP) Test 2.3: Visual Field [ Time Frame: 3 months ]
    Test for field defects in which the subject will respond quickly to stimuli in the field of view.

  8. Behavioral Inattention Test (BIT) [ Time Frame: 3 months ]
    Test of attention and vision.

  9. Rey-Osterrieth's complex figure test [ Time Frame: 3 months ]
    Copying advanced visual figure (without recall).

  10. Modified Barthel-100 Index [ Time Frame: 3 months ]
    Assessment of invalidity rate and ability to perform activities of daily living.

  11. Hemisphere differences [ Time Frame: 3 months ]
    As part of the study, it will be assessed whether persons with lesion of right hemisphere, ie left-field hemianopia may be more likely to be disorientated and due to neglect will overlook more details - this is done by comparing trial participants with right vs. left hemispheric lesions.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 14 years or older with brain injury.
  • Persons who experience significant vision impairment.
  • Eye sight 6/18 or better.
  • The time from symptoms onset to study inclusion is between 6 weeks and 9 months.

Exclusion criteria:

  • Cognitive dysfunction.
  • Persons with anosognosia or severe neglect.
  • Inability to move independently at least 35 meters with or without assistance, including wheelchairs.
  • Inability to understand Danish or with communication disorders that prevent participation in tests.
  • Terminal disorder, other progressive disorder.
  • Significant abuse of alcohol or euphoric or narcotic drugs.
  • Serious disorders such as mental illness, especially severe depression.
  • New brain injury or other significant disorders emerging after study inclusion.
  • Impaired vision not due to brain damage, where the disorder is not considered to be permanent or where the field of vision does not cause significant disability.

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 identifier (NCT number): NCT03160131

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Contact: Anne Marie H Schaarup, OT +45 39452580
Contact: Rune S Rasmussen, MA, Ph.D. +45 28757500

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The Institute for the Blind and Partially Sighted (IBOS)
Copenhagen, Hellerup, Denmark, 2900
Contact: Anne Marie H Schaarup, OT    +45 39452580   
Principal Investigator: Anne Marie H Schaarup, OT         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
The Institute for the Blind and Partially Sighted (IBOS)
Copenhagen University Hospital at Herlev
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Study Chair: Karsten Overgaard, MD Copenhagen University Hospital at Herlev

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rune Skovgaard Rasmussen, MA, Ph.D., associate professor, Copenhagen University Hospital at Herlev Identifier: NCT03160131    
Other Study ID Numbers: H-17001534
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rune Skovgaard Rasmussen, Copenhagen University Hospital at Herlev:
Visual impairment
Neuro Vision Technology
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System