Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach (VISIOTRAIN)
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|ClinicalTrials.gov Identifier: NCT01730560|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : November 13, 2017
Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Apart from the substitutive method that uses prisms directly placed on glasses, two main rehabilitative methods have been explored previously: one restorative and one compensatory. The most effective methods seem to be based on compensatory training paradigms that target eye movements. They rely on voluntary mass-practice that induces changes in exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies using this method have shown changes in visual scanning patterns but with only a marginal profit in terms of functional benefit.
In the present study, the investigators developed a new approach to the compensatory visual field training based solely on a bottom-up mechanism. It does not require the patients' ability to voluntarily maintain attention oriented to the affected field, which may be difficult for brain-damaged patients. As previously reported in other pathological contexts (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing voluntary and conscious implication of the patient can produce improvements by a more automatic process.
The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by hemianopic patients to automatically improve targeted eye movements into their blind visual field; and 2) that this will lead to behavioural improvements on ecologically valid tests of visual search.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Visual Field Defects||Other: Treatment A Other: Treatment B||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach|
|Actual Study Start Date :||November 29, 2010|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
Experimental: Arm 1:Treatment A
Treatment A (active) followed by treatment B (neutral)
Other: Treatment A
The computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible.
The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly.
Each treatment phase has the same pattern:
Experimental: Arm 2: Treatment B
Treatment B (neutral) followed by treatment A (active)
Other: Treatment B
Placebo treatment using the same computer-based training task, but including only the ramp phase.
Each treatment phase has the same pattern:
- Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B). [ Time Frame: 1 week ]
- Errors and omissions at each evaluation session for the visual search task [ Time Frame: 1, 2 and 5 weeks ]Mean RT difference, errors and omissions at several visual tasks (rapid scanning task, exploratory visual tasks, reading task) at each evaluation session Parameters of visual field perimetry before and after treatment Oculo-motor parameters during the different tasks (i.e. amplitude and latencies for saccades and fixations)
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): NCT01730560
|Service de Médecine Physique et de Réadaptation,Hôpital Henry Gabrielle|
|Saint Genis Laval, France, 69235|
|Principal Investigator:||Sophie Jacquin-Courtois, MD, PhD||Service de Médecine Physique et de Réadaptation|