Neglect Treatment by Prism Adaptation in the Acute Phase
ConditionUnilateral Spatial Neglect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Geneva, Switzerland
About this trial
This project aims at unveiling the beneficial effects of prism adaptation as early rehabilitation technique to treat unilateral spatial neglect in the acute phase after a brain damage. This syndrome, frequent and very invalidating for daily life activities after a brain damage, is a cognitive disorder of lack of attention towards a part of the space. Patients at a first event brain injury hospitalized into the Neurology and Neurosurgery Departments and affected by spatial neglect will undergo to a protocol of five consecutive rehabilitation treatments, being assigned to the experimental (prisms) or control groups (neutral prisms). The effectiveness of the treatment will be assessed with cognitive, functional and motor-related measures, as well as a follow up 3 months later. These results can have a strong impact on the long-term functional outcome of these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First neurological event, affecting the right hemisphere or the left hemisphere (stroke, brain tumour post-surgery);
Structural images of the brain lesion available (magnetic resonance or tomographic scans);
Good Normal (or corrected) visual acuity;
Presence of USN, as assessed by a standard neuropsychological evaluation.
Disqualifiers
Previous neurological disorder and/or current or previous psychiatric disease.
Presence or suspicion of previous general cognitive deficits documented from the clinical dossier and/or suspicious of possible cognitive deficits ;
Presence of difficulty in task's comprehension preventing its completion;
Impossibility to sustain a research session of at least 30 minutes (e.g., attentional lability).
Trial design
Design model
Parallel
Treatments tested in this trial
Prism 10 + visuo-motor activities
BehavioralVisuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with 10 degrees of visual field deviation
Neutral Prism + visuo-motor activities
BehavioralVisuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with no visual field deviation
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Prism 10Experimental treatment 1 intervention
Group B: Neutral PrismActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Unilateral spatial neglect
Scores in the neuropsychological tasks administered just before and after the rehabilitation protocol: BEN battery, with the number of lateralized omissions in target cancellation, drawing and reading; bisection bias for the line bisection test
Time frame
Day 0; Day 5; 12 weeks after the end of the protocol2
Functional measures
Scores in the functional test testing USN administered just before and after the rehabilitation protocol: CBS scale, evaluating the impact of neglect in 10 daily living activities (range 0-30)
Time frame
Day 0; Day 5; 12 weeks after the end of the protocol3
Disability measures
Scale for assessing disability after stroke just before and after the rehabilitation protocol: FIM (range 18-126)
Time frame
Day 0; Day 5; 12 weeks after the end of the protocol4
Balance
Balance tests after stroke just before and after the rehabilitation protocol: PASS (range 0-36)
Time frame
Day 0; Day 5; 12 weeks after the end of the protocolSecondary outcomes
1
Neuropsychological tests: Right vs. Left neglect
Comparison of the improvements in neuropsychological tests of patients with right vs. left unilateral spatial neglect on the following measures: \- BEN test: numbers of the lateralized omissions left-right in the target cancellation, drawing, reading; bisection bias in the bisection test The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (omissions rates, bisection biases) and the incidence (percentage of patients) still defective vs. non-defective at each of these measures
Time frame
Day 5; 12 weeks after the end of the protocol2
Functional Measures: Right vs. Left neglect
Comparison of the improvements in the functional activities of daily living of patients with right vs. left unilateral spatial neglect on the following measures: \- CBS scale. The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (total score of the functional scale) and the incidence (percentage of patients) still defective vs. non-defective at this measure
Time frame
Day 5; 12 weeks after the end of the protocol3
Disability Measures: Right vs. Left neglect
Comparison of the improvements of the disability scale of patients with right vs. left unilateral spatial neglect on the following measures: \- FIM The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (total score of the scale) and the incidence (percentage of patients) still defective vs. non-defective at this measure
Time frame
Day 5; 12 weeks after the end of the protocol4
Balance: Right vs. Left neglect
Comparison of the improvements of balance of patients with right vs. left unilateral spatial neglect on the following measures: \- PASS The difference between patients with right vs. left spatial neglect following brain damaged will be computed by a difference in the outcome scores (total score of the scale) and the incidence (percentage of patients) still defective vs. non-defective at this measure
Time frame
Day 5; 12 weeks after the end of the protocolSponsors and contacts
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Source ClinicalTrials.gov