Neglect Treatment by Prism Adaptation in the Acute Phase

Unilateral Spatial Neglect Clinical Trial

— aPA-NEGLECT  

Official title:

Neglect Treatment by Prism Adaptation in the Acute Phase

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06078111
• Other study ID #: aPA-NEGLECT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: February 2026

Study information

• Verified date: October 2023
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: February 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Unilateral Spatial Neglect

Intervention

Behavioral:
• Prism 10 + visuo-motor activities
Visuo-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
Visuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with no visual field deviation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0; Day 5; 12 weeks after the end of the protocol
Primary	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)	Day 0; Day 5; 12 weeks after the end of the protocol
Primary	Disability measures	Scale for assessing disability after stroke just before and after the rehabilitation protocol: FIM (range 18-126)	Day 0; Day 5; 12 weeks after the end of the protocol
Primary	Balance	Balance tests after stroke just before and after the rehabilitation protocol: PASS (range 0-36)	Day 0; Day 5; 12 weeks after the end of the protocol
Secondary	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	Day 5; 12 weeks after the end of the protocol
Secondary	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	Day 5; 12 weeks after the end of the protocol
Secondary	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	Day 5; 12 weeks after the end of the protocol
Secondary	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	Day 5; 12 weeks after the end of the protocol
Secondary	Functional Measures: Follow-up	Assessment of the functional benefit of the treatment procedure 3-months after the rehabilitation on the following measure: - CBS: difference in the total score The difference between patients with spatial neglect who have been submitted to the prism 10 or the neutral prisms protocol will be compared in the follow up. The difference of the scores at the end of the protocol vs. in the follow-up will be performed for each group, and a differential score (prism 10 end of the protocol - prism 10 follow-up vs. neutral prisms end of the protocol - neutral prisms follow-up) will be also analysed to check for the maintenance of the effect. The differences will be computed using the total outcome scores and the incidence (percentage of patients) still defective vs. non-defective at this measure	12 weeks after the end of the protocol
Secondary	Balance: Follow-up	Assessment of the functional benefit of the treatment procedure 3-months after the rehabilitation on the following measure: - PASS: difference in the total score The difference between patients with spatial neglect who have been submitted to the prism 10 or the neutral prisms protocol will be compared in the follow up. The difference of the scores at the end of the protocol vs. in the follow-up will be performed for each group, and a differential score (prism 10 end of the protocol - prism 10 follow-up vs. neutral prisms end of the protocol - neutral prisms follow-up) will be also analysed to check for the maintenance of the effect. The differences will be computed using the total outcome scores and the incidence (percentage of patients) still defective vs. non-defective at this measure	12 weeks after the end of the protocol