Neglect Treatment by Prism Adaptation in the Acute Phase

Not Applicable

Recruiting

• Conditions: Unilateral Spatial Neglect
• Interventions: Behavioral: Neutral Prism + visuo-motor activities; Behavioral: Prism 10 + visuo-motor activities

• Registration Number: NCT06078111
• Lead Sponsor: University of Geneva, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Study Start: 2023-11-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-09
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral Prism	Neutral Prism + visuo-motor activities	participants perform rehabilitation activities while wearing neutral (no deviation) visual field deviation prismatic goggles
Prism 10	Prism 10 + visuo-motor activities	participants perform rehabilitation activities while wearing 10° visual field deviation prismatic goggles

Primary Outcome Measures

Name	Time	Method
Unilateral spatial neglect	Day 0; Day 5; 12 weeks after the end of the protocol	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
Disability measures	Day 0; Day 5; 12 weeks after the end of the protocol	Scale for assessing disability after stroke just before and after the rehabilitation protocol: FIM (range 18-126)
Functional measures	Day 0; Day 5; 12 weeks after the end of the protocol	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)
Balance	Day 0; Day 5; 12 weeks after the end of the protocol	Balance tests after stroke just before and after the rehabilitation protocol: PASS (range 0-36)

Secondary Outcome Measures

Name	Time	Method
Functional Measures: Right vs. Left neglect	Day 5; 12 weeks after the end of the protocol	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
Neuropsychological tests: Right vs. Left neglect	Day 5; 12 weeks after the end of the protocol	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
Disability Measures: Right vs. Left neglect	Day 5; 12 weeks after the end of the protocol	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
Balance: Right vs. Left neglect	Day 5; 12 weeks after the end of the protocol	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
Functional Measures: Follow-up	12 weeks after the end of the protocol	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
Balance: Follow-up	12 weeks after the end of the protocol	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

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, Genf, Switzerland