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Clinical Trials/NCT06078111
NCT06078111
Recruiting
Not Applicable

Neglect Treatment by Prism Adaptation in the Acute Phase

University of Geneva, Switzerland1 site in 1 country32 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unilateral Spatial Neglect
Sponsor
University of Geneva, Switzerland
Enrollment
32
Locations
1
Primary Endpoint
Unilateral spatial neglect
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
February 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Geneva, Switzerland
Responsible Party
Principal Investigator
Principal Investigator

Roberta Ronchi

Principal Investigator

University of Geneva, Switzerland

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Unilateral spatial neglect

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

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

Study Sites (1)

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