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Neglect Treatment by Prism Adaptation in the Acute Phase (aPA-NEGLECT)

U

University of Geneva, Switzerland

Status

Enrolling

Conditions

Unilateral Spatial Neglect

Treatments

Behavioral: Neutral Prism + visuo-motor activities
Behavioral: Prism 10 + visuo-motor activities

Study type

Interventional

Funder types

Other

Identifiers

NCT06078111
aPA-NEGLECT

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 2 patient groups

Prism 10
Experimental group
Description:
participants perform rehabilitation activities while wearing 10° visual field deviation prismatic goggles
Treatment:
Behavioral: Prism 10 + visuo-motor activities
Neutral Prism
Active Comparator group
Description:
participants perform rehabilitation activities while wearing neutral (no deviation) visual field deviation prismatic goggles
Treatment:
Behavioral: Neutral Prism + visuo-motor activities

Trial contacts and locations

1

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Central trial contact

Jennifer Martin, PhD; Roberta Ronchi, PhD

Data sourced from clinicaltrials.gov

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