Neglect Treatment by Prism Adaptation in the Acute Phase

NCT ID: NCT06078111

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Unilateral Spatial Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Prism 10

participants perform rehabilitation activities while wearing 10° visual field deviation prismatic goggles

Group Type EXPERIMENTAL

Prism 10 + visuo-motor activities

Intervention Type BEHAVIORAL

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

participants perform rehabilitation activities while wearing neutral (no deviation) visual field deviation prismatic goggles

Group Type ACTIVE_COMPARATOR

Neutral Prism + visuo-motor activities

Intervention Type BEHAVIORAL

Visuo-motor activities of exploration in the left and right space, adapting activities of daily living, while wearing prisms with no visual field deviation

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Geneva, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Roberta Ronchi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Roberta Ronchi, PhD

Role: CONTACT

+41 (0)22 3728314

Jennifer Martin, PhD

Role: CONTACT

Facility Contacts

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Roberta Ronchi, PhD

Role: primary

+41 (0)22 3728314

Other Identifiers

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aPA-NEGLECT

Identifier Type: -

Identifier Source: org_study_id

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