Neglect Treatment by Prism Adaptation in the Acute Phase

NCT06078111 | Recruiting

• 1 other identifier: aPA-NEGLECT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Spatial Neglect

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Neuropsychological tests: Right vs. Left neglect

  Day 5; 12 weeks after the end of the protocol

• Functional Measures: 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

Study Arms (2)

Prism 10

EXPERIMENTAL

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

Behavioral: Prism 10 + visuo-motor activities

Neutral Prism

ACTIVE COMPARATOR

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

Behavioral: Neutral Prism + visuo-motor activities

Interventions

Prism 10 + visuo-motor activities 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

Prism 10

Neutral Prism + visuo-motor activities 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

Neutral Prism

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

University Hospital of Geneva

Geneva, Canton of Geneva, 1200, Switzerland

RECRUITING

Central Study Contacts

Roberta Ronchi, PhD

CONTACT

+41 (0)22 3728314; roberta.ronchi@hcuge.ch

Jennifer Martin, PhD

CONTACT

jennifer.martin@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CH (1)