Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy

NCT04041089 | Completed

• 1 other identifier: 18-AOI-02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders. The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.

Conditions

Posterior Cortical Atrophy

Outcome Measures

Primary Outcomes (1)

• Effectiveness evaluation

  Effectiveness will be evaluated a score based on success rate (from 0 to 10), reaction time and eye-recording .

  At week 34

Study Arms (3)

Recognition of objects

EXPERIMENTAL

Patients will do the therapy in the following order: object location, object manipulation and object recognition

Behavioral: Recognition of objects

Location of objects

EXPERIMENTAL

Patients will do the therapy in the following order: object recognition, object location, and object manipulation

Behavioral: Location of objects

Manipulation of objects

EXPERIMENTAL

Patients will do the therapy in the following order: object manipulation, object recognition and object location

Behavioral: Manipulation of objects

Interventions

Recognition of objects BEHAVIORAL

* Name of shapes / colors / images / objects * Classification of shapes / colors / images / objects

Recognition of objects

Location of objects BEHAVIORAL

* Search for frequent/rarse targets among distractors sharing one or more characteristics with the target * Hit/catch a stationary/mobile target as quickly as possible

Location of objects

Manipulation of objects BEHAVIORAL

* Storage of shapes/objects * Use of everyday objects (pen, cutlery, etc.)

Manipulation of objects

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>50 years old
• Male or Female
• Patients with a diagnosis of PCA according to the criteria of Tang-Wai et al (2004)
• MMS\>15
• Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator), with oral consent of the patient in all cases
• Anti-Alzheimer's and psychotropic treatments stable for one month, if taken by the patient
• Affiliation to a social security system

You may not qualify if:

• Uncorrected visual disorders with non-degenerative etiology (AV\<0.5)
• Person under the protection of justice
• Pregnant women (a pregnancy test will be performed in premenopausal women)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice

Nice, Alpes-Maritime, 06100, France

Location

Study Officials

• MOUTON Aurélie, Ph

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: September 2, 2019
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)