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Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

NCT ID: NCT02886663

Last Updated: 2019-12-13

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

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-13

Study Completion Date

2019-11-25

Brief Summary

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This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the cerebral localization and in 60% of stroke interesting the territory of the posterior cerebral artery.

Detailed Description

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Conditions

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Hemianopsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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immediate rehabilitation

Group Type EXPERIMENTAL

stimulation of the blind visual field

Intervention Type OTHER

delayed rehabilitation

Group Type OTHER

stimulation of the blind visual field

Intervention Type OTHER

Interventions

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stimulation of the blind visual field

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Presence of an homonymous visual field amputation after vascular retrochiasmatic lesion of the occipital region (visual cortex alone or with optical radiations or with other associated occipital areas)
* inclusion 3 months to 36 months after stroke
* Patients aged 18 years and older

Exclusion Criteria

* Brain injury history
* Severe neuropsychological, psychiatric or behavioral disorder
* Severe eye disorder or visual impairment (visual acuity less than 3/10)
* Progressive eye disorder (cataracts or glaucoma)
* insufficient French language proficiency to understand the questionnaires and rehabilitation tasks
* patient under legal protection
* patient's opposition to participate in the study
* no medical insurance coverage
* pregnant pr breastfeeding patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvie CHOKRON

Role: STUDY_DIRECTOR

Fondation OPH A de Rothschild

Olivier GOUT, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation OPH A de Rothschild

Locations

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Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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OGT_2015_16

Identifier Type: -

Identifier Source: org_study_id