Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

NCT02886663 | Terminated

• 1 other identifier: OGT_2015_16
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemianopsia

Outcome Measures

Primary Outcomes (1)

• change in the sensitivity of detection of a visual stimulus after rehabilitation

  change in the mean number of points where the sensitivity is lower than 15db in each contralesional hemifield, before and after rehabilitation

  change from baseline sensitivity at week 22

Study Arms (2)

immediate rehabilitation

EXPERIMENTAL

Other: stimulation of the blind visual field

delayed rehabilitation

OTHER

Other: stimulation of the blind visual field

Interventions

stimulation of the blind visual field OTHER

delayed rehabilitation; immediate rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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)
• Patients aged 18 years and older

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvie CHOKRON

  Fondation OPH A de Rothschild

  STUDY DIRECTOR

• Olivier GOUT, MD

  Fondation OPH A de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: December 13, 2016
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

FR (1)