Visual Field Restoration in Patients With Post-stroke Hom... | NCT02886663

Studies
Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

NCT02886663

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Terminated

Last Update Posted

Dec 13, 2019Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Hemianopsia

Interventions

stimulation of the blind visual field

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Major inclusion difficulties

Expanded Access Info

Start Date

Dec 13, 2016Actual

Primary Completion Date

Nov 25, 2019Actual

Completion Date

Nov 25, 2019Actual

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Aug 29, 2016

First Posted Date

Sep 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2019

Last Update Posted Date

Dec 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
immediate rehabilitation	Experimental		Other: stimulation of the blind visual field
delayed rehabilitation	Other		Other: stimulation of the blind visual field

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stimulation of the blind visual field	Other		delayed rehabilitation immediate rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sylvie CHOKRON	Fondation OPH A de Rothschild	Study Director
Olivier GOUT, MD	Fondation OPH A de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique Adolphe de Rothschild		Paris		75019	France

Condition Browse Module

MeSH Terms

ID	Term
D006423	Hemianopsia

Ancestor Terms

ID	Term
D014786	Vision Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided