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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02886663
Other study ID # OGT_2015_16
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 13, 2016
Est. completion date November 25, 2019

Study information

Verified date December 2019
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date November 25, 2019
Est. primary completion date November 25, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
stimulation of the blind visual field


Locations

Country Name City State
France Fondation Ophtalmologique Adolphe de Rothschild Paris

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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