HemianopsiaREVOIRNCT02886663
Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia
A study testing stimulation of the blind visual field in people with Hemianopsia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemianopsia
- What is being tested?
- stimulation of the blind visual field
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2016to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- patient's opposition to participate in the study
- no medical insurance coverage
- pregnant pr breastfeeding patient
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- stimulation of the blind visual field
- Medical subject headings
- Hemianopsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation of the blind visual fieldOther
| Study group | Role | What they receive |
|---|---|---|
| immediate rehabilitation | Experimental | Not described Receives: Other: stimulation of the blind visual field |
| delayed rehabilitation | Other | Not described Receives: Other: stimulation of the blind visual field |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline sensitivity at week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start13 Dec 2016
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Why it stopped: Major inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemianopsiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sylvie CHOKRON, Study director, Fondation OPH A de RothschildOlivier GOUT, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886663
- Sponsor's protocol ID
- OGT_2015_16
- Acronym
- REVOIR
- Status last verified
- Dec 2019
- First submitted
- 29 Aug 2016
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia
- ClinicalTrials.gov ID
- NCT02886663
- Acronym / sponsor ID
- REVOIR / OGT_2015_16
- Conditions
- Hemianopsia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Major inclusion difficulties
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate rehabilitation | Experimental | Other: stimulation of the blind visual field |
| delayed rehabilitation | Other | Other: stimulation of the blind visual field |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stimulation of the blind visual field | Other | delayed rehabilitation, immediate rehabilitation |
Primary outcome
change in the sensitivity of detection of a visual stimulus after rehabilitation
Time frame: change from baseline sensitivity at week 22
change in the mean number of points where the sensitivity is lower than 15db in each contralesional hemifield, before and after rehabilitation
Results and safety
The study was stopped early (reason given: Major inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Related trials for Hemianopsia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
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Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie CHOKRON study director
Fondation OPH A de Rothschild
Olivier GOUT, MD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stimulation of the blind visual field in people with Hemianopsia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Major inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the sensitivity of detection of a visual stimulus after rehabilitation (time frame: change from baseline sensitivity at week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.