BlindnessBrainPortNCT02643238
Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
A study testing BrainPort in people with Blindness, run by Akron Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of an artificial vision system called Brainport system in blind patients To investigate visual, and oculomotor (eye motion) mechanisms involved in the use of the Brainport system. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Blindness
- What is being tested?
- BrainPort
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2022
- 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 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Less than 25 years of age and be able to cooperate for full study protocol
- Have a clinical diagnosis of blindness (light perception or worse), or 20/20 vision corrected or otherwise.
- Have completed a complete ophthalmic evaluation.
- Patients recruited must be able to undergo the training to use the BrainPort® system.
- Sign informed consent (family) or assent (patient).
Who cannot join
- Have any neurologic disease, developmental delay, congenital genetic syndromes, congenital organ malformation, malformation syndromes or metabolic disease.
- Be on any medications known to affect the visual system
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the use of an artificial vision system called Brainport system in blind patients To investigate visual, and oculomotor (eye motion) mechanisms involved in the use of the Brainport system.
Read the detailed description
The prevalence of blindness in the US adult population is 0.8% and ranges from about 3/10000 to 15/10000 in children. Data from world health organization show that about 500,000 children become blind each year. The annual cost of blindness to the federal government is $4 billion and the cost of a lifetime of support and unpaid taxes for a blind person is about $1 million.
There is a need to restore vision for blind patients. Research on vision restoration develops fast. There are multiple types of approaches toward producing useful artificial vision. One of them directly sends images from a video camera to the visual cortex via an electrode array that is intracranially placed on the visual cortex of blind patients. Another one surgically places an electrode array beneath the retina for patients whose optic nerves are still healthy. Both of them require major surgery and have high risks, and neither is available for routine clinical application.
The one that is non-invasive and easy to use is called the BrainPort® system. The BrainPort® system is manufactured by Wicab, Inc. It is commercially available and affordable to any consumer. This system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. The electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field.
- Conditions
- Blindness
- Being tested
- BrainPort
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainPortDevice
This system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. The electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field
| Study group | Role | What they receive |
|---|---|---|
| Group A - Blind | Experimental | Subjects will be trained to ambulate through a 40-foot obstacle course by the occupational therapy colleagues at Akron Children's Hospital after which they will be scored on their performance while using the BrainPort® system. Receives: Device: BrainPort |
| Group C - Control | Active comparator | Subjects will be trained to ambulate through a 40-foot obstacle course by the occupational therapy colleagues at Akron Children's Hospital after which they will be scored on their performance while using the BrainPort® system. Receives: Device: BrainPort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Time to completion of obstacle path (over 25 trials) in seconds
To evaluate the usefulness of an artificial vision system called BrainPort® system in blind patients
Measured: 1 month
Secondary outcomes (1)
Average Number of errors during each trial (over 25 trials)
To investigate the visual mechanisms underlying how the visual sensory system is involved in information processing in the presence of tongue stimulation using sensory and visually evoked potentials
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startOct 2011
- Primary completionDec 2016
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for BlindnessStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Hertle, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643238
- Sponsor's protocol ID
- 111009
- Acronym
- BrainPort
- Status last verified
- Nov 2022
- First submitted
- 23 Dec 2015
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Normann RA, Maynard EM, Rousche PJ, Warren DJ. A neural interface for a cortical vision prosthesis. Vision Res. 1999 Jul;39(15):2577-87. doi: 10.1016/s0042-6989(99)00040-1.
PubMed 10396626Chowdhury V, Morley JW, Coroneo MT. Surface stimulation of the brain with a prototype array for a visual cortex prosthesis. J Clin Neurosci. 2004 Sep;11(7):750-5. doi: 10.1016/j.jocn.2003.12.010.
PubMed 15337140Chowdhury V, Morley JW, Coroneo MT. Stimulation of the retina with a multielectrode extraocular visual prosthesis. ANZ J Surg. 2005 Aug;75(8):697-704. doi: 10.1111/j.1445-2197.2005.03498.x.
PubMed 16076336World Health Organization. Preventing blindness in children: report of WHO/IAPB scientific meeting. Geneva: WHO, 2000. (WHO/PBL/00.77.)
Sachs HG, Schanze T, Wilms M, Rentzos A, Brunner U, Gekeler F, Hesse L. Subretinal implantation and testing of polyimide film electrodes in cats. Graefes Arch Clin Exp Ophthalmol. 2005 May;243(5):464-8. doi: 10.1007/s00417-004-1049-x. Epub 2004 Dec 1.
PubMed 15578200Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
PubMed 16385646Ptito M, Moesgaard SM, Gjedde A, Kupers R. Cross-modal plasticity revealed by electrotactile stimulation of the tongue in the congenitally blind. Brain. 2005 Mar;128(Pt 3):606-14. doi: 10.1093/brain/awh380. Epub 2005 Jan 5.
PubMed 15634727O'Shea, R. P., Roeber, U., & Bach, M. (2010). Evoked potentials: Vision. In E. B. Goldstein (Ed.), Encyclopedia of Perception (Vol. 1, pp. 399-400, xli). Los Angeles: Sage. ISBN 9781412940818
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation
- ClinicalTrials.gov ID
- NCT02643238
- Acronym / sponsor ID
- BrainPort / 111009
- Conditions
- Blindness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 31 Dec 2015 (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.
The purpose of this study is to evaluate the use of an artificial vision system called Brainport system in blind patients To investigate visual, and oculomotor (eye motion) mechanisms involved in the use of the Brainport system.
Detailed description
The prevalence of blindness in the US adult population is 0.8% and ranges from about 3/10000 to 15/10000 in children. Data from world health organization show that about 500,000 children become blind each year. The annual cost of blindness to the federal government is $4 billion and the cost of a lifetime of support and unpaid taxes for a blind person is about $1 million.
There is a need to restore vision for blind patients. Research on vision restoration develops fast. There are multiple types of approaches toward producing useful artificial vision. One of them directly sends images from a video camera to the visual cortex via an electrode array that is intracranially placed on the visual cortex of blind patients. Another one surgically places an electrode array beneath the retina for patients whose optic nerves are still healthy. Both of them require major surgery and have high risks, and neither is available for routine clinical application.
The one that is non-invasive and easy to use is called the BrainPort® system. The BrainPort® system is manufactured by Wicab, Inc. It is commercially available and affordable to any consumer. This system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. The electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Blind | Experimental | Device: BrainPortSubjects will be trained to ambulate through a 40-foot obstacle course by the occupational therapy colleagues at Akron Children's Hospital after which they will be scored on their performance while using the BrainPort® system. |
| Group C - Control | Active comparator | Device: BrainPortSubjects will be trained to ambulate through a 40-foot obstacle course by the occupational therapy colleagues at Akron Children's Hospital after which they will be scored on their performance while using the BrainPort® system. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Less than 25 years of age and be able to cooperate for full study protocol
- Have a clinical diagnosis of blindness (light perception or worse), or 20/20 vision corrected or otherwise.
- Have completed a complete ophthalmic evaluation.
- Patients recruited must be able to undergo the training to use the BrainPort® system.
- Sign informed consent (family) or assent (patient).
Key exclusion criteria (2 listed)
- Have any neurologic disease, developmental delay, congenital genetic syndromes, congenital organ malformation, malformation syndromes or metabolic disease.
- Be on any medications known to affect the visual system
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 |
|---|---|---|
| BrainPortThis system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. The electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field | Device | Group A - Blind, Group C - Control |
Primary outcome
Average Time to completion of obstacle path (over 25 trials) in seconds
Time frame: 1 month
To evaluate the usefulness of an artificial vision system called BrainPort® system in blind patients
1 secondary outcome
Average Number of errors during each trial (over 25 trials)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 10396626Normann RA, Maynard EM, Rousche PJ, Warren DJ. A neural interface for a cortical vision prosthesis. Vision Res. 1999 Jul;39(15):2577-87. doi: 10.1016/s0042-6989(99)00040-1.
- Background: PubMed 15337140Chowdhury V, Morley JW, Coroneo MT. Surface stimulation of the brain with a prototype array for a visual cortex prosthesis. J Clin Neurosci. 2004 Sep;11(7):750-5. doi: 10.1016/j.jocn.2003.12.010.
- Background: PubMed 16076336Chowdhury V, Morley JW, Coroneo MT. Stimulation of the retina with a multielectrode extraocular visual prosthesis. ANZ J Surg. 2005 Aug;75(8):697-704. doi: 10.1111/j.1445-2197.2005.03498.x.
- BackgroundWorld Health Organization. Preventing blindness in children: report of WHO/IAPB scientific meeting. Geneva: WHO, 2000. (WHO/PBL/00.77.)
- Background: PubMed 15578200Sachs HG, Schanze T, Wilms M, Rentzos A, Brunner U, Gekeler F, Hesse L. Subretinal implantation and testing of polyimide film electrodes in cats. Graefes Arch Clin Exp Ophthalmol. 2005 May;243(5):464-8. doi: 10.1007/s00417-004-1049-x. Epub 2004 Dec 1.
- Background: PubMed 16385646Danilov Y, Tyler M. Brainport: an alternative input to the brain. J Integr Neurosci. 2005 Dec;4(4):537-50. doi: 10.1142/s0219635205000914.
- Background: PubMed 15634727Ptito M, Moesgaard SM, Gjedde A, Kupers R. Cross-modal plasticity revealed by electrotactile stimulation of the tongue in the congenitally blind. Brain. 2005 Mar;128(Pt 3):606-14. doi: 10.1093/brain/awh380. Epub 2005 Jan 5.
- BackgroundO'Shea, R. P., Roeber, U., & Bach, M. (2010). Evoked potentials: Vision. In E. B. Goldstein (Ed.), Encyclopedia of Perception (Vol. 1, pp. 399-400, xli). Los Angeles: Sage. ISBN 9781412940818
- Individual participant dataSharing planned: No
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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.
Richard Hertle, MD principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BrainPort in people with Blindness, run by Akron Children's Hospital at 1 site in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 16 Nov 2022. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average Time to completion of obstacle path (over 25 trials) in seconds (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643238, which also lists 8 linked publications.
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 16 Nov 2022.