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Trial registered on ANZCTR


Registration number
ACTRN12618000014257p
Ethics application status
Submitted, not yet approved
Date submitted
1/11/2017
Date registered
10/01/2018
Date last updated
10/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The first safety study of a Bionic Vision Prosthesis in adults with complete and untreatable blindness
Scientific title
Safety evaluation of implantation of an Intracortical Visual Prosthesis for Artificial Vision via Electrical Microstimulation of the Visual Cortex: A Pilot Study in adults with Untreatable bilateral complete vision impairment
Secondary ID [1] 293242 0
MVG:FIH:P1.0
Universal Trial Number (UTN)
U1111-1204-4608
Trial acronym
Linked study record
ACTRN12612000476831

Health condition
Health condition(s) or problem(s) studied:
Untreatable bilateral complete vision impairment 305291 0
Condition category
Condition code
Eye 304596 304596 0 0
Diseases / disorders of the eye
Neurological 304597 304597 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is the First-In-Human trial of a visual prosthesis developed by Monash Vision Group. The device, which comprises an array of 43 microelectrode and wireless circuitry encapsulated in a hermetically sealed ceramic case, shall be implanted in the primary visual cortex of up to three blind participants based upon participant-specific MRI and CT-derived data. Up to four devices are to be implanted in each participant, in a procedure that will last approximately two hours. The implantation procedure is to be performed by an experienced neurosurgeon who is familiar with the approach to the occipital lobe, where the Primary Visual Cortex is located. Once implanted, the devices will be powered and controlled wirelessly to deliver small electrical currents to the Primary Visual Cortex, which is expected to evoke visual percepts in the participant's visual field, called ‘phosphenes’.
In addition to the implantation procedure, this trial involves a two year training program, during which the participants will learn to construct simple images from the phosphenes created by the device. These images will be controlled by the researchers by delivering pulse trains of variable amplitude, duration, frequency, pulse timing and duty cycle from the microelectrode arrays, within the safety limits of the device. Participants are required to attend one full day of training per week at Monash University (up to 8 hours, including breaks).
The program begins with very simple tasks, which involve the participants describing the location and brightness of each phosphene that can be evoked. Psychometric curves for every phosphene will be characterised, and the spatial location will be mapped on a log-polar plot. More complex tasks, such as construction of images from contiguous phosphenes, will be attempted as the participant learns to interpret the visual data that is delivered. These tasks will be conducted in one on one sessions where the participant is seated, and the devices are controlled via a custom-designed headset worn by the participant. The headset creates a magnetic field that controls the devices wirelessly, thereby eliminating the need for any wires into the body.
If participants successfully learn to recognise objects in these simple tasks, then they will be given a portable adaptation of the system to use in navigational tasks. These tasks are designed to emulate real life situations, such as independently navigating a space or locating an object in a room. The purpose of these tasks is to allow the researchers to develop the device for take home use. However, a take home system is not within the scope of this study, and participants cannot take the portable system home.
Throughout the study, all results will be recorded in a descriptive manner, based upon the participant’s descriptions of what they see. Phosphene evocation thresholds will be determined for various pulse train parameters to determine the optimal settings for each participant. In addition, the proficiency with which participants complete tasks shall be recorded to determine any improvement over time.
Intervention code [1] 299505 0
Treatment: Devices
Intervention code [2] 299888 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303842 0
The primary outcome of the study is the safe implantation of a intracortical visual prosthesis using patient-specific MRI and CT-derived information, and subsequent attachment of the device to the occipital lobe of the brain. Since this is a safety study, the efficacy of the device in evoking phosphenes is a secondary outcome. The primary measure of safety is a clinical evaluation of the surgical procedure and subsequent recovery of the participant. Post-operative CT imaging will be used to confirm the device location before the participant is discharged from hospital after the implantation procedure. A battery of neuropsychological assessments chosen specifically for this study will be conducted periodically. These assessments comprise the MMPI 2RF assessment, selected components of the Wechsler Adult Intelligence and Memory assessments, the Californian Verbal Learning test, Verbal Fluency Controlled Oral Word Association task, Hayling Sentence Completion test, Paced Auditory Serial Addition Test and a tactile learning task. The tactile learning task is non-validated assessment used by clinical neuropsychologists to monitor non-verbal learning and spatial ability.
In addition, participant’s recovery and general health will be monitored during regular appointments to the neurosurgery and general medicine outpatient clinics.
Possible adverse events include seizure, infection, small intracerebral haematomas and cerebral oedema, which are to be assessed as per standard care for craniotomy. Possible adverse events during the training program include minor discomfort, disorientation, pain during electrical stimulation, and will be constantly monitored by the study personnel during device operation.
Timepoint [1] 303842 0
Baseline (CT, general health assessments, psychological assessments, psychiatric assessments, neuropsychological assessments), evaluations at 3 weeks (neurosurgery outpatient clinic), 6 weeks (general health assessment, neuropsychological assessment), 3 months (neurosurgery outpatient clinic), 6 months (general health assessment, neuropsychological assessment), 1 year (general health assessment, neuropsychological assessment, neurosurgical outpatient clinic), and 2 years (general health assessment, neuropsychological assessment, neurosurgical outpatient clinic) post-implantation.
Secondary outcome [1] 340263 0
The reliability of artificial vision via electrical stimulation of the primary visual cortex will be evaluated during the participant training program, which has been designed specifically for this study. The evocation threshold for each phosphene that can be evoked in the participant’s visual field will be periodically characterised on a psychometric curve. The spatial location of phosphenes will be periodically evaluated to observe any weekly variation in phosphene location.
Timepoint [1] 340263 0
Weekly evaluation from 2 weeks until 2 years post-operatively
Secondary outcome [2] 341436 0
The utility of artificial vision via electrical stimulation of the primary visual cortex will be evaluated during the participant training program. Localisation tasks and acuity tasks designed specifically for this study will be employed to measure the resolution of artificial vision and the participant’s ability to use artificial vision for object localisation and recognition. In addition, navigational tasks specifically for this study will be used to investigate the utility of artificial vision in simulated real life situations.
Timepoint [2] 341436 0
Weekly evaluation from 2 weeks until 2 years post-operatively

Eligibility
Key inclusion criteria
Untreatable bilateral complete vision impairment in the entire visual field due to any of the following (non-comprehensive): Glaucoma, Age-related Macular Degeneration (AMD), Retinitis pigmentosa (RP), Acquired retinal disease where there is no ability to place a retinal implant, Severe vitreous disease which is uncorrectable and results in blindness, Optic nerve disease and degeneration (e.g. severe optic neuritis, Devic's disease), Hereditary Optic Neuropathies, Inherited forms of optic nerve degeneration (e.g. Leber's hereditary optic neuropathy), Severe trauma to both eyes and or optic nerves, Enucleation of the eyes due to bilateral retinoblastoma, Sellar (pituitary) and parasellar tumours with optic chiasm compression, Pituitary apoplexy, or Pituitary bed haemorrhage with postoperative blindness.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residual vision, History of traumatic occipital cortex injury, Poor mobility with high falls/fracture risk, Psychiatric, psychological or neuropsychological disorders, History of chronic disease, including insulin-dependent diabetes mellitus, renal, liver or respiratory disease, Epilepsy, moderate to severe hypertension, arrhythmia, valvular disease, ischaemic heart disease, coagulation disorders, HIV, hepatitis B and C, or receiving or have a requirement for any of the following medication: Anticoagulant therapy (e.g. warfarin), Immunotherapy (e.g. monoclonal antibodies, corticosteroids), or Hormone replacement therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Given that this pilot study has a maximum sample size of three participants, statistical analyses is not feasible. This is an exploratory study to determine the safety and feasibility of an investigative device, and to collect the psychophysical data to facilitate the development of the future artificial vision systems. Findings will be reported in a descriptive manner.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9325 0
The Alfred - Prahran
Recruitment postcode(s) [1] 17992 0
3004 - Prahran
Recruitment postcode(s) [2] 17993 0
3800 - Monash University

Funding & Sponsors
Funding source category [1] 297871 0
University
Name [1] 297871 0
Monash University
Country [1] 297871 0
Australia
Primary sponsor type
University
Name
Monash University
Address
14 Alliance Lane,
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 296916 0
Hospital
Name [1] 296916 0
The Alfred hospital
Address [1] 296916 0
55 Commercial Rd,
Melbourne VIC 3004
Country [1] 296916 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298921 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 298921 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 298921 0
Australia
Date submitted for ethics approval [1] 298921 0
02/11/2017
Approval date [1] 298921 0
Ethics approval number [1] 298921 0

Summary
Brief summary
This project constitutes the pilot study of a direct-to-brain Bionic Eye. In this study, up to 3 blind participants will have four small devices placed over the area of the brain responsible for vision. This area is called the visual cortex, which is located at the back of the brain. Each device contains an array of microelectrodes (which are like tiny wires as thin as strands of hair) and electronic circuitry that is capable of delivering small electrical pulses to the brain via the microelectrodes. The devices are powered and controlled wirelessly, so no wires need to be implanted. When the visual cortex is electrically stimulated, small points of light are seen by the participant, which can be assembled into basic images after adequate training. This study aims to teach blind participants to ‘see’ using these basic images, thereby demonstrating the safety and utility of the direct-to-brain Bionic Eye.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78654 0
Prof Jeffrey V Rosenfeld
Address 78654 0
New Horizon Building,
20 Research Way,
Monash University,
Clayton VIC 3800
Country 78654 0
Australia
Phone 78654 0
+61 3 99054202
Fax 78654 0
Email 78654 0
[email protected]
Contact person for public queries
Name 78655 0
Julian Szlawski
Address 78655 0
Building 72,
Faculty of Engineering,
14 Alliance Lane,
Monash University,
Clayton VIC 3800
Country 78655 0
Australia
Phone 78655 0
+61 3 9905 1950
Fax 78655 0
Email 78655 0
[email protected]
Contact person for scientific queries
Name 78656 0
Arthur Lowery
Address 78656 0
Building 35,
Faculty of Engineering,
14 Alliance Lane,
Monash University,
Clayton VIC 3800
Country 78656 0
Australia
Phone 78656 0
+61 3 9905 3475
Fax 78656 0
Email 78656 0
[email protected]

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Current supporting documents:


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