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New treatment option for Blindness
Official title Development of a Cortical Visual Neuroprosthesis for the Blind
ClinicalTrials.gov ID: NCT02983370
What this study is testing
- What it's testing
- The objective of this study is to evaluate the usefulness of a cortical visual prosthesis based on intracortical microelectrodes to provide a limited but useful sense of vision to profoundly blind. This pilot study will provide important information on safety and efficacy for the development of an useful cortical visual neuroprosthesis for the blind.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participant is capable and willing to provide informed consent for participation in the trial.
- Severe visual impairment with bilateral visual loss.
- Greater than 18 years of age.
- General health: excellent.
- Following a general physical and neurological examination, patient must have normal serum electrolytes, C-reactive protein, complete blood count and...
You likely can't join if
- Age \ 70.
- Period of appropriate visual functions \< 12 years /lifetime.
- For medical reasons: Individuals with a history of seizure disorders, coagulopathy, cardiac arrythmias or ischemia, pulmonary, hepatic or renal...
- Vulnerable subject groups (e.g., pregnant women, prisoners, etc.).
- Persons unable to give written informed consent prior to participation in the study.
- Not able to perform the study during the full time period (at least 3 months).
See the full eligibility criteria
- Participant is capable and willing to provide informed consent for participation in the trial.
- Severe visual impairment with bilateral visual loss.
- Greater than 18 years of age.
- General health: excellent.
- Following a general physical and neurological examination, patient must have normal serum electrolytes, C-reactive protein, complete blood count and PT and PTT.
- No history of stroke, seizure, coagulopathy, cardiac arrhythmias or ischemia, pulmonary, hepatic or renal disease, nor transmissible viruses such as hepatitis or HIV.
- Stable dose of current regular medication for at least four weeks prior to trial entry.
- Able to perform the study during the full time period of up to 6 months. Special consideration will be given to patients with (1) detailed medical histories, including documentation of the onset, mechanism and evolution...
- Age \ 70.
- Period of appropriate visual functions \< 12 years /lifetime.
- For medical reasons: Individuals with a history of seizure disorders, coagulopathy, cardiac arrythmias or ischemia, pulmonary, hepatic or renal disease, and any other neurological disorder. Patients who carry a...
- Vulnerable subject groups (e.g., pregnant women, prisoners, etc.).
- Persons unable to give written informed consent prior to participation in the study.
- Not able to perform the study during the full time period (at least 3 months).
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the...
The study team makes the final eligibility decision.
Where it's taking place
- Elche, Alicante, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elche, Alicante, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.