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New treatment option for Quadriplegia
Official title Visuomotor Prosthetic for Paralysis
ClinicalTrials.gov ID: NCT01958086
What this study is testing
- What it's testing
- The investigators objective is to run human clinical trials in which brain activity recorded through a "brain-chip" implanted in the human brain can be used to provide novel communication capabilities to severely paralyzed individuals by allowing direct brain-control of a computer interface. A prospective, longitudinal, single-arm early feasibility study will be used to examine the safety and effectiveness of using a neural communication system to control a simple computer interface and a tablet computer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Pathology resulting in paralysis
- Age 22-65 years
- Able to provide informed consent
- Understand and comply with instructions, if necessary, with the aid of a translator
- Able to communicate via speech
You likely can't join if
- Intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression if untreated
- Poor visual acuity
- Pregnancy
- Active infection or unexplained fever
- Scalp lesions or skin breakdown
See the full eligibility criteria
- Pathology resulting in paralysis
- Age 22-65 years
- Able to provide informed consent
- Understand and comply with instructions, if necessary, with the aid of a translator
- Able to communicate via speech
- Surgical clearance
- Life expectancy greater than 12 months
- Live within 60 miles of study location and willing to travel up to 5 days per week
- A regular caregiver to monitor the surgical site
- Psychosocial support system
- Stable ventilator status
- Intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression if untreated
- Poor visual acuity
- Pregnancy
- Active infection or unexplained fever
- Scalp lesions or skin breakdown
- HIV or AIDS infection
- Active cancer or chemotherapy
- Medically uncontrolled diabetes
- Autonomic dysreflexia
- History of seizure
- Implanted hydrocephalus shunt
- History of supratentorial brain injury or neurosurgery
- Medical conditions contraindicating surgery and chronic implantation of a medical device
- Unable to undergo MRI or anticipated need for MRI during study
- Nursing an infant or unwilling to bottle-feed infant
- Chronic oral or intravenous use of steroids or immunosuppressive therapy
- Suicidal ideation
- Drug or alcohol dependence
- Planning to become pregnant, or unwilling to use adequate birth control
- Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord stimulator.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Pasadena, California, United States
- Pomona, California, United States
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, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Pasadena, California, United States; Pomona, California, United States. 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.