BridgeMD
New treatment option for Quadriplegia
Official title Sensory Motor Transformations in Human Cortex
ClinicalTrials.gov ID: NCT01964261
What this study is testing
- What it's testing
- This research study is being conducted to develop a brain controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device such as a computer cursor or robotic limb by using their thoughts along with sensory feedback.
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
- High cervical spinal lesion
- Age 22-65
- Able to provide informed consent
- Able to understand and comply with instructions in English
- Communicate via speech
You likely can't join if
- Presence of memory problems
- Intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression if untreated
- Poor visual acuity
- Pregnancy
- Active infection or unexplained fever
See the full eligibility criteria
- High cervical spinal lesion
- Age 22-65
- Able to provide informed consent
- Able to understand and comply with instructions in English
- Communicate via speech
- Surgical clearance
- Life expectancy greater than 12 months
- Travel up to 60 miles to study locations up to five days per week
- Caregiver monitor for surgical site complications and behavioral changes on a daily basis
- Psychosocial support system
- Presence of memory problems
- 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
- Diabetes
- Autonomic dysreflexia
- History of seizure
- Implanted hydrocephalus shunt
- Previous neurosurgical history affecting parietal lobe function
- Medical conditions contraindicating surgery and chronic implantation of a medical device
- Prior cranioplasty
- 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.
- Implanted deep brain stimulator (DBS), DBS leads, or cochlear implant.
The study team makes the final eligibility decision.
Where it's taking place
- Downey, California, United States
- Los Angeles, California, United States
- Pasadena, California, United States
- Aurora, Colorado, 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 Downey, California, United States; Los Angeles, California, United States; Pasadena, California, United States; Aurora, Colorado, 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.