Status:
COMPLETED
Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia
Lead Sponsor:
Richard A. Andersen, PhD
Collaborating Sponsors:
University of Southern California
Rancho Los Amigos National Rehabilitation Center
Conditions:
Tetraplegia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This research study is being done to develop a brain controlled medical device, called a brain-machine interface or BMI, that will provide people with a spinal cord injury some ability to control an e...
Eligibility Criteria
Inclusion
- High cervical spinal lesion
- Able to provide informed consent
- Able to understand and comply with instructions in English
- 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
Exclusion
- Presence of memory problems
- intellectual impairment
- Psychotic illness or chronic psychiatric disorder, including major depression
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01849822
Start Date
February 1 2013
End Date
January 1 2019
Last Update
April 30 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
2
University of Southern California
Los Angeles, California, United States, 90033
3
California Institute of Technology
Pasadena, California, United States, 91125