Brain-controlled prosthetic communication for paralyzed individuals
Visuomotor Prosthetic for Paralysis
This study is testing a brain-chip that helps people with severe paralysis control a computer directly with their thoughts to see if it can improve their ability to communicate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | California Institute of Technology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT01958086 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the use of a brain-chip implanted in the brain to enable severely paralyzed individuals to control a computer interface directly with their brain activity. The study will utilize a prospective, longitudinal, single-arm early feasibility approach to assess the safety and effectiveness of a neural communication system. Participants will undergo initial training in simplified computer environments, with the ultimate goal of achieving autonomous control over a Google Android tablet. The research focuses on understanding how different brain areas encode movement intentions and how this knowledge can enhance prosthetic performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-65 with paralysis who can provide informed consent and have a stable psychosocial support system.
Not a fit: Patients with intellectual impairments, active infections, or severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve communication and independence for individuals with quadriplegia.
How similar studies have performed: Previous studies have shown promising results in using brain activity to control prosthetics, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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.
Where this trial is running
Los Angeles, California and 2 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- California Institute of Technology — Pasadena, California, United States (Recruiting)
- Casa Colina Centers for Rehabilitation — Pomona, California, United States (Recruiting)
Study contacts
- Principal investigator: Richard A Andersen, PhD — California Institute of Technology
- Study coordinator: Ausaf Bari, MD, PhD
- Email: ABari@mednet.ucla.edu
- Phone: 310-825-5111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.