Developing a brain-controlled device for people with quadriplegia
A Feasibility Study of the Ability of the Neural Prosthetic System 2 to Provide Direct Closed Loop Cortical Control of Extracorporeal Devices Through the Use of Intracortical Microstimulation in Patients With Quadriplegia
NA · California Institute of Technology · NCT01964261
This study is testing a new brain-controlled device that helps people with quadriplegia use their thoughts to control things like computers or robotic arms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | California Institute of Technology (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Downey, California and 3 other locations) |
| Trial ID | NCT01964261 on ClinicalTrials.gov |
What this trial studies
This research aims to create a brain-machine interface that allows individuals with spinal cord injuries to control external devices like computer cursors or robotic limbs using their thoughts. The study involves implanting fine electrodes in specific brain areas responsible for planning movements and providing sensory feedback. By recording neural activity and stimulating the cortex, researchers hope to understand how sensory information is transformed into motor commands, ultimately enabling better control of prosthetic devices. The study focuses on participants with high cervical spinal lesions to explore the potential of these neural prosthetics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-65 with high cervical spinal lesions who can provide informed consent and comply with study requirements.
Not a fit: Patients with memory problems, severe psychiatric disorders, or other medical conditions that contraindicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly enhance the quality of life for patients with quadriplegia by restoring some degree of movement and control.
How similar studies have performed: Other studies have shown promise in developing brain-machine interfaces for similar conditions, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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.
Where this trial is running
Downey, California and 3 other locations
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (RECRUITING)
- University of Southern California — Los Angeles, California, United States (RECRUITING)
- Richard Andersen — Pasadena, California, United States (RECRUITING)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Richard A Andersen, PhD — California Institute of Technology
- Study coordinator: Charles Liu, MD, PhD
- Email: chasliu@cheme.caltech.edu
- Phone: 800-872-2273
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.
Conditions: Quadriplegia, Neural, Prosthetic, Brain machine interface, brain computer interface, brain control, paralysis, tetraplegia