Brain-controlled prosthetic communication for paralyzed individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.