Visuomotor Prosthetic for Paralysis

Launched by RICHARD A. ANDERSEN, PHD · Oct 7, 2013

Keywords

ClinConnect Summary

This clinical trial is exploring a new way for people with severe paralysis, specifically those with quadriplegia, to communicate and interact with technology. Researchers are testing a device called a "brain-chip" that can pick up brain signals and allow users to control a computer or tablet just by thinking about it. The goal is to help participants use devices to make phone calls, manage finances, watch movies, play games, and even control smart home devices, which could significantly enhance their quality of life.

To be eligible for this trial, participants need to be between 22 and 65 years old, have a medical condition that causes paralysis, and be able to give informed consent. They should also be able to communicate verbally with help if needed and have a stable support system in place. Each participant will have the brain-chip implanted for a period of 53 weeks to over six years, during which they will undergo training to learn how to control the tablet. The trial is currently recruiting participants, and those interested should be prepared to travel to the study location regularly for check-ups and training sessions.

Gender

ALL

Eligibility 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.