Visuomotor Prosthetic for Paralysis

Not Applicable

Recruiting

• Conditions: Quadriplegia

• Registration Number: NCT01958086
• Lead Sponsor: Richard A. Andersen, PhD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Inclusion Criteria:<br><br> - Pathology resulting in paralysis<br><br> - Age 22-65 years<br><br> - Able to provide informed consent<br><br> - Understand and comply with instructions, if necessary, with the aid of a translator<br><br> - Able to communicate via speech<br><br> - Surgical clearance<br><br> - Life expectancy greater than 12 months<br><br> - Live within 60 miles of study location and willing to travel up to 5 days per week<br><br> - A regular caregiver to monitor the surgical site<br><br> - Psychosocial support system<br><br> - Stable ventilator status<br><br>Exclusion Criteria:<br><br> - Intellectual impairment<br><br> - Psychotic illness or chronic psychiatric disorder, including major depression if<br> untreated<br><br> - Poor visual acuity<br><br> - Pregnancy<br><br> - Active infection or unexplained fever<br><br> - Scalp lesions or skin breakdown<br><br> - HIV or AIDS infection<br><br> - Active cancer or chemotherapy<br><br> - Medically uncontrolled diabetes<br><br> - Autonomic dysreflexia<br><br> - History of seizure<br><br> - Implanted hydrocephalus shunt<br><br> - History of supratentorial brain injury or neurosurgery<br><br> - Medical conditions contraindicating surgery and chronic implantation of a medical<br> device<br><br> - Unable to undergo MRI or anticipated need for MRI during study<br><br> - Nursing an infant or unwilling to bottle-feed infant<br><br> - Chronic oral or intravenous use of steroids or immunosuppressive therapy<br><br> - Suicidal ideation<br><br> - Drug or alcohol dependence<br><br> - Planning to become pregnant, or unwilling to use adequate birth control<br><br> - Implanted Cardiac Defibrillator, Pacemaker, vagal nerve stimulator, or spinal cord<br> stimulator.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject control of a tablet computer;Absence of infection or irritation