Sensory Motor Transformations in Human Cortex

Launched by RICHARD A. ANDERSEN, PHD · Oct 15, 2013

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of technology called a brain-machine interface, which aims to help people with quadriplegia control devices like computers or robotic arms using their thoughts. The study will implant special electrodes into the brain that can pick up signals related to movement plans. These signals will then be sent to a computer, allowing patients to move a cursor or a robotic limb by simply imagining the movement. Additionally, the study will stimulate areas of the brain to create a sensation of touch when the robotic arm interacts with objects, giving participants a sense of feeling.

To participate in this trial, individuals must be aged 22 to 65, have a high cervical spinal injury, and be able to communicate and follow instructions in English. Participants will need to travel to the study location several times a week for monitoring and support. It's important to note that this study involves a surgical procedure to implant the devices, which are still considered experimental and not yet approved by the FDA. Participants will receive care and support throughout the process, and a caregiver will need to be available to help monitor for any complications.

Gender

ALL

Eligibility 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.