ClinicalTrials.gov identifier: NCT01964261
Purpose: This research study is being conducted to develop a brain-controlled medical device, called a brain-machine interface. The device will provide people with a spinal cord injury some ability to control an external device, such as a computer cursor or robotic limb, by using their thoughts along with sensory feedback.
Study type: Interventional
Study design: Safety/efficacy study, single group assessment, open label
Estimated enrollment: 2
Eligibility criteria: Both genders eligible; ages 22 years to 65 years. Patients must have a cervical spinal lesion; be able to provide informed consent, understand and comply with instructions in English and communicate via speech; must have surgical clearance; must have life expectancy greater than 12 months; must be able to travel up to 60 miles to study locations up to 5 days per week; must have a caregiver monitor for surgical site complications and behavioral changes on a daily basis; and must have a psychosocial support system. Excludes patients who have memory problems; intellectual impairment; psychotic illness or chronic psychiatric disorder; 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; chronic oral and intravenous use of steroids or immunosuppressive therapy; suicidal ideation; drug or alcohol dependence; planning to become pregnant; implanted cardiac defibrillator, pacemaker, vagal nerve stimulator or spinal cord stimulator; and implanted deep brain stimulator (DBS), DBS leads or cochlear implant.
Study start date: November 2013
Estimated study completion date: January 2018
Estimated primary completion date: The final collection date for primary outcome measures will be October 2017.
Primary outcome measures: Primary control over end effector and absence of infection or irritation are measured 1 year after array implantation.
Secondary outcome measures: N/A
Sponsors and collaborators: Richard A. Andersen, PhD, University of Southern California and Rancho Los Amigos National Rehabilitation Center
Contact: Charles Liu, MD, PhD, 800-872-2273, chasliu@cheme.caltech.edu; Mindy Aisen, MD, 562-401-8111, maisen@dhs.lacounty.gov
Information acquired from: Richard A. Andersen, PhD, California Institute of Technology, via clinicaltrials.gov
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