Neuromotor Prosthetic to Treat Stroke-Related Paresis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke, Complication
- Sponsor
- Thomas Jefferson University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change from Baseline Motricity Index score at 4 months
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of the research is to develop a new medical device prototype to restore functional movement of an arm made weak due to a chronic stroke
Detailed Description
Microelectrode arrays implanted into the brain will decode signals to drive motors on the powered brace worn on the arm so that the patient can "power steer" his or her own arm. The ultimate goal is to create a fully implantable medical device that will restore movement in all parts of the body affected by a stroke. Independent movement will have functional benefits (e.g., being able to lift a fork to eat) and health benefits (e.g., decreasing the frequency of skin infections and preventing the formation of painful joint contractures).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be 18 years or older.
- •Clinical diagnosis of stroke (hemorrhagic or ischemic, cortical or subcortical), confirmed by brain computer tomography or magnetic resonance imaging, that occurred six or more months prior to enrollment
- •Must have arm weakness due to stroke.
- •Participant is willing to comply with all follow-up evaluations at the specified times.
- •Participant is able to provide informed consent prior to enrollment in the study.
- •The participant is fluent in English.
- •\> 24 on the Mini Mental Status Examination
- •Medically stable.
- •Passive flexion of shoulder in weakened upper extremity with range of \> 30 degrees or more
- •Passive abduction of shoulder in weakened upper extremity with range of \> 20 degrees or more
Exclusion Criteria
- •No medical condition requiring active anti-coagulation with a medication such as heparin, warfarin or rivaroxaban (note that anti-platelet agents such as aspirin or clopidogrel are acceptable)
- •No active wound healing or skin breakdown issues.
- •No history of poorly controlled autonomic dysreflexia.
- •Visual impairment such that extended viewing of a computer monitor would be challenging even with ordinary corrective lenses
- •Chronic oral or intravenous steroids or immunosuppressive therapy
- •A score of 23 or lower on Folstein's Mini-Mental Status Examination
- •Orthopedic conditions of either arm that would affect performance on study
- •Untreated psychiatric disturbances that would affect motivation and trial participation
- •Medical contraindications for general anesthesia, craniotomy, or surgery.
- •Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
Outcomes
Primary Outcomes
Change from Baseline Motricity Index score at 4 months
Time Frame: 4 months
The Motricity Index measures strength in the arms and legs after stroke. The weighted score is based on the ordinal 6 point scale of Medical Research Council to measure maximal isometric muscle strength. From: Collin and Wade. Assessing motor impairment after stroke: A pilot reliability study. J. Neurol. Neurosurg. Psychiatry, 1990.
Change from Baseline ADL, Hand and Recovery Scales within Stroke Impact Scale, at 4 months
Time Frame: 4 months
The Stroke Impact Scales assess how having a stroke impacts a person's life. The scale has 8 subscales which ask questions regarding a person's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). ADL = activities of daily living. From: Duncan et al. The Stroke Impact Scale Version 2.0 : Evaluation of Reliability, Validity, and Sensitivity to Change. Stroke, 1999.
Change from Baseline Fugl-Meyer Motor Impairment Score at 4 months
Time Frame: 4 months
The Fugl-Meyer assessment (FMA) is a stroke specific index for estimating the performance of motor function. Total scores of FMA-Upper limb range from 0-66. From: Fugl-Meyer et al. The post-stroke hemiplegic patient: a method for evaluation of physical performance. Scand. J. Rehabil. Med., 1975.
Change from Baseline Action Research Arm Test (ARAT) score at 4 months
Time Frame: 4 months
The Action Research Arm Test (ARAT) measures specific changes in the arm function in people who sustained cerebral damage resulting in arm weakness. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch and gross movements. Each sub scale has items ordered according to ascending difficulty: 0- can not perform any part of the test, 1- performs the test partially, 2- completes the test, but takes abnormally long time, 3- performs the test normally. The sum of all subscales are added to compute the total score. The total score ranges between 0 to 57. The higher score is considered to be better outcome. From: Yozbatiran et al. A standardized approach to performing the action research arm test. Neurorehabil. Neural Repair, 2008.
Secondary Outcomes
- Change from Baseline Braden skin health score at 4 months(4 months)