Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System.

BACKGROUND AND OBJECTIVES: Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, nonrandomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI. METHODS: Adults aged 18-75 years with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease were enrolled through 7 clinical sites in the United States. Participants underwent surgical implantation of 1 or 2 microelectrode arrays in the motor cortex of the dominant cerebral hemisphere. The primary safety outcome was device-related serious adverse events (SAEs) requiring device explantation or resulting in death or permanently increased disability during the 1-year postimplant evaluation period. The secondary outcomes included the type and frequency of other adverse events and the feasibility of the BrainGate system for controlling a computer or other assistive technologies. RESULTS: From 2004 to 2021, 14 adults enrolled in the BrainGate trial had devices surgically implanted. The average duration of device implantation was 872 days, yielding 12,203 days of safety experience. There were 68 device-related adverse events, including 6 device-related SAEs. The most common device-related adverse event was skin irritation around the percutaneous pedestal. There were no safety events that required device explantation, no unanticipated adverse device events, no intracranial infections, and no participant deaths or adverse events resulting in permanently increased disability related to the investigational device. DISCUSSION: The BrainGate Neural Interface system has a safety record comparable with other chronically implanted medical devices. Given rapid recent advances in this technology and continued performance gains, these data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT00912041. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explantation, resulting in death, or resulting in permanently increased disability during the 1-year postimplant period.

Long-term Cardiovascular Manifestations and Complications of COVID-19: Spectrum and Approach to Diagnosis and Management.

Survivors of coronavirus disease 2019 (COVID-19) may experience persistent symptoms, abnormal diagnostic test findings, incident disease in specific organ systems, or progression of existing disease. Post-acute COVID-19 syndrome (PACS) is defined by persistent, recurrent, or new symptoms, findings, or diagnoses beyond four weeks after the initial infection. PACS has been characterized as a multi-organ syndrome, often with cardiopulmonary symptoms that include fatigue, dyspnea, chest pain, and palpitations. Cardiovascular pathologies in PACS include new-onset arrhythmia, myocarditis, unmasked coronary artery disease, and diastolic dysfunction as well as abnormal findings on electrocardiogram, troponin testing, and cardiac magnetic resonance imaging. In this review, we discuss the cardiovascular symptoms, pathophysiology, clinical investigation, and management strategies for cardiopulmonary symptoms of PACS. We offer a treatment algorithm for primary care clinicians encountering patients with cardiopulmonary PACS and discuss ongoing research on this topic.

Pediatric Rehabilitation Medicine (PRM): An Integrative Approach to Identifying and Treating Congenital and Childhood Disabilities.

[Full article available at http://rimed.org/rimedicaljournal-2017-11.asp].

Tendinopathy and Tendon Rupture Associated with Statins.

Use of statins may be associated with certain tendinopathies and tendon ruptures, especially of the Achilles, quadriceps, and distal biceps tendons. Tendinopathy usually occurs within the first year of statin use and improves after the drug therapy is stopped. Systemic conditions with a higher risk of tendon rupture include diabetes, gout, rheumatoid arthritis, and chronic kidney disease. Certain drugs, such as corticosteroids and fluoroquinolones, have also been implicated in tendon ruptures. Patients with these systemic conditions who are taking statins in combination with other drugs that increase the risk of tendon injury should be educated about this risk and alternative treatments, including diet and exercise.

Low back pain, radiculopathy, and bilateral proximal hamstring ruptures: a case report.

Low back pain (LBP) is a common complaint in the United States, with an incidence of 6.3%-15.4% and yearly recurrence in 54%-90% of patients.1 Trends show more frequent diagnostic testing, opioid use, and surgical intervention as the incidence of LBP increases.2 LBP is defined as pain at and near the lumbosacral region that can vary with physical activity and time. LBP is usually related to pathology of muscles, ligaments, spinal column joints, nerve roots, and the spinal cord. During the assessment of LBP, practitioners must also consider less common causes of pain in that region. For instance, patients with indolent or nighttime pain may have infectious or malignant processes. Referred pain from injuries to pelvic musculature or abdominal contents should be considered, especially following a traumatic event. One of these injuries, which can present as acute low back pain, is rupture of the proximal hamstring tendon. On rare occasion, concomitant LBP, radiculopathy, and hamstring injuries can occur;. This diagnostic challenge is described in the following case.

Neuronal ensemble control of prosthetic devices by a human with tetraplegia.

Neuromotor prostheses (NMPs) aim to replace or restore lost motor functions in paralysed humans by routeing movement-related signals from the brain, around damaged parts of the nervous system, to external effectors. To translate preclinical results from intact animals to a clinically useful NMP, movement signals must persist in cortex after spinal cord injury and be engaged by movement intent when sensory inputs and limb movement are long absent. Furthermore, NMPs would require that intention-driven neuronal activity be converted into a control signal that enables useful tasks. Here we show initial results for a tetraplegic human (MN) using a pilot NMP. Neuronal ensemble activity recorded through a 96-microelectrode array implanted in primary motor cortex demonstrated that intended hand motion modulates cortical spiking patterns three years after spinal cord injury. Decoders were created, providing a 'neural cursor' with which MN opened simulated e-mail and operated devices such as a television, even while conversing. Furthermore, MN used neural control to open and close a prosthetic hand, and perform rudimentary actions with a multi-jointed robotic arm. These early results suggest that NMPs based upon intracortical neuronal ensemble spiking activity could provide a valuable new neurotechnology to restore independence for humans with paralysis.

Olanzapine for the treatment of hemiballismus: A case report.

Hemiballismus is a rare movement disorder characterized by involuntary, large amplitude movements of the limbs of 1 side of the body. We describe the case of a man in his late sixties with slurred speech, agitation, and right-sided hemiballismus resulting from a left thalamic hemorrhagic stroke. Treatment with haloperidol was unsuccessful, but both the hemiballismus and agitation diminished significantly after initiation of olanzapine (Zyprexa). The improvement in the hemiballismus was quantified by recording the number of hemiballistic movements that occurred while the patient performed standardized 30-minute sessions (daily for 5d). With the first task (reaching within the base of support while seated), the average number of hemiballismic movements per session decreased from a baseline of 23.5 to 3.0 in the upper extremity and from 20.5 to 7.0 in the lower extremity. With the second task (catching a ball while seated), the abnormal movements decreased from 52 to 6.3 in the upper extremity and from 34.5 to 2.7 in the lower extremity. This case suggests that olanzapine may be a valuable pharmacologic alternative for patients with hemiballismus.

Tizanidine for the treatment of intention myoclonus: a case series.

OBJECTIVE: To evaluate the effectiveness of tizanidine in treating intention myoclonus. DESIGN: Case series. SETTING: Inpatient rehabilitation center. PARTICIPANTS: Three subjects whose activities of daily living were impaired due to intention myoclonus related to mitochondrial encephalomyopathy, stroke, and multiple sclerosis (MS). INTERVENTION: Tizanidine. MAIN OUTCOME MEASURES: Reduction in intention myoclonus and change in score on the FIM instrument. RESULTS: The patient with mitochondrial encephalomyopathy had left upper- and lower-extremity intention myoclonus; the patient with stroke had left upper intention myoclonus; and the patient with MS had right upper- and left lower-intention myoclonus. In the patient with mitochondrial encephalomyopathy, the FIM score increased from 90 to 103 points over 2 days of tizanidine. The stroke patient's FIM score improved only from 74 to 79 after 4 weeks of tizanidine. The patient with MS improved from 83 to 101 after 6 days of tizanidine. All 3 patients had almost full resolution of the intention myoclonus. All continued on tizanidine except the patient with stroke, who had minimal gains and a low systolic blood pressure. None of the patients experienced significant sedation or hypotension. CONCLUSIONS: Tizanidine may be a safe and effective option for treating intention myoclonus that occurs in a variety of neurologic conditions.

The effects of dehydration on rehabilitation outcomes of elderly orthopedic patients.

OBJECTIVE: To study the effects of dehydration, by using the indices of prerenal azotemia and orthostasis, on the rehabilitation outcomes of elderly orthopedic patients. DESIGN: Prospective, pilot study. SETTING: Regional inpatient rehabilitation center. PARTICIPANTS: A consecutive sample of 39 patients (29 women, 10 men), ranging in age from 58 to 94 years (mean, 78y), of whom 13 had total hip replacements, 12 had total knee replacements, and 14 had hip fractures. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Length of stay (LOS), change in the FIM trade mark instrument score, and discharge to home. RESULTS: The mean LOS was significantly longer in the group with prerenal azotemia (n=21, 12.9+/-3.0d, t=2.49, P<.01) than in the nonazotemic group (n=18, 9.4+/-4.6d). LOS was also significantly longer in the orthostatic group (n=18, 13.7+/-3.4d, t=2.94, P<.01) than in the nonorthostatic group (n=21, 9.8+/-3.9d). Two-way analysis of variance showed a statistically significant effect on LOS for both azotemia (F=8.4, P=.006) and orthostasis (F=10.5, P=.003). A statistical interaction existed (F=4.7, P=.038), but it was more pronounced in the absence of both conditions, as opposed to the presence of both. LOS for the group with both azotemia and orthostasis was 13.6+/-2.7 days (n=10, F=4.7, P=.038), in contrast to 7.2+/-2.8 days in the group without either condition (n=10). Of the patients who had neither azotemia nor orthostasis, 100% (n=10) went home; 80% (n=8) of patients who had both conditions went home. Logistic regression analysis, however, did not show a statistically significant correlation between discharge to home and the presence of azotemia, orthostasis, or both. CONCLUSION: Prerenal azotemia and orthostasis are present in a significant number of elderly orthopedic patients and have a major effect on rehabilitation outcomes.