Long-term use of a neural prosthesis in progressive paralysis.
Ontology highlight
ABSTRACT:
SUBMITTER: Okahara Y
PROVIDER: S-EPMC6235856 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
Publications
Long-term use of a neural prosthesis in progressive paralysis.
Okahara Yoji Y Takano Kouji K Nagao Masahiro M Kondo Kiyohiko K Iwadate Yasuo Y Birbaumer Niels N Kansaku Kenji K
Scientific reports 20181114 1
Brain-computer interfaces (BCIs) enable communication with others and allow machines or computers to be controlled in the absence of motor activity. Clinical studies evaluating neural prostheses in amyotrophic lateral sclerosis (ALS) patients have been performed; however, to date, no study has reported that ALS patients who progressed from locked-in syndrome (LIS), which has very limited voluntary movement, to a completely locked-in state (CLIS), characterized by complete loss of voluntary movem ...[more]
Similar Datasets
Project description:Upper limb prostheses are specialized tools, and skilled operation is learned by amputees over time. Recently, neural prostheses using implanted peripheral nerve interfaces have enabled advances in artificial somatosensory feedback that can improve prosthesis outcomes. However, the effect of sensory learning on artificial somatosensation has not been studied, despite its known influence on intact somatosensation and analogous neuroprostheses. Sensory learning involves changes in the perception and interpretation of sensory feedback and may further influence functional and psychosocial outcomes. In this mixed methods case study, we examined how passive learning over 115 days of home use of a neural-connected, sensory-enabled prosthetic hand influenced perception of artificial sensory feedback in a participant with transradial amputation. We examined perceptual changes both within individual days of use and across the duration of the study. At both time scales, the reported percept locations became significantly more aligned with prosthesis sensor locations, and the phantom limb became significantly more extended toward the prosthesis position. Similarly, the participant's ratings of intensity, naturalness, and contact touch significantly increased, while his ratings of vibration and movement significantly decreased across-days for tactile channels. These sensory changes likely resulted from engagement of cortical plasticity mechanisms as the participant learned to use the artificial sensory feedback. We also assessed psychosocial and functional outcomes through surveys and interviews, and found that self-efficacy, perceived function, prosthesis embodiment, social touch, body image, and prosthesis efficiency improved significantly. These outcomes typically improved within the first month of home use, demonstrating rapid benefits of artificial sensation. Participant interviews indicated that the naturalness of the experience and engagement with the prosthesis increased throughout the study, suggesting that artificial somatosensation may decrease prosthesis abandonment. Our data showed that prosthesis embodiment was intricately related to naturalness and phantom limb perception, and that learning the artificial sensation may have modified the body schema. As another indicator of successfully learning to use artificial sensation, the participant reported the emergence of stereognosis later in the study. This study provides the first evidence that artificial somatosensation can undergo similar learning processes as intact sensation and highlights the importance of sensory restoration in prostheses.
| S-EPMC6712074 | biostudies-literature
Project description:Clinical myoelectric prostheses lack the sensory feedback and sufficient dexterity required to complete activities of daily living efficiently and accurately. Providing haptic feedback of relevant environmental cues to the user or imbuing the prosthesis with autonomous control authority have been separately shown to improve prosthesis utility. Few studies, however, have investigated the effect of combining these two approaches in a shared control paradigm, and none have evaluated such an approach from the perspective of neural efficiency (the relationship between task performance and mental effort measured directly from the brain). In this work, we analyzed the neural efficiency of 30 non-amputee participants in a grasp-and-lift task of a brittle object. Here, a myoelectric prosthesis featuring vibrotactile feedback of grip force and autonomous control of grasping was compared with a standard myoelectric prosthesis with and without vibrotactile feedback. As a measure of mental effort, we captured the prefrontal cortex activity changes using functional near infrared spectroscopy during the experiment. It was expected that the prosthesis with haptic shared control would improve both task performance and mental effort compared to the standard prosthesis. Results showed that only the haptic shared control system enabled users to achieve high neural efficiency, and that vibrotactile feedback was important for grasping with the appropriate grip force. These results indicate that the haptic shared control system synergistically combines the benefits of haptic feedback and autonomous controllers, and is well-poised to inform such hybrid advancements in myoelectric prosthesis technology.
| S-EPMC9832035 | biostudies-literature
Project description:Background: Peripheral neuropathy (PN) can result in either partial or complete loss of distal sensation resulting in an increased fall risk. Walkasins® uses a shoe insert to detect the magnitude and direction of sway and sends signals to a leg unit that provides sensory balance cues. The objective of this case report is to describe the long-term influence of the Walkasins® lower limb sensory neuroprosthesis on balance and gait for an individual with diabetic PN. Case Description: A 51-year-old male with a 3-year history of PN and a 10-year history of type II diabetes mellitus was fitted bilaterally with Walkasins® and utilized them 8-10 hours/day for more than 2 years. Although, vibration and tactile sensation thresholds were severely impaired at his 1st metatarsophalangeal joint and the lateral malleolus bilaterally he could perceive tactile stimuli from the Walkasins® above the ankles. Outcomes: Following Walkasins® use, his Activities-specific Balance Confidence Scale (ABC) scores improved from 33 to 80%. His mean Vestibular Activities of Daily Living (VADL) scores decreased from 3.54 to 1. His Functional Gait Assessment (FGA) scores increased from 13/30 to 28/30 and his miniBESTest scores improved from 15/28 to 26/28. Gait speed increased from 0.23 to 1.5 m/s. The patient described a decrease in pain and cramping throughout his lower extremities and an increase in function. Discussion: Gait and balance improved with the use of the Walkasins® and participation in a wellness program. This improvement suggests that the use of sensory substitution devices, such as the Walkasins®, may replace sensory deficits related to gait and balance dysfunction experienced by patients with PN. Further research is needed to determine if other patients will have a similar response and what the necessary threshold of sensory function is to benefit from use of the Walkasins®.
| S-EPMC8260940 | biostudies-literature
Project description:BackgroundAfter transfemoral amputation, many hours of practice are needed to re-learn walking with a prosthesis. The long adaptation process that consolidates a novel gait pattern seems to depend on cerebellar function for reinforcement of specific gait modifications, but the precise, step-by-step gait modifications (e.g., foot placement) most likely rely on top-down commands from the brainstem and cerebral cortex. The aim of this study was to identify, in able-bodied individuals, the specific modulations of cortical rhythms that accompany short-term gait modifications during first-time use of a dummy prosthesis.MethodsFourteen naïve participants walked on a treadmill without (one block, 4 min) and with a dummy prosthesis (three blocks, 3 × 4 min), while ground reaction forces and 32-channel EEG were recorded. Gait cycle duration, stance phase duration, step width, maximal ground reaction force and, ground reaction force trace over time were measured to identify gait modifications. Independent component analysis of EEG data isolated brain-related activity from distinct anatomical sources. The source-level data were segmented into gait cycles and analyzed in the time-frequency domain to reveal relative enhancement or suppression of intrinsic cortical oscillations. Differences between walking conditions were evaluated with one-way ANOVA and post-hoc testing (α = 0.05).ResultsImmediate modifications occurred in the gait parameters when participants were introduced to the dummy prosthesis. Except for gait cycle duration, these modifications remained throughout the duration of the experimental session. Power modulations of the theta, mu, beta, and gamma rhythms, of sources presumably from the fronto-central and the parietal cortices, were found across the experimental session. Significant power modulations of the theta, beta, and gamma rhythms within the gait cycle were predominately found around the heel strike of both feet and the swing phase of the right (prosthetic) leg.ConclusionsThe modulations of cortical activity could be related to whole-body coordination, including the swing phase and placing of the prosthesis, and the bodyweight transfer between legs and arms. Reduced power modulation of the gamma rhythm within the experimental session may indicate initial motor memories being formed. Better understanding of the sensorimotor processes behind gait modifications may inform the development of neurofeedback strategies to assist gait rehabilitation.
| S-EPMC7542708 | biostudies-literature
Project description:BACKGROUND:In people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface between residual limb and prosthetic socket, where the objectives of sufficient weight distribution and suspension are conflicting with the necessity to facilitate heat exchange and limit contact pressure and friction. Recently, prosthesis liners that contain phase-change material have become commercially available, holding the promise that the micro climate at the interface between the residual limb skin and the prosthetic socket can be regulated to reduce the users' tendency to sweat. Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners. However, the clinical relevance of those findings remains unclear. The purpose of this study is to investigate whether longer (6+ months) periods of use of phase-change material based temperature-control liners have clinically meaningful effects. METHODS:The protocol is a double-blind longitudinal cross-over research design. A sample of trans-tibial prosthesis users are wearing their regular gel or silicone liners for six months and phase-change material liners for another six months in a randomized sequence. Their prostheses is equipped with activity monitors to detect days when they could not wear their prosthesis. In six-week intervals, individuals' activity, physical performance, and overall prosthesis assessment is recorded using standardized methods. DISCUSSION:Expected results will inform prescription and reimbursement practice of phase-change material-based prosthesis liners and will help improve and economize prosthetic fitting for people with limb loss. The design and duration of the protocol, including randomization, blinding, and within-subject comparison, will generate scientific evidence of a comparably high level. Inclusion of a comparably large sample and different climates, e.g. across all four seasons, will make findings applicable to a large number of prosthesis users. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03428815. Registered on 12 February 2018.
| S-EPMC6954540 | biostudies-literature
Project description:BackgroundThe Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, California) is an epiretinal prosthesis that serves to provide useful vision to people who are affected by retinal degenerative diseases such as retinitis pigmentosa (RP). The purpose of this study was to analyze postoperative movement of the electrode array.MethodsFive patients diagnosed with profound retinal dystrophy who have undergone implantation of retinal prosthesis at Stony Brook University Hospital. Fundoscopy was performed at postoperative month 1 (M1), month 3 (M3), month 6 (M6), month 12 (M12), and month 24 (M24) visits. Fundoscopy was extracted and analyzed via NIH ImageJ. Data analysis was completed using IBM SPSS. Various lengths and angles were measured each postoperative month using ImageJ.ResultsThere was no significant change in distance between the optic disc and the surgical handle (length AB) over the two-year span (F = 0.196, p = 0.705). There was a significant change in distance of length AB over time between patients between M3 and M6 (p = 0.025). A repeated measures ANOVA revealed that there was statistically significant change of the optic disc-tack-surgical handle angle (𝛾) (M1 to M24) (F = 3.527, p = 0.030). There was no significant change in angle 𝜟 (the angle to the horizontal of the image), angle 𝜶 (tack-optic disc-surgical handle), and angle 𝜷 (optic-disc-surgical handle-tack).ConclusionOur results demonstrate that there may be postoperative movement of the retinal prosthesis over time, as a statistically significant downward rotation is reported over the 2 years span. It is important, moving forward, to further study this movement and to take into consideration such movement when designing retinal implants. It is important to note that this study is limited by the small sample size, and therefore, the conclusions drawn are limited.
| S-EPMC9933348 | biostudies-literature
Project description:Titanium undergoes time-dependent degradation in biological capability, or "biological aging". It is unknown whether the biological aging of titanium occurs beyond four weeks and whether age-related changes are definitely associated with surface hydrophilicity. We therefore measured multiple biological parameters of bone marrow-derived osteoblasts cultured on newly prepared, one-month-old, three-month-old, and six-month-old acid-etched titanium surfaces, as well as the hydrophilicity of these surfaces. New surfaces were superhydrophilic with a contact angle of ddH₂O of 0°, whereas old surfaces were all hydrophobic with the contact angle of around 90°. Cell attachment, cell spread, cell density, and alkaline phosphatase activity were highest on new surfaces and decreased in a time-dependent manner. These decreases persisted and remained significant for most of the biological parameters up to six-months. While the number of attached cells was negatively correlated with hydrophilicity, the other measured parameters were not. The biological capability of titanium continues to degrade up to six months of aging, but these effects are not directly associated with time-dependent reductions in hydrophilicity. A full understanding of the biological aging will help guide regulatory improvements in implant device manufacturing and develop countermeasures against this phenomenon in order to improve clinical outcomes.
| S-EPMC5456510 | biostudies-other
Project description:Introduction/aimLong-term efficacy and safety of dichlorphenamide (DCP) were characterized in patients with primary periodic paralysis (PPP).MethodsPatients with PPP in a double-blind, placebo-controlled study were randomly assigned to receive DCP 50 mg twice daily or placebo for 9 weeks, followed by a 52-week open-label DCP treatment phase (DCP/DCP and placebo/DCP populations). Efficacy (attack rate, severity-weighted attack rate) and safety were assessed in patients completing the study (61 weeks). In this post hoc analysis, efficacy and safety data were pooled from hyperkalemic and hypokalemic substudies.ResultsSixty-three adults (age, 19-76 years) completed the double-blind phase; 47 (74.6%) of these patients completed 61 weeks. There were median decreases in weekly attack and severity-weighted attack rates from baseline to week 61 (DCP/DCP [n = 25], -1.00 [P < .0001]; placebo/DCP [n = 20], -0.63 [P = .01] and DCP/DCP, -2.25 [P < .0001]; placebo/DCP, -1.69 [P = .01]). Relatively smaller median decreases in weekly attack and severity-weighted attack rates occurred from weeks 9 to 61 among patients receiving DCP continuously (n = 26; -0.14 [P = .1] and -0.24 [P = .09]) than among those switching from placebo to DCP after 9 weeks (n = 16; -1.04 [P = .049] and -2.72 [P = .08]). Common adverse events (AEs) were paresthesia and cognition-related events, which typically first occurred within 1 month of blinded treatment initiation and in rare cases led to treatment discontinuation. Dose reductions were frequently associated with common AE resolution.DiscussionOne-year open-label DCP treatment after a 9-week randomized, controlled study confirmed long-term DCP remains safe and effective for chronic use. Tolerability issues (paresthesia, cognition-related AEs) were manageable in most patients.
| S-EPMC9290603 | biostudies-literature
Project description: Not available
| S-EPMC8759487 | biostudies-literature
Project description:Classic galactosemia (CG) is a potentially lethal genetic disorder that results from profound deficiency of galactose-1-P uridylyltransferase. Despite early detection and life-long dietary restriction of galactose, which is the current standard of care, many patients with CG grow to experience a range of long-term developmental complications that can include difficulties with speech/voice/language, cognitive, motor, and psychosocial outcomes, among other problems. That these complications are common in CG is well-documented, but whether they are also progressive has been a point of controversy for decades. Here, we addressed the question of whether long-term outcomes in CG are progressive by analyzing a robust data set in each of 4 ways. First, we compared cross-sectional Vineland-3 Adaptive Behavior Scales scores for 101 cases and 65 unaffected sibling controls and found no evidence of consistently declining scores with age. Second, we analyzed longitudinal Vineland-3 subdomain scores for 45 cases and 34 controls to see if individual participants demonstrated developmental gains (positive slope) or losses (negative slope) over time. The changes in most growth scale value (GSV) scores, which are not normed, were positive for both cases and controls <10y, and either positive or near zero for participants ≥10y. In contrast, the slopes of most v-Scale scores, which are normed, were negative for many cases <10y, indicating that these children, while gaining milestones, were gaining them at a slower pace than their counterparts in the reference population. Third, we analyzed medical records from 76 cases, assigning ordinal scores for complications and gathering the quantitative results of relevant formal assessments where available. Both cross-sectional and longitudinal analyses of both ordinal and formal assessment scores confirmed that outcomes were mostly stable, albeit with some ups and downs in isolated cases. Finally, we analyzed data collected via custom family-response surveys from 124 cases and 67 controls regarding each participant's perceived symptom severity over time. Among cases, the percentages of respondents reporting worsening symptoms over time for speech, cognitive, motor, and psychosocial outcomes were 0.8%, 6.6%, 5.2%, and 9.8%, respectively. Among controls, the corresponding percentages were 0.0%, 1.5%, 1.5%, and 6.5%, respectively. These results provide compelling evidence that long-term developmental complications are not progressive for a majority of patients with CG.
| S-EPMC10842379 | biostudies-literature