Harnessing novel data sources to understand patients’ perspectives (Preprint)

UNSTRUCTURED Patient perspectives are central to the U.S. Food and Drug Administration’s benefit-risk decision-making process in the evaluation of medical products. Traditional channels of communication may not be comfortable for all patients and consumers. Social media websites have increasingly been recognized by researchers as a means to gain insights on patients’ views about treatment and diagnostic options, the healthcare system, and their experiences living with their conditions. Utilizing multiple patient perspective data sources offers the FDA the opportunity to capture diverse patient voices and experiences with chronic pain. The FDA Office of Minority Health and Health Equity (OMHHE) and the Center for Devices and Radiological Health (CDRH) worked with INSPIRE (Clinica Health, Inc.) to conduct a pilot study exploring posts from INSPIRE’s own patient platform and several social media platforms to gain insights into the key challenges and barriers faced by chronic pain patients (CPPs). The most common topics discussed among CPPs were disease burden, support and advocacy needs, and proper diagnosis. The two most frequently discussed treatments were opioids or narcotics, and devices such as transcutaneous electrical nerve stimulation (TENS) machines and spinal cord stimulators. Success in pain reduction was tempered by concerns of stigmatization regarding opioid addiction and dependency. The study illustrates how social listening data may provide valuable insights into diverse patient perspectives, preferences, and unmet needs, especially for conditions that may be perceived as stigmatizing.

Recognizing Full-Body Exercise Execution Errors Using the Teslasuit

Regular physical exercise is essential for overall health; however, it is also crucial to mitigate the probability of injuries due to incorrect exercise executions. Existing health or fitness applications often neglect accurate full-body motion recognition and focus on a single body part. Furthermore, they often detect only specific errors or provide feedback first after the execution. This lack raises the necessity for the automated detection of full-body execution errors in real-time to assist users in correcting motor skills. To address this challenge, we propose a method for movement assessment using a full-body haptic motion capture suit. We train probabilistic movement models using the data of 10 inertial sensors to detect exercise execution errors. Additionally, we provide haptic feedback, employing transcutaneous electrical nerve stimulation immediately, as soon as an error occurs, to correct the movements. The results based on a dataset collected from 15 subjects show that our approach can detect severe movement execution errors directly during the workout and provide haptic feedback at respective body locations. These results suggest that a haptic full-body motion capture suit, such as the Teslasuit, is promising for movement assessment and can give appropriate haptic feedback to the users so that they can improve their movements.

Gambaran Peningkatan Fungsional Pasien Bell’s Palsy Setelah Pemberian Kombinasi Transcutaneous Electrical Nerve Stimulation (Tens) Dan Exercise : Literature Review

Bell's palsy is an acute weakness or paralysis of the peripheral facial nerve with no known cause. The incidence of Bell's palsy is about 40-70% of all acute peripheral facial nerve palsy, the average prevalence ranges from 10-30% per 100,000 population per year) Data collected from 4 hospitals in Indonesia shows that the frequency of Bell's palsy shows 19.55% of all cases of neuropathy. The incidence of Bell's palsy ranges from 23 cases per 100,000 people annually, most of the cases 85 % cured within 1-2 months which occurs in 8% of cases. The literature Review research is to analyze the description of the functional improvement of Bell's Palsy patients after the combination of Transcutaneous Electrical Nerve Stimulation (TENS) and Exercise. The selection of articles in this study used the PICO mnemonic design. 160 reviewed articles via PubMed and google scholar, article search via PubMed (1), Google Scholar (4). Inclusion and exclusion criteria according to keywords, published in 2010-2021. The results of the analysis of the literature review of 5 articles showed that the male gender was at risk of experiencing Bell's palsy, namely 29 (52.7%) compared to the female sex, which was 26 (47.3%). Functional recovery in Bell's palsy from the mean pre-test and post-test scores, it can be seen that the average pre-test is 5.19 and the average post-test is 3.65. Improved functional recovery in Bell's palsy patients after administering TENS with a combination of Exercise with massage methods.Keywords: Bell’s palsy, TENS and Massage AbstrakBell's palsy adalah kelemahan akut atau kelumpuhan saraf wajah perifer tanpa diketahui penyebabnya. Kejadian Bell's palsy sekitar 40-70% dari seluruh kelumpuhan saraf fasialis perifer akut, prevalensi rata-rata berkisar 10-30% per 100.000 penduduk per tahun) Data yang dikumpulkan dari 4 rumah sakit di Indonesia menunjukkan bahwa frekuensi Bell's palsy menunjukkan 19,55 % dari semua kasus neuropati. Angka kejadian Bell's palsy berkisar 23 kasus per 100.000 orang setiap tahunnya, sebagian besar 85% sembuh dalam waktu 1-2 bulan yang terjadi pada 8% kasus. Penelitian Literatur Review ini untuk menganalisis gambaran peningkatan fungsional pasien Bell's Palsy setelah pemberian kombinasi Transcutaneous Electrical Nerve Stimulation (TENS) dan Latihan. Pemilihan artikel dalam penelitian ini menggunakan desain mnemonic PICO. 160 artikel yang diulas melalui PubMed dan google sarjana, pencarian artikel melalui PubMed (1), Google Cendekia (4). Kriteria inklusi dan eksklusi menurut kata kunci, terbit tahun 2010-2021. Hasil analisis literature review dari 5 artikel menunjukkan bahwa jenis kelamin laki-laki berisiko mengalami Bell’s palsy yaitu 29 (52,7%) dibandingkan dengan jenis kelamin perempuan, yaitu 26 (47,3%). Pemulihan fungsional pada Bell's palsy dari rerata skor pre-test dan post-test, terlihat bahwa rata-rata pre-test adalah 5,19 dan rata-rata post-test adalah 3,65. Peningkatan pemulihan fungsional pada pasien Bell's palsy setelah pemberian TENS dengan kombinasi Latihan dengan metode pijat.Kata kunci: Bell’s palsy, TENS dan pijat

Determination of Current Flow Induced by Transcutaneous Electrical Nerve Stimulation for the Treatment of Migraine: Potential for Optimization

Introduction: Transcutaneous electrical nerve stimulation (TENS) for migraine involves the application of pulsatile stimulation through electrodes placed on the forehead to target the underlying trigeminal nerves. It is a simple, safe modality and has secured clinical approval in several markets including the European Union and the United States. Despite nearing almost 7 years of use (postclinical approval), the exact mechanism of action is not fully known. Guided by the need to stimulate the trigeminal nerves bilaterally, electrode dimensions are simply required to extend enough to cover the underlying nerves. The goal of this study is to examine induced current flow [magnitude and spatial distribution of electric field (EF)] and another driver of stimulation [activating function (AF)] due to TENS therapy for migraine for the first time. We further consider the effect of changing the electrode dimension and shape and propose a design modification to deliver optimal flow.Methods: We developed the first ultra-high-resolution finite element (FE) model of TENS for migraine incorporating the target supratrochlear (ST) and the supraorbital (SO) nerves. We first simulated the clinically approved V-shaped geometry. We then considered three additional designs: extended V-shaped, idealized pill-shaped, and finally an extended V-shaped but with greater contact spacing (extended V-shaped +CS).Results: Our findings revealed that the clinically approved electrode design delivered substantially higher mean current flow to the ST nerve in comparison with the SO nerves (Medial: 53% and Lateral: 194%). Consideration of an extended design (~10 mm longer and ~ 4 mm shorter) and a pill-like design had negligible impact on the induced current flow pattern. The extended V-shaped +CS montage delivered relatively comparable current flow to each of the three target nerves. The EF induced in the ST nerve was 49 and 141% higher in the Medial and Lateral SO nerve, respectively. When considering maximum induced values, the delivery of comparable stimulation was further apparent. Given the existing electrode design's established efficacy, our results imply that preferential targeting of the ST nerve is related to the mechanism of action. Additionally, if comparable targeting of all three nerves continues to hold promise, the extended V-shaped +CS montage presents an optimized configuration to explore in clinical studies.

Relationship between high-frequency activity in the sensory and the motor hand areas, and regional myelin content

BackgroundThe human primary sensory (S1) and primary motor (M1) hand areas feature high-frequency neuronal responses. Electrical nerve stimulation evokes high-frequency oscillations (HFO) at around 650 Hz in the contralateral S1. Likewise, paired-pulse transcranial magnetic stimulation of M1 produces short interval intracortical facilitation (SICF) of motor evoked potentials in contralateral hand muscles. SICF features several peaks of facilitation which are separated by inter-peak intervals resembling HFO rhythmicity.HypothesisIn this study, we tested the hypothesis that the individual expressions of HFO and SICF are tightly related to each other and to the regional myelin content in the sensorimotor cortex.MethodsIn 24 healthy volunteers, we recorded HFO and SICF, and, in a subgroup of 20 participants, we mapped the cortical myelin content using the ratio between the T1- and T2-weighted MRI signal as read-out.ResultsThe individual frequencies and magnitudes of HFO and SICF were tightly correlated: the intervals between the first and second peak of cortical HFO and SICF showed a positive linear relationship (r= 0.703, p< 0.001), while their amplitudes were inversely related (r= −0.613, p= 0.001). The rhythmicity, but not the magnitude of the high-frequency responses, was related to the cortical myelin content: the higher the cortical myelin content, the shorter the inter-peak intervals of HFO and SICF.ConclusionThe results confirm a tight functional relationship between high-frequency responses in S1 (i.e., HFO) and M1 (i.e., SICF). They also establish a link between the degree of regional cortical myelination and the expression of high-frequency responses in the human cortex, giving further the opportunity to infer their possible generators.

Bilateral Transcutaneous Electrical Nerve Stimulation Improves Upper Limb Motor Recovery in Stroke: A Randomized Controlled Trial

Background and Purpose: Recent evidence has shown bilateral transcutaneous electrical nerve stimulation (Bi-TENS) combined with task-oriented training (TOT) to be superior to unilateral transcutaneous electrical nerve stimulation (Uni-TENS)+TOT in improving lower limb motor functioning following stroke. However, no research explored the effect of Bi-TENS+TOT in improving upper limb motor recovery. This study aimed to compare Bi-TENS+TOT with Uni-TENS+TOT, Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)+TOT, and no treatment (Control) groups in upper limb motor recovery. Methods: This is a 4-group parallel design. One hundred and twenty subjects were given either Bi-TENS+TOT, Uni-TENS+TOT, Placebo-TENS+TOT, or Control without treatment in this randomized controlled trial. Twenty 60-minute sessions were administered 3× per week for 7 weeks. The outcome measure was the Fugl-Meyer Assessment of Upper Extremity, which was assessed at baseline, after 10 sessions (mid-intervention) and 20 sessions (post-intervention) of intervention, and at 1- and 3-month follow-up. Results: Patients in the Bi-TENS+TOT group showed greater improvement in the Fugl-Meyer Assessment of Upper Extremity scores than Uni-TENS+TOT (mean difference, 2.13; P =0.004), Placebo-TENS+TOT (mean difference, 2.63; P <0.001), and Control groups (mean difference, 3.11; P <0.001) at post-intervention. Both Bi-TENS+TOT (mean difference, 3.39; P <0.001) and Uni-TENS+TOT (mean difference, 1.26; P =0.018) showed significant within-group improvement in the Fugl-Meyer Assessment of Upper Extremity scores. Patients in the Bi-TENS+TOT group showed earlier within-group improvement in the Fugl-Meyer Assessment of Upper Extremity scores at mid-intervention than Uni-TENS+TOT. These improvements were maintained at the 3-month follow-up assessment. Conclusions: Bi-TENS combined with TOT is an effective therapy for improving upper limb motor recovery following stroke. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03112473.