Bioelectronic medicine最新文献

{"title":"Non-invasive vagus nerve stimulation: the future of inflammatory bowel disease treatment?","authors":"Bruno Bonaz","doi":"10.1186/s42234-023-00129-y","DOIUrl":"10.1186/s42234-023-00129-y","url":null,"abstract":"<p><p>The vagus nerve regulates inflammation and cytokine release through the inflammatory reflex. Recent pilot clinical trials using implantable bioelectronic devices have demonstrated the efficacy of vagus nerve stimulation (VNS) in adult patients with inflammatory bowel diseases (IBD) as an alternative to drug treatments. However, the use of non-invasive VNS should be of interest in adults with IBD and even more in pediatric IBD. In this issue of Bioelectronic Medicine, Sahn et al. report that non-invasive transcutaneous auricular VNS attenuated signs and symptoms in a pediatric cohort with mild to moderate IBD thus opening new therapeutic avenues in the management of pediatric but also adult IBD patients.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"26"},"PeriodicalIF":0.0,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10685668/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138453255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-invasive neuromodulation: an emerging intervention for visceral pain in gastrointestinal disorders.","authors":"Md Jahangir Alam, Jiande D Z Chen","doi":"10.1186/s42234-023-00130-5","DOIUrl":"10.1186/s42234-023-00130-5","url":null,"abstract":"<p><p>Gastrointestinal (GI) disorders, which extend from the esophagus to the anus, are the most common diseases of the GI tract. Among these disorders, pain, encompassing both abdominal and visceral pain, is a predominant feature, affecting the patients' quality of life and imposing a substantial financial burden on society. Pain signals originating from the gut intricately shape brain dynamics. In response, the brain sends appropriate descending signals to respond to pain through neuronal inhibition. However, due to the heterogeneous nature of the disease and its limited pathophysiological understanding, treatment options are minimal and often controversial. Consequently, many patients with GI disorders use complementary and alternative therapies such as neuromodulation to treat visceral pain. Neuromodulation intervenes in the central, peripheral, or autonomic nervous system by alternating or modulating nerve activity using electrical, electromagnetic, chemical, or optogenetic methodologies. Here, we review a few emerging noninvasive neuromodulation approaches with promising potential for alleviating pain associated with functional dyspepsia, gastroparesis, irritable bowel syndrome, inflammatory bowel disease, and non-cardiac chest pain. Moreover, we address critical aspects, including the efficacy, safety, and feasibility of these noninvasive neuromodulation methods, elucidate their mechanisms of action, and outline future research directions. In conclusion, the emerging field of noninvasive neuromodulation appears as a viable alternative therapeutic avenue for effectively managing visceral pain in GI disorders.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"27"},"PeriodicalIF":0.0,"publicationDate":"2023-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10664460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138292548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rib detection using pitch-catch ultrasound and classification algorithms for a novel ultrasound therapy device.","authors":"Claire R W Kaiser, Adam B Tuma, Maryam Zebarjadi, Daniel P Zachs, Anna J Organ, Hubert H Lim, Morgan N Collins","doi":"10.1186/s42234-023-00127-0","DOIUrl":"10.1186/s42234-023-00127-0","url":null,"abstract":"<p><strong>Background: </strong>Noninvasive ultrasound (US) has been used therapeutically for decades, with applications in tissue ablation, lithotripsy, and physical therapy. There is increasing evidence that low intensity US stimulation of organs can alter physiological and clinical outcomes for treatment of health disorders including rheumatoid arthritis and diabetes. One major translational challenge is designing portable and reliable US devices that can be used by patients in their homes, with automated features to detect rib location and aid in efficient transmission of energy to organs of interest. This feasibility study aimed to assess efficacy in rib bone detection without conventional imaging, using a single channel US pitch-catch technique integrated into an US therapy device to detect pulsed US reflections from ribs.</p><p><strong>Methods: </strong>In 20 healthy volunteers, the location of the ribs and spleen were identified using a diagnostic US imaging system. Reflected ultrasound signals were recorded at five positions over the spleen and adjacent ribs using the therapy device. Signals were classified as between ribs (intercostal), partially over a rib, or fully over a rib using four models: threshold-based time domain classification, threshold-based frequency domain classification, logistic regression, and support vector machine (SVM).</p><p><strong>Results: </strong>SVM performed best overall on the All Participants cohort with accuracy up to 96.25%. All models' accuracies were improved by separating participants into two cohorts based on Body Mass Index (BMI) and re-fitting each model. After separation into Low BMI and High BMI cohorts, a simple time-thresholding approach achieved accuracies up to 100% and 93.75%, respectively.</p><p><strong>Conclusion: </strong>These results demonstrate that US reflection signal classification can accurately provide low complexity, real-time automated onboard rib detection and user feedback to advance at-home therapeutic US delivery.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"25"},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10647025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107593014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gateway reflexes describe novel neuro-immune communications that establish immune cell gateways at specific vessels.","authors":"Hiroki Tanaka, Rie Hasebe, Kaoru Murakami, Toshiki Sugawara, Takeshi Yamasaki, Masaaki Murakami","doi":"10.1186/s42234-023-00126-1","DOIUrl":"10.1186/s42234-023-00126-1","url":null,"abstract":"<p><p>Neuroinflammation is an important biological process induced by complex interactions between immune cells and neuronal cells in the central nervous system (CNS). Recent research on the bidirectional communication between neuronal and immunological systems has provided evidence for how immune and inflammatory processes are regulated by nerve activation. One example is the gateway reflex, in which immune cells bypass the blood brain barrier and infiltrate the CNS to cause neuroinflammation. We have found several modes of the gateway reflex in mouse models, in which gateways for immune cells are established at specific blood vessels in the spinal cords and brain in experimental autoimmune encephalomyelitis and systemic lupus erythematosus models, at retinal blood vessels in an experimental autoimmune uveitis model, and the ankle joints in an inflammatory arthritis model. Several environmental stimulations, including physical and psychological stresses, activate neurological pathways that alter immunological responses via the gateway reflex, thus contributing to the development/suppression of autoimmune diseases. In the manuscript, we describe the discovery of the gateway reflex and recent insights on how they regulate disease development. We hypothesize that artificial manipulation of specific neural pathways can establish and/or close the gateways to control the development of autoimmune diseases.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"24"},"PeriodicalIF":0.0,"publicationDate":"2023-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10631009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71489540","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy.","authors":"Gen Miura, Tadami Fujiwara, Yoshihito Ozawa, Yuki Shiko, Yohei Kawasaki, Tomohiro Nizawa, Tomoaki Tatsumi, Takuji Kurimoto, Sotaro Mori, Makoto Nakamura, Hideki Hanaoka, Takayuki Baba, Shuichi Yamamoto","doi":"10.1186/s42234-023-00125-2","DOIUrl":"10.1186/s42234-023-00125-2","url":null,"abstract":"<p><strong>Background: </strong>No effective treatment for NAION with strong evidence has been established till date. The aim of this investigator-led, prospective, non-randomized, open-label, uncontrolled multi-center exploratory clinical trial is to evaluate the efficacy and safety of transdermal electrical stimulation (TdES) using skin electrodes in patients with NAION.</p><p><strong>Methods: </strong>Five patients with monocular NAION underwent TdES (10-ms biphasic pulses, 1.0 mA, 20 Hz, 30 min) of the affected eye six times at 2-week intervals. The primary endpoint was the logarithm of the mini-mum angle of resolution (logMAR) visual acuity at 12 weeks compared with 0 weeks. The secondary endpoints were changes in the best-corrected logMAR visual acuity, Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity, and mean deviation (MD) of the Humphrey field analyzer (HFA) 10-2 and HFA Esterman test scores. Additionally, the safety of TdES was evaluated.</p><p><strong>Results: </strong>LogMAR visual acuity improved by ≥ 0.1 in two eyes, and ETDRS visual acu-ity improved by ≥ 5 characters in one eye. The mean change in logMAR visual acuity from week 0 showed an increasing trend. The mean MD of HFA 10-2 showed no obvious change, while HFA Esterman score improved in four eyes. All patients completed the study according to the protocol, and no treatment-related adverse events were observed.</p><p><strong>Conclusions: </strong>TdES treatment may have improved visual acuity and visual field in some patients. Further sham-controlled study in larger cohort is needed on its effectiveness.</p><p><strong>Trial registration: </strong>UMIN, UMIN000036220. Registered 15 March, 2019, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041261 .</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"22"},"PeriodicalIF":0.0,"publicationDate":"2023-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10598888/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50159455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcutaneous auricular vagus nerve stimulation attenuates inflammatory bowel disease in children: a proof-of-concept clinical trial.","authors":"Benjamin Sahn, Kristine Pascuma, Nina Kohn, Kevin J Tracey, James F Markowitz","doi":"10.1186/s42234-023-00124-3","DOIUrl":"10.1186/s42234-023-00124-3","url":null,"abstract":"<p><strong>Background: </strong>Vagus nerve stimulation is an investigational anti-inflammatory therapy targeting the nervous system to modulate immune activity. This study evaluated the efficacy and safety of transcutaneous auricular VNS (ta-VNS) in patients with pediatric-onset Crohn's disease (CD) or ulcerative colitis (UC).</p><p><strong>Methods: </strong>Participants were 10-21 years of age with mild/moderate CD or UC and fecal calprotectin (FC) > 200 ug/g within 4 weeks of study entry. Subjects were randomized to receive either ta-VNS targeting the cymba conchae of the external left ear, or sham stimulation, of 5 min duration once daily for a 2-week period, followed by a cross over to the alternative stimulation for an additional 2 weeks. At week 4, all subjects received ta-VNS of 5 min duration twice daily until week 16. Primary study endpoints were clinical remission, and a ≥ 50% reduction in FC level from baseline to week 16. Heart rate variability measurements and patient-reported outcome questionnaires were completed during interval and week 16 assessments.</p><p><strong>Results: </strong>Twenty-two subjects were enrolled and analyzed (10 CD, 12 UC). Six of 10 with CD had a wPCDAI > 12.5 and 6/12 with UC had a PUCAI > 10 at baseline, correlating to mild to moderate symptom activity. Among the 12 subjects with active symptomatic disease indices at baseline, clinical remission was achieved in 3/6 (50%) with CD and 2/6 (33%) with UC at week 16. Despite all subjects having FC levels ≥ 200 within 4 weeks of enrollment, five subjects (4 UC, 1 CD) had FC levels < 200 at the baseline visit and were excluded from the FC analysis. Of the remaining 17, median baseline FC was 907 µg/g (IQR 411-2,120). At week 16, 11/17 (64.7%) of those with baseline FC ≥ 200 had a ≥ 50% reduction in FC (95% CI 38.3-85.8). In the UC subjects, there was an 81% median reduction in FC vs baseline (833 µg/g; p = 0.03) while in the CD subjects, median reduction in FC at 16 weeks was 51% (357 µg/g; p = 0.09). There were no safety concerns.</p><p><strong>Conclusion: </strong>Noninvasive ta-VNS attenuated signs and symptoms in a pediatric cohort with mild to moderate inflammatory bowel disease.</p><p><strong>Trial registration: </strong>NCT03863704-Date of registration 3/4/2019.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"23"},"PeriodicalIF":0.0,"publicationDate":"2023-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10583463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41241521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Fifth Bioelectronic Medicine Summit: today's tools, tomorrow's therapies.","authors":"Eric H Chang, Arielle H Gabalski, Tomas S Huerta, Timir Datta-Chaudhuri, Theodoros P Zanos, Stavros Zanos, Warren M Grill, Kevin J Tracey, Yousef Al-Abed","doi":"10.1186/s42234-023-00123-4","DOIUrl":"10.1186/s42234-023-00123-4","url":null,"abstract":"<p><p>The emerging field of bioelectronic medicine (BEM) is poised to make a significant impact on the treatment of several neurological and inflammatory disorders. With several BEM therapies being recently approved for clinical use and others in late-phase clinical trials, the 2022 BEM summit was a timely scientific meeting convening a wide range of experts to discuss the latest developments in the field. The BEM Summit was held over two days in New York with more than thirty-five invited speakers and panelists comprised of researchers and experts from both academia and industry. The goal of the meeting was to bring international leaders together to discuss advances and cultivate collaborations in this emerging field that incorporates aspects of neuroscience, physiology, molecular medicine, engineering, and technology. This Meeting Report recaps the latest findings discussed at the Meeting and summarizes the main developments in this rapidly advancing interdisciplinary field. Our hope is that this Meeting Report will encourage researchers from academia and industry to push the field forward and generate new multidisciplinary collaborations that will form the basis of new discoveries that we can discuss at the next BEM Summit.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"21"},"PeriodicalIF":0.0,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10552422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41175222","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Wireless agents for brain recording and stimulation modalities.","authors":"Ilhan Bok, Adam Vareberg, Yash Gokhale, Suyash Bhatt, Emily Masterson, Jack Phillips, Tianxiang Zhu, Xiaoxuan Ren, Aviad Hai","doi":"10.1186/s42234-023-00122-5","DOIUrl":"10.1186/s42234-023-00122-5","url":null,"abstract":"<p><p>New sensors and modulators that interact wirelessly with medical modalities unlock uncharted avenues for in situ brain recording and stimulation. Ongoing miniaturization, material refinement, and sensitization to specific neurophysiological and neurochemical processes are spurring new capabilities that begin to transcend the constraints of traditional bulky and invasive wired probes. Here we survey current state-of-the-art agents across diverse realms of operation and evaluate possibilities depending on size, delivery, specificity and spatiotemporal resolution. We begin by describing implantable and injectable micro- and nano-scale electronic devices operating at or below the radio frequency (RF) regime with simple near field transmission, and continue with more sophisticated devices, nanoparticles and biochemical molecular conjugates acting as dynamic contrast agents in magnetic resonance imaging (MRI), ultrasound (US) transduction and other functional tomographic modalities. We assess the ability of some of these technologies to deliver stimulation and neuromodulation with emerging probes and materials that provide minimally invasive magnetic, electrical, thermal and optogenetic stimulation. These methodologies are transforming the repertoire of readily available technologies paired with compatible imaging systems and hold promise toward broadening the expanse of neurological and neuroscientific diagnostics and therapeutics.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"20"},"PeriodicalIF":0.0,"publicationDate":"2023-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10510192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41173384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impaired parasympathetic function in long-COVID postural orthostatic tachycardia syndrome - a case-control study.","authors":"Stefano Rigo, Vasile Urechie, Andrè Diedrich, Luis E Okamoto, Italo Biaggioni, Cyndya A Shibao","doi":"10.1186/s42234-023-00121-6","DOIUrl":"10.1186/s42234-023-00121-6","url":null,"abstract":"<p><strong>Purpose: </strong>Eighty percent of patients infected by SARS-CoV-2 report persistence of one symptom beyond the 4-week convalescent period. Those with orthostatic tachycardia and orthostatic symptoms mimicking postural tachycardia syndrome, they are defined as Long-COVID POTS [LCP]. This case-control study investigated potential differences in autonomic cardiovascular regulation between LCP patients and healthy controls.</p><p><strong>Methods: </strong>Thirteen LCP and 16 healthy controls, all female subjects, were studied without medications. Continuous blood pressure and ECG were recorded during orthostatic stress test, respiratory sinus arrhythmia, and Valsalva maneuver. Time domain and power spectral analysis of heart rate [HR] and systolic blood pressure [SBP] variability were computed characterizing cardiac autonomic control and sympathetic peripheral vasoconstriction.</p><p><strong>Results: </strong>LCP had higher deltaHR (+ 40 ± 6 vs. + 21 ± 3 bpm, p = 0.004) and deltaSBP (+ 8 ± 4 vs. -1 ± 2 mmHg, p = 0.04) upon standing; 47% had impaired Valsalva maneuver ratio compared with 6.2% in controls (p = 0.01). Spectral analysis revealed that LCP had lower RMSSD (32.1 ± 4.6 vs. 48.9 ± 6.8 ms, p = 0.04) and HF_RRI, both in absolute (349 ± 105 vs. 851 ± 253ms², p = 0.03) and normalized units (32 ± 4 vs. 46 ± 4 n.u., p = 0.02). LF_SBP was similar between groups.</p><p><strong>Conclusions: </strong>LCP have reduced cardiovagal modulation, but normal sympathetic cardiac and vasoconstrictive functions. Impaired parasympathetic function may contribute to the pathogenesis of Long-COVID POTS syndrome.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"19"},"PeriodicalIF":0.0,"publicationDate":"2023-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10481607/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10177788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Obstructive sleep apnea improves with non-invasive hypoglossal nerve stimulation using temporal interference.","authors":"Florian Missey, Malin Silverå Ejneby, Ibrahima Ngom, Mary J Donahue, Jan Trajlinek, Emma Acerbo, Boris Botzanowski, Antonino M Cassarà, Esra Neufeld, Eric D Glowacki, Lee Shangold, William M Hanes, Adam Williamson","doi":"10.1186/s42234-023-00120-7","DOIUrl":"10.1186/s42234-023-00120-7","url":null,"abstract":"<p><strong>Background: </strong>Peripheral nerve stimulation is used in both clinical and fundamental research for therapy and exploration. At present, non-invasive peripheral nerve stimulation still lacks the penetration depth to reach deep nerve targets and the stimulation focality to offer selectivity. It is therefore rarely employed as the primary selected nerve stimulation method. We have previously demonstrated that a new stimulation technique, temporal interference stimulation, can overcome depth and focality issues.</p><p><strong>Methods: </strong>Here, we implement a novel form of temporal interference, bilateral temporal interference stimulation, for bilateral hypoglossal nerve stimulation in rodents and humans. Pairs of electrodes are placed alongside both hypoglossal nerves to stimulate them synchronously and thus decrease the stimulation amplitude required to activate hypoglossal-nerve-controlled tongue movement.</p><p><strong>Results: </strong>Comparing bilateral temporal interference stimulation with unilateral temporal interference stimulation, we show that it can elicit the same behavioral and electrophysiological responses at a reduced stimulation amplitude. Traditional transcutaneous stimulation evokes no response with equivalent amplitudes of stimulation.</p><p><strong>Conclusions: </strong>During first-in-man studies, temporal interference stimulation was found to be well-tolerated, and to clinically reduce apnea-hypopnea events in a subgroup of female patients with obstructive sleep apnea. These results suggest a high clinical potential for the use of temporal interference in the treatment of obstructive sleep apnea and other diseases as a safe, effective, and patient-friendly approach.</p><p><strong>Trial registration: </strong>The protocol was conducted with the agreement of the International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States Code of Federal Regulations (CFR) and followed the approved BRANY IRB File # 22-02-636-1279.</p>","PeriodicalId":72363,"journal":{"name":"Bioelectronic medicine","volume":"9 1","pages":"18"},"PeriodicalIF":0.0,"publicationDate":"2023-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10410873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10325372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}