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In this randomized, sham-controlled trial, MRI-guided focused ultrasound thalamotomy reduced hand tremor in patients with essential tremor who had not had a response to medication. Adverse effects of the procedure included sensory deficits and gait disturbances. Essential tremor, the most common movement disorder, 1 is characterized by a distinctive postural and intention tremor typically affecting the hands more than the legs, trunk, head, or voice. 2 , 3 Essential tremor does not shorten life expectancy, but it can affect quality of life, functional activities, mood, and socialization. 4 – 6 Class I evidence exists for propranolol and primidone as first-line medications that reduce tremor by approximately 60% in 50% of patients. 7 – 11 If resistance to medications develops or side effects are unacceptable, neurosurgical intervention is considered, primarily targeting the nucleus ventralis intermedius of the thalamus, a component of tremor circuitry that . . .

In an uncontrolled, open-label pilot study, essential tremor improved in 15 patients treated with MRI-guided focused ultrasound thalamotomy. Adverse effects included persistent paresthesias in four patients. The study was too small to assess the safety of this procedure. Essential tremor, the most common movement disorder, with a prevalence as high as 4%, is characterized by a rhythmic oscillation of agonist and antagonist muscle groups, typically between 8 and 12 Hz. 1 The cause of this disorder remains unknown, although there is often a familial component with a link to a particular polymorphism in the gene encoding leucine-rich repeat and immunoglobulin domain–containing protein 1 ( LINGO1 ). Although essential tremor is not medically dangerous, it is progressive and disabling in the home and workplace. 2 The degree of tremor does not always correlate with the severity of disability, 3 and patients with . . .

AbstractObjectiveTo evaluate the effectiveness and safety of sonolysis using a low intensity 2 MHz pulsed wave ultrasound beam during carotid endarterectomy.DesignMulticentre, phase 3, double blind, randomised controlled trial.Setting16 European centres.Participants1004 patients (mean age 68 years; 312 (31%) female) were enrolled in the study between 20 August 2015 and 14 October 2020 until the interim analysis was performed.InterventionsSonolysis (n=507) versus sham procedure (n=497).Main outcome measuresThe primary endpoint was the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days. The incidence of new ischaemic lesions on follow-up brain magnetic resonance imaging was the main substudy endpoint, and incidence of intracranial bleeding was the main safety endpoint.ResultsThe results favoured the sonolysis group for the primary endpoint (11 (2.2%) v 38 (7.6%); risk difference −5.5%, 95% confidence interval (CI) −8.3% to −2.8%; P<0.001), as well as in the substudy for magnetic resonance imaging detected new ischaemic lesions (20/236 (8.5%) v 39/224 (17.4%); risk difference −8.9%, −15% to −2.8%; P=0.004). Sensitivity analysis resulted in a risk ratio for sonolysis of 0.25 (95% CI 0.11 to 0.56) for ischaemic stroke and 0.23 (0.07 to 0.73) for transient ischaemic attack within 30 days. Sonolysis was found to be safe, and 94.4% of patients in the sonolysis group were free from serious adverse events 30 days after the procedure.ConclusionSonolysis was safe for patients undergoing carotid endarterectomy and resulted in a significant reduction in the composite incidence of ischaemic stroke, transient ischaemic attack, and death within 30 days.Trial registrationClinicaltrials.gov NCT02398734.

Background With the aging population, the demand for skin anti‐aging treatments has been steadily rising, prompting the development of advanced non‐invasive therapies. Aims To evaluate the efficacy and safety of microfocused ultrasound (MFU) combined with microneedle fractional radiofrequency (MFR) for facial rejuvenation. Methods This study involved 26 patients experiencing facial laxity. Each patient received one full‐face MFU treatment and one MFR treatment on one side of the face, which was randomly assigned. All treatments were performed on the same day. Facial photoaging parameters were assessed using VISIA, skin fat thickness changes were measured via ultrasound, and subjective evaluations were recorded at Months 0, 1, and 3. Side effects were recorded during treatments and each follow‐up visit. Results The VISIA analysis demonstrated notable enhancements in skin texture, wrinkles, pores, spots, and red areas on the combined treatment side. Ultrasound examinations revealed a significant reduction in subcutaneous fat thickness, particularly at the masseter and the middle of the cheek on the combined side. The study showed improvements in the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS) scores, with the combined treatment side outperforming the control side at the 3 month mark. Over 90% of participants expressed satisfaction with the treatment outcomes. Mild side effects, such as erythema, purpura, and edema, were observed but resolved without special interventions. Conclusions The combination of MFU and MFR for facial rejuvenation is both safe and effective. The combined treatment demonstrates superior enhancement in skin tightening, depigmentation, and pore refinement within a single therapeutic session.

Objective. Studies regarding the combination of ultrasound and transcutaneous electrical nerve stimulation (TENS) are rarely reported. In this study, we aimed to elucidate the efficacy and safety of a stimulator using low-intensity pulsed ultrasound (LIPUS) combined with TENS in patients with painful knee osteoarthritis (OA). We evaluated the effectiveness of this therapy against pain, physical function, and cartilage regeneration. Moreover, we aim to prove the superiority of the effects of LIPUS combined with TENS therapy compared with only TENS therapy. Methods. Of the 40 included patients, aged 45–85 years with painful knee OA, 20 patients received only TENS therapy and 20 patients received LIPUS combined with TENS therapy for 8 weeks (a total of more than 80 treatment sessions). We evaluated visual analogue scale (VAS), Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, MOS 36-Item Short-Form Health Survey (SF-36), and femoral articular cartilage (FAC) thickness. The evaluation was performed at three visits: visit 1 (V1, pretreatment, within 28 days after screening), visit 2 (V2, posttreatment period 1, ±3 days after treatment), and visit 3 (V3, posttreatment period 2, 21 ± 3 days after treatment). Results. We expected that LIPUS combined with TENS therapy would be superior to only TENS therapy. However, there was no significant difference between the two therapies. In the within-group comparison, both treatments (only TENS therapy and LIPUS with TENS therapy) demonstrated statistical differences from baseline values for pain and physical function outcomes. FAC thickness showed no significant differences after treatment in both groups. Conclusion. The effects of a stimulator using LIPUS with TENS on pain relief and functional improvement were not superior to the only TENS therapy. Cartilage regeneration, which was expected as an additional benefit of LIPUS, was also not significantly evident. Therefore, further investigation is warranted to determine whether the combination therapy is beneficial. This trial is registered with KCT0003883.

The aim of this study was to investigate the effects of focused low-intensity pulsed ultrasound (FLIPUS) therapy on the functional and health status of patients with knee osteoarthritis (KOA). A total of 106 subjects with bilateral KOA were randomized sequentially into two groups. Group I received FLIPUS + diclofenac sodium, and group II received sham FLIPUS + diclofenac sodium. The therapeutic effects of the interventions were evaluated by measuring changes in VAS pain, the WOMAC scores, and the LI scores after 10 days of treatment as well as changes in LI and VAS at follow-up, 4 and 12 weeks later. In addition, changes in the range of motion, ambulation speed, and the SF-36 in each group were recorded after 10 days of treatment. Compared with those in group II, patients in group Ishowed significant improvements in VAS, WOMAC, LI, ambulation speed, and most items in the SF-36 after 10 days of treatment. In addition, patients in group I showed significant improvements in LI and VAS at follow-up. There were no FLIPUS-related adverse events during and after the interventions. In conclusion, FLIPUS is a safe and effective treatment modality for relieving pain and improving the functions and quality of life of patients with KOA.

Background Erectile dysfunction (ED) is characterized by a persistent inability to achieve and maintain sufficient penile erection for satisfactory sexual performance persisting for at least six months. Low-intensity pulsed ultrasound (LIPUS), a noninvasive therapy, has shown potential in improving ED by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation. This study aims to evaluate the clinical efficacy and histological changes in the corpus cavernosum of patients with ED treated with tadalafil combined with LIPUS through a randomized controlled trial. Methods This study will enroll 114 patients diagnosed with ED who will be randomly assigned to either the treatment group or the control group in a 1:1 ratio using simple random sampling. The treatment group will first receive 5 mg of tadalafil daily combined with twice-weekly LIPUS therapy for 4 weeks. Following a 4-week interval with daily 5 mg tadalafil alone (no LIPUS treatment), the same combined treatment regimen will be repeated. The control group will receive only 5 mg of tadalafil daily. The primary outcome will be assessed using the minimal clinically important difference (MCID) based on the International Index of Erectile Function-5 (IIEF-5) at each follow-up visit. Additional assessments will include the Erection Hardness Score (EHS), penile blood flow parameters, and elasticity values for a comprehensive evaluation. Discussion The study aims to evaluate the efficacy of tadalafil combined with LIPUS for treating ED and to improve the evaluation of treatment response in erectile dysfunction by integrating blood flow parameters and two-dimensional shear wave elastography. Trial registration Trial registration: ClinicalTrials.gov, NCT06543628. Registered 5th August 2024, https://clinicaltrials.gov/study/NCT06543628 .

Objective The primary objective of this clinical trial is to investigate the effect of low-intensity pulsed ultrasound (LIPUS) on patients suffering from comorbid erectile dysfunction (ED) and chronic prostatitis/chronic pelvic pain syndrome ( CP/CPPS). Methods The clinical trial was conducted in the andrology outpatient treatment room of the Department of Urology, Xiangya Hospital, Central South University from August to November 2022 A total of 60 patients who met the research criteria for comorbid ED combined with CP/CPPS were recruited and randomly assigned to three treatment groups. They were treated with LIPUS (Group A), drug therapy(Group B), and LIPUS combined with drug therapy (Group C), respectively. Each group comprised 20 patients. Statistical analysis was performed on the five-item version of International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the nine-item Patient Health Questionnaire (PHQ-9), the seven-item Generalized Anxiety Disorder Scale (GAD-7), and the incidence of adverse events to comprehensively evaluate the efficacy and safety of LIPUS. Results The positive response rate of ED and CP/CPPS treatment in Group A is 40%(8/20) and 45%(9/20), while those in Group B is 55%(11/20) and 60%(12/20), and those in Group C is 85%(17/20) and 85%(17/20). A notable increase in IIEF-5 scores was observed across the three groups post-treatment (10.45 ± 2.50 vs. 13.65 ± 3.03, P  = 0.008; 11.80 ± 3.21 vs. 16.40 ± 3.20, P  = 0.011; 12.90 ± 3.92 vs. 19.40 ± 2.35, P  = 0.042) with a concomitant significant decrease in NIH-CPSI scores (16.75 ± 4.53 vs. 14.65 ± 4.51, P  = 0.016; 16.35 ± 4.32 vs. 12.20 ± 4.74, P  = 0.007; 16.00 ± 4.40 vs. 8.15 ± 4.28, P  = 0.021). Notably, the most pronounced changes were seen in the group receiving LIPUS combined with tadalafil and doxazosin. Additionally, all groups exhibited marked improvements in anxiety and depression symptoms post-treatment. No adverse events were observed during treatment. Conclusion LIPUS can improve erectile function and CP/CPPS symptoms with good safety, and LIPUS combined with tadalafil and doxazosin is more effective during the treatment. However, its long-term efficacy remains to be seen. Trial Registration Chinese Clinical Trial Registry; approval number: ChiCTR2200063038 ( https://www.chictr.org.cn/ ) on August 29, 2022.

Background Non-unions, defined as fractures not healed after at least 6 months, are a multifactorial complication occurring in 2–10% of all fractures and in up to 30% of patients with certain risk factors. Treatment costs are markedly higher than those associated with normal fracture healing and patients often suffer from pain and loss of function. Surgical revision is the gold standard for treatment; however, the disadvantages are re-hospitalization, possible secondary diseases and side effects such as post-operative infections, complications of anesthesia and embolisms. Low-intensity pulsed ultrasound (LIPUS) is a low-risk procedure, with skin reactions being the only side effect experienced by a very small number of patients. Patients can use the treatment independently at home, eliminating the need for repeated hospital visits. This study aims to show that LIPUS treatment is not inferior to surgical intervention by a threshold of -25 percentage points in terms of fracture healing in non-unions of the upper or lower extremity. Methods PiNGUin will be a five-year national, prospective, controlled, randomized, open-label, multicenter study with a medical device. Patients are randomized into one of two groups: patients in the intervention group will receive daily 20-min LIPUS treatment for 200 days or undergo standard surgical intervention in the control group. Follow-up for both groups will be 12 months. The primary endpoint is fracture healing 12 months after treatment start, defined as bony consolidation of at least 3 out of 4 cortices and functional recovery. Secondary endpoints include time to fracture healing and to full weight bearing, incidence and intensity of pain, functional complaints/activities of daily living, health-related quality of life, complications, adverse events, re-operations or re-osteosyntheses and (re-) hospitalizations, hospital stays, duration and reasons for inability to work. With a one-sided significance level of 2.5%, a power of 90% and an assumed drop-out rate of 10% 184 patients will be required per treatment group. Discussion As LIPUS is a low-complication procedure with good results to date, this treatment is considered a potential alternative to surgery. If non-inferiority is proven, patients will have a choice of both invasive and non-invasive procedures in the future. Trial registration DRKS00034357 (German Clinical Trials Register, registered March 11th, 2025).

Background Growing demand for facial rejuvenation drives advancements in these therapies, including laser, radiofrequency, and focused ultrasound, alongside thermal stimulation adjuncts. These methods, known for stimulating collagen regeneration, skin tightening, and lifting, have gained popularity due to their minimal side effects, low trauma, and high safety, demonstrating favorable outcomes in clinical practice. Objective We sought to assess the efficacy of ultrasound skin tightening for brow lift within the scope of a procedure addressing facial sagging across the entire face. Our aim was to explore a noninvasive method capable of effectively enhancing mild to moderate brow ptosis by tightening and lifting the skin in the upper facial region. Methods This was a rater‐blinded, prospective cohort study. The upper facial region of the participants was treated with the new device, micro‐focused ultrasound (MFU), in model D3.0/D2.0/M3.0. Outcomes of brow lift were measured in comparison of pretreatment and posttreatment photographs and three‐dimensional (3D) vector analysis. Results A total of 42 participants (37 females) were enrolled, with 2 participants withdrawing from the trial, resulting in 40 subjects who completed 180‐day‐follow‐up and evaluation. 35 (87.5%) were deemed to have clinically significant brow elevation by two blinded assessors (experienced clinicians) at 180‐day posttreatment (p < 0.01). The mean change in brow height after 90‐day was 2.16 ± 0.63 mm at the frontal position (straight‐ahead gaze) (p < 0.01). The 3D vector analysis reveals varying magnitudes of vector displacement in the upward and outward directions of the skin on the frontal region above the eyebrows. Conclusion Focused ultrasound appears to be a safe and effective method for upper facial skin rejuvenation. A single focused ultrasound treatment on the forehead and temple areas resulted in an average brow elevation of 2.1 mm.