Facial Paralysis

Researchers are evaluating outcomes of facial reanimation surgeries in patients with extensive, permanent, unilateral mid-facial paralysis from various causes. The study aims to compare facial disability and patient perceptions of facial appearance, well-being, and satisfaction among four groups undergoing different types of free gracilis muscle transfer surgeries. The investigation also compares surgeons' assessments with objective 3D analyses to determine the usefulness of 3D measures as outcome tools. This prospective observational study includes patients aged 18 to 75 scheduled for facial muscle reconstruction with one of four nerve innervation methods: trigeminal nerve graft, cross-face nerve graft, dual innervation, or midfacial modification involving nerve coaptation and selective neurolysis. Participants will be recruited from a single treatment center and followed at three visits: before surgery, and at 5 and 18 months after surgery to track changes in facial movement and patient well-being. At each visit, patients complete psychosocial questionnaires assessing the impact of paralysis and recovery, undergo 3D dynamic facial movement recordings, static 3D facial photography, and video recordings of facial animations. Data collected include facial impairment and disfigurement measures, patient-centered quality of life questionnaires, and comparisons of clinical scoring with 3D objective assessments. The total study duration for each participant is 18 months, focusing on long-term surgical outcomes.

Researchers are studying a new feedback-enabled magnetic device designed to temporarily manage blepharoptosis, a condition where the upper eyelid droops. The study aims to evaluate how well the device improves eyelid height, symmetry of blinks, and reduces symptoms like visual field obstruction, blurred vision, and discomfort on the eyelid and surrounding skin. The safety and effectiveness of this device will be compared with outcomes from patients who undergo surgery for the same condition. The device includes near-infrared sensors, a magnetic actuator, an iron sheet for attaching to the affected eyelid, and a biosignal module. During the study, participants will use the device for sessions lasting about 120 minutes each. Researchers will measure the distance the eyelid lifts and assess muscle activity related to eyelid movement. Both subjective sensations and any side effects will be monitored to evaluate the device’s performance. Participants will have their eyelid measurements taken before and after using the device, along with assessments of visual field changes and muscle activity. These evaluations occur shortly after device use and include checking for any skin irritation or discomfort. The study also includes follow-up examinations comparing device use with surgical treatment outcomes at one and six months. The total participation time for each device use session is about two hours, with longer-term follow-up for surgical cases.

Researchers are studying a surgically implanted functional electrical stimulation (FES) system designed to improve stability of the trunk and hips in people with spinal cord injuries, paralysis, tetraplegia, or paraplegia. This system uses small electric currents to make muscles contract, aiming to help users sit more steadily, breathe better, reach farther, push a wheelchair, or roll in bed. The study is conducted by the VA Office of Research and Development and focuses on how this neuroprosthesis affects posture and mobility. The study involves one surgical procedure to implant electrodes into the trunk and hip muscles. These electrodes connect to an 8-channel stimulator implanted in the abdomen. After surgery, participants spend two to six weeks at home with limited activity to allow healing. Following this, they undergo exercise and training to begin using the neuroprosthesis functionally. Participants will be assessed in the lab for strength, balance, and functional abilities both with and without the system, while the implanted device’s technical performance is also monitored. Participants will be involved for up to 36 months, during which researchers will measure the effects of trunk stimulation on posture control, breathing, pressure distribution while seated, reach ability, stability, and personal mobility. They will also work on designing a simple position controller. The study includes post-operative training and follow-up visits to track progress, device function, and safety over time.

Researchers are evaluating the efficacy and safety of a new drug called STN1013800 ophthalmic solution for treating acquired blepharoptosis in Chinese patients. This condition involves drooping of the upper eyelid, and currently, there are no approved medicines for this in China. This is a Phase III randomized, double-masked, placebo-controlled study designed to compare STN1013800 with a placebo solution. Participants will receive either 0.1% STN1013800 ophthalmic solution or a placebo once daily for 42 days, based on prior clinical trial results. The study includes a screening period lasting 3 to 7 days to confirm eligibility. The interventions involve applying the assigned eye drops daily, with the study treatment and placebo groups monitored in parallel. During the study, participants will undergo multiple assessments including margin reflex distance-1 (MRD-1) measurements and Leicester Peripheral Field Test (LPFT) scores at several time points (Day 1 Hour 6, Day 14 Hour 2, and Day 42). Researchers will track changes from baseline in eyelid position and visual function to evaluate treatment effects. Safety and adherence will also be monitored throughout the 42-day treatment period.

Researchers are evaluating the safety and effectiveness of NT 201, a type of botulinum toxin A, compared with a placebo in adults who have moderate to severe platysma prominence, which refers to noticeable bands in the neck area. This Phase 3 study aims to understand how well NT 201 works and how safe it is for these participants. The study is sponsored by Merz Aesthetics GmbH and will be conducted in Europe. Participants will be randomly assigned to receive either a single injection of NT 201 or a matching placebo injection in the main study period (MP) on Day 1. After this period, those who received NT 201 can enter an open-label extension period (OLEX) where they will receive another injection of NT 201 on Day 1 of that phase. The study involves a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during the main period. During the study, participants will be assessed using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) to measure improvement in platysma prominence at various time points, including Week 2 and up to Week 17 in the main period. Both investigator and participant assessments will be used to evaluate the degree of improvement. Satisfaction questionnaires and global aesthetic improvement scales will also be used to measure participant satisfaction and aesthetic changes. Safety and efficacy will be closely monitored throughout the study, which lasts through the main and extension periods.

Researchers are evaluating skin changes in adult women with moderate-to-severe cheek wrinkles using non-invasive imaging methods. The goal is to study the effects of treatments aimed at improving volume deficiency, skin laxity, and photo-aged skin in the mid-face area. This is an open-label, single-center study sponsored by Galderma R&D involving women aged 45 to 65 years. Participants will receive three treatments of Sculptra injections into the cheeks, spaced four weeks apart. Each treatment involves subdermal injections using a 25 G needle, with up to 18 mL total per session. The injections target the subcutaneous and supraperiosteal regions evenly across both cheeks. The study focuses on monitoring structural skin changes following these biostimulator treatments. During the study, participants will undergo standardized VISIA imaging and optical biopsy imaging at multiple time points: 4, 8, 12, 16, and 20 weeks after baseline. Researchers will assess changes in the midface structure compared to before treatment. Participants must adhere to a skincare regimen provided by the study and allow photographs at each visit. Safety and response will be monitored throughout the study period, which runs until September 2026.

This research focuses on patients experiencing stiff knee gait (SKG), a condition caused by spastic muscle complications in the leg that can result from stroke, brain injury, spinal cord damage, or multiple sclerosis. SKG affects the mobility of the knee joint, leading to stiffness that hampers walking ability. The study aims to observe and compare balance and risk of falls before and after treatment with botulinum toxin injections in the rectus femoris muscle, which is a current standard treatment to reduce muscle spasticity in these patients. Participants will receive botulinum toxin injections targeted to the rectus femoris muscle. The study is observational and will evaluate the effects of these injections on balance and walking ability without altering standard care. Functional clinical tests such as the Time Up and Go test, Berg Balance Scale, Stair Climb and Descent Time test, and a questionnaire about the number of falls will be used to assess participants before and four weeks after the injections. Throughout the study, participants will undergo these clinical tests to measure static and dynamic balance and walking function. Researchers will specifically focus on the Time Up and Go test as the primary outcome four weeks after treatment. Secondary outcomes include balance scale scores, stair climbing times, and fall frequency. The study will also monitor safety and compliance. The total study duration for each participant is at least four weeks from the inclusion visit to the post-injection evaluation.

This research aims to compare two surgical techniques, anterior and posterior white line advancement, for correcting primary aponeurotic ptosis in adults. The study seeks to determine if the anterior approach improves eyelid position, measured by Marginal Reflex Distance 1 (MRD1), better at 6 months than the posterior approach. It also evaluates differences in eyelid symmetry, contour, vision, and patient satisfaction between the two methods. Participants will be randomly assigned to one of two groups: one receiving the anterior approach involving a skin crease incision to access and advance the levator aponeurosis, and the other receiving the posterior approach, which uses a conjunctival incision without a skin cut. Both surgeries involve advancing the white line to the anterior tarsus using sutures. The study includes follow-up visits at 7 days, 2 months, and 6 months after surgery. During these visits, researchers will measure eyelid position and symmetry, evaluate eyelid contour using both software and masked evaluators, and test vision and tear film stability. Patients will also complete surveys on dry eye symptoms, scar quality, satisfaction, and psychosocial function. Surgical time and complications will be monitored. All images and data will be securely stored, and outcome assessors will be blinded to the group assignments for certain evaluations.

Researchers are evaluating the accuracy and effectiveness of patient-specific plates (PSPs) designed through virtual surgical planning (VSP) for correcting a tilted upper jaw (maxillary cant) in people with facial asymmetry. This prospective clinical trial focuses on how well the actual surgery matches the planned virtual surgery and how satisfied participants are with their appearance after the procedure. The study addresses challenges in traditional surgery by using 3D planning and custom devices tailored to each patient's anatomy. Participants will undergo detailed CT scans to create 3D models of their craniofacial structure. Custom titanium plates and cutting guides are designed and manufactured using 3D printing and milling techniques. Surgery involves precise bone cuts guided by these tools to reposition the upper jaw as planned. The study includes a follow-up period of six months to monitor healing and assess outcomes. During the trial, participants will have multiple CT scans to compare the planned surgical corrections with the actual results. Researchers will evaluate the accuracy of bone repositioning by superimposing images taken before and after surgery at intervals of 1 week, 1 month, 3 months, and 6 months. They will also assess aesthetic results and participant satisfaction. Postoperative care and follow-up visits are standardized to ensure consistent monitoring throughout the study period.

Researchers are evaluating the use of EEG-based Brain-Computer Interface (BCI) technology to detect awareness and enable communication in people with prolonged disorders of consciousness (DoC), such as unresponsive wakefulness syndrome (UWS), minimally conscious state (MCS), and locked-in syndrome (LIS). The study aims to improve diagnosis accuracy where traditional methods relying on motor responses may fail, and to explore if BCI can provide movement-independent communication. The trial also investigates whether training with BCI can enhance brain response consistency and communication ability. Participants undergo three phases: Phase I assesses if patients can imagine movements and produce detectable brain activity using EEG. Phase II involves training with motor imagery BCI and real-time auditory feedback to help participants modulate brain signals. Phase III tests participants' ability to answer yes-no questions using imagined movement patterns. The study uses specific imagined movement combinations to represent 'yes' or 'no' responses, tailored individually and applied throughout sessions lasting about 1.5 hours each. During the study, participants complete up to 10 sessions including assessments, training, and communication tasks. Researchers monitor changes in BCI performance accuracy, ability to communicate consistently, and clinical scale scores related to consciousness and recovery. The study evaluates how feedback types and timing affect performance and collects data to support clinical diagnosis and potential therapeutic benefits. Participation involves EEG recordings, neurofeedback, and answering structured questions over several weeks.