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The primary objective of this study is to assess the reduction in Postpartum Depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15 in study participants. The secondary objectives are to assess the reduction in PPD symptoms via the EPDS at Day 45 and Day 90 in study participants, reduction in PPD symptoms via the EPDS at Day 15,Day 45, and Day 90 in a subgroup of participants with moderate PPD at baseline, to assess breastfeeding status during treatment with zuranolone as reported at Day 45 and to characterize treatment usage across the 90-day period via self-reported survey questions.

Researchers are investigating a new surgical approach for upper limb amputations aimed at improving voluntary control and restoring sensation and proprioception in amputated limbs. This phase I pilot clinical trial will compare modified above elbow or below elbow amputation techniques to traditional methods in ten intervention patients versus ten control patients. The study intends to redefine amputation surgery to create a biological interface that enhances the use of next-generation prosthetic devices with advanced motor and sensory capabilities. The modified procedure involves creating agonist-antagonist muscle pairs by isolating specific muscle groups and nerves in the residual limb to promote dynamic muscle coupling and sensory feedback. This includes coapting muscles such as the flexor carpi radialis and extensor carpi radialis longus, among others, and redirecting sensory nerves to skin patches on the residual limb. The traditional procedure will be performed without these modifications. The trial will be conducted over three years across multiple centers, with six modified amputations at Brigham & Women's Hospital and four at Walter Reed National Military Medical Center. Participants will undergo assessments to measure motor unit innervation, motor unit excursion, and proprioception recovery over a 36-month period. Outcome measures include evaluating functional motor activation, muscle excursion, and sensory feedback to assess the advantages of the novel surgical technique. Participants will be closely monitored postoperatively, with follow-ups to evaluate sensorimotor recovery and adherence to rehabilitation protocols. The study aims to demonstrate improved motor control and sensory restoration compared to standard amputation methods.

Researchers are studying how the drug nusinersen (Spinraza42), used to treat spinal muscular atrophy (SMA), affects pregnant people with SMA and their babies. Since people with SMA are now living longer and reaching childbearing age, this study aims to collect important information about pregnancy outcomes and baby health when nusinersen is taken before or during pregnancy. The study compares three groups of participants based on when they received nusinersen relative to pregnancy and also compares data to people without SMA who have not used the drug. This observational study collects health information without changing medical care. Participants are identified through three SMA research networks in the US, UK, and parts of Europe. Data collection begins when participants join and continues throughout pregnancy with contacts every trimester, around 6-7 months of pregnancy, and about 4 weeks after delivery. Babies are followed up through their doctors at ages 1, 2, 6, 12, 18, and 24 months. Each participant remains in the study until 12 weeks after delivery, and babies are monitored for up to 2 years. The entire study is planned to last at least 10 years from the first participant enrollment. Participants are monitored for pregnancy complications, birth outcomes, and any adverse effects in their infants related to nusinersen exposure. Researchers track pregnancy losses, live births, baby growth and development, and maternal and infant deaths. Information is collected from both participants and their doctors at multiple points before, during, and after pregnancy. The study measures these outcomes over up to 10 years to better understand nusinersen's effects on pregnancy and infant health in people with SMA.

Researchers are evaluating how well participants and physicians understand the use and potential risks of GATTEX for treating Short Bowel Syndrome (SBS). This study involves a Knowledge Assessment Survey conducted every two years as part of the GATTEX Risk Evaluation and Mitigation Strategy (REMS) required by the U.S. FDA to ensure safe use of medicines with serious risks. The survey aims to assess understanding of recommended checkups, tests, and monitoring during GATTEX treatment. This is a non-interventional study where no study medicines are provided. Participants and physicians can complete the survey using their preferred method: internet, telephone, or paper. Both patient and prescriber knowledge are measured through this survey, with no treatments or procedures administered as part of the study. Participants who have taken GATTEX recently and health care providers who have prescribed GATTEX can join the survey. The study collects responses about knowledge of safety and use information. Researchers focus on the number of participants and prescribers who provide correct answers to survey questions. Safety and usage understanding is monitored, with no active treatment or follow-up required beyond survey participation.

Researchers are exploring a new surgical method to revise lower extremity residual limbs in patients who have already undergone above knee (AK) or below knee (BK) amputations. This approach aims to add biological actuators called agonist-antagonist myoneural interfaces (AMIs) to restore voluntary motor control, bring back proprioception (the sense of limb position), reduce or eliminate phantom limb pain, and regenerate lost muscle mass. The study also seeks to develop a modified postoperative rehabilitation plan tailored to this innovative technique. Participants will undergo a surgical procedure to reconstruct their residual limbs with AMIs. This revision surgery is designed to improve musculotendinous proprioceptive function and enhance the connection between the nervous system and muscles. The study will standardize the operative technique for both AK and BK amputation revisions and evaluate the effectiveness of these biological constructs in providing better motor control, sensory feedback, and reducing phantom limb symptoms. Throughout the study, participants will be monitored for changes in limb shape and muscle volume, motor activation and voluntary control of the AMI muscles, sensory perception, proprioception, general health, and any complications. These outcomes will be assessed over a period of one to three years to understand reinnervation timing, longevity of the constructs, and overall functional improvements compared to standard amputation approaches.

Researchers are evaluating the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in people with chronic spinal cord injury lasting more than one year. This pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study focuses on individuals aged 18 to 75 years with clinical signs of orthostatic hypotension and symptomatic hypotension. The main outcomes include changes in blood pressure symptoms reported by participants and blood pressure measurements taken three months after the implant. Participants first undergo a baseline screening and then have the ARC-IM System surgically implanted. They are randomized in a 2:1 ratio to receive either active electrical spinal cord stimulation (Group 1) or a control intervention mimicking the therapy without the active component (Group 2) for the first three months. Therapy activation sessions occur within 21 days of implantation, followed by independent use of the system at home. After three months, all participants move to an open-label phase where they receive the active therapy, with ongoing programming and therapy sessions. Throughout the study, participants are monitored through questionnaires assessing symptoms, seated blood pressure tests, and safety evaluations for adverse device effects up to six months after implantation. Researchers track therapy adherence and conduct programming sessions after the initial three months. The total study involvement includes screening, a three-month randomized treatment phase, and an open-label period with continued follow-up to assess long-term effects and safety.

Researchers are evaluating two different non-drug, virtual treatment options designed to improve the lives of adults with migraine. The study focuses on patients who have had migraine for at least one year with headaches occurring 4 to 20 days per month. Both treatment programs include 8 weekly group sessions conducted online, supported by an online platform offering extra content and learning materials. Participants are allowed to continue all their current medications during the study. The study involves two groups receiving behavioral interventions called Brain Education and WELLness with Migraine Group A and Group B. Each group participates in 8 weekly virtual sessions led by an instructor, plus access to an online platform for additional learning. There are no in-person visits required, and all activities are completed remotely. Pregnant women up to 16 weeks gestation at enrollment are eligible to participate. Participants will complete initial online screening and attend a scheduled phone or video call for baseline assessments and training on the online platform. They will keep a daily online headache diary and complete multiple online surveys throughout the study. The main outcome measured is the change in migraine-related disability after 8 weeks, assessed by the monthly Migraine Disability Assessment (mMIDAS). All assessments and monitoring are done virtually, allowing participants to remain at home during the study.

Researchers are investigating the effects of non-invasive 40Hz gamma frequency sensory stimulation on brain activity in cognitively normal, healthy adults. This Phase 2 pilot study aims to explore whether sensory stimulation using light, sound, and tactile devices can alter brain oscillations linked to attention, memory, and recall, which are often disrupted early in Alzheimer's disease. The study also evaluates the safety of these devices and their impact on brain connectivity, neuropsychological performance, blood biomarkers, and the microbiome. Participants will experience GENUS, a device delivering synchronized light and sound stimulation at 40Hz using LEDs and speakers, positioned at eye level while seated or held in the hands. Another device, Tactile GENUS, provides vibration-based stimulation through a wrist-worn or hand-held tool. These devices aim to entrain gamma frequency brain activity during a single visit. During a one-day visit at MIT, participants undergo various assessments including Electroencephalogram (EEG), Magnetoencephalography (MEG), magnetic resonance imaging (MRI), neuropsychological tests, and blood sampling in some cases. Researchers monitor brain activity changes, safety, and biological effects over one year, focusing on the effects of the GENUS stimulation on brain oscillations and cognitive function.

Alzheimer's disease is marked by significant memory loss, toxic protein buildup (amyloid and tau) in the brain, and altered gamma frequency brain waves. Researchers found that boosting gamma waves at 40Hz in Alzheimer's mouse models reduced these toxic proteins and improved memory. To explore this effect in humans, the study evaluates a light and sound device designed to deliver 40Hz brain stimulation safely at home for people with mild Alzheimer's disease. The study includes 60 participants, mostly aged 65 and older, with a small group of early-onset cases aged 50-65. The goal is to assess if this gamma stimulation can change brain activity, molecular markers, and cognitive function over six months. Participants are randomly assigned to use the GENUS device daily for 60 minutes at home for six months, either with active 40Hz light and sound stimulation or with sham settings without 40Hz stimulation. They will also wear a device like a Fitbit to monitor sleep patterns. The study involves three in-person visits at baseline, three months, and six months at MIT, where blood, fecal samples, EEG, MRI scans, cognitive tests, and questionnaires are collected. After six months, participants may continue in an optional extension phase for at least one year, during which all receive active 40Hz treatment and attend yearly visits. Throughout the study, researchers will measure changes in gamma brain waves, brain connectivity via MRI, molecular biomarkers from blood, and cognitive abilities. Safety is monitored by questionnaires on adverse effects immediately after stimulation and weekly phone calls. Sleep and activity patterns are tracked continuously with wearable devices. This comprehensive approach aims to provide important insights into using non-invasive 40Hz sensory stimulation as a potential therapy for mild to moderate Alzheimer's disease over extended periods.

Researchers are investigating how combining brief sessions of low oxygen breathing, transcutaneous spinal cord stimulation, and walking training may improve walking ability in people with chronic spinal cord injury. This study focuses on whether these combined therapies can enhance recovery of walking and strength, building on prior animal studies that showed mild low oxygen exposure improves breathing and spinal cord stimulation enhances function. The aim is to see if using low oxygen before spinal cord stimulation during walking training can lead to better functional independence and quality of life. Participants will undergo 8 sessions over two weeks of either low oxygen breathing or room air using air generators and facemasks. Each session includes 15 episodes alternating 1.5 minutes of low oxygen and 1 minute of normal air or continuous normal air for the sham group. They will also receive 45 minutes of walking training with either active or sham transcutaneous spinal cord stimulation. The stimulation is applied at 80% of the involuntary motor threshold during walking training, with the sham stimulation briefly increased then stopped. Throughout the approximately 12-week study, participants are assessed by measuring changes and rate of change in walking recovery using the 10 meter walk test. Researchers will evaluate walking function improvements and monitor safety. The study involves medical clearance, gait training sessions, and repeated evaluations to track walking ability and strength recovery over time.