West Orange

This research aims to collect real-world data on the Cerene Cryotherapy Device, which is used for endometrial cryoablation in premenopausal women experiencing heavy menstrual bleeding due to benign causes and who have completed childbearing. The study focuses on bridging the gap between clinical trial results and outcomes seen in everyday use. It involves women aged 25 years and older who undergo Cerene treatment and tracks their experiences over time. Participants will receive treatment using the Cerene device as it is used in regular clinical practice. The study will observe up to 300 women who have had the Cerene procedure. Data collection includes surveys completed by both patients and physicians, covering patient demographics, quality of life assessments, procedural details, and clinical outcomes after the treatment. Participants will be involved in the study for about 13 months, starting from enrollment through 12 months after treatment. During this time, they will complete surveys at specific intervals to report on their quality of life and any clinical changes. Researchers will monitor outcomes such as the rate of additional procedures needed within 12 months, the location where care is provided, and patients' quality of life throughout the study period.

Researchers are evaluating felzartamab in adults who have received a kidney transplant and later developed microvascular inflammation (MVI), a type of injury to small blood vessels in the transplanted kidney. This inflammation may indicate rejection by the body and can cause serious kidney problems over time. The study focuses especially on a form called isolated MVI, which occurs without antibodies and currently has no approved treatments. The main goal is to understand how felzartamab affects inflammation in the transplanted kidney compared to a placebo. The study is a Phase 2, double-blind, placebo-controlled trial with two parts. In Part A, participants are randomly assigned to receive either felzartamab or placebo through intravenous (IV) infusion for 24 weeks without knowing which treatment they receive. In Part B, lasting 28 weeks, all participants receive felzartamab openly. Kidney biopsies are performed at the start, Week 24, and Week 52 to assess changes in inflammation. The trial includes monitoring kidney function and immune activity alongside safety assessments. Participants will be involved for about one year, undergoing kidney biopsies, lab tests, and regular health evaluations. Researchers will collect data on biopsy-proven histologic resolution of inflammation at Week 24 as the primary outcome. Safety is monitored through adverse event reporting and additional clinical measures. The study also includes assessments of felzartamab's pharmacokinetics and immunogenicity during both parts of the trial.

Researchers are studying the effects of felzartamab, a laboratory-made antibody, in adults who have received kidney transplants and are experiencing antibody-mediated rejection (AMR). AMR happens when the immune system mistakenly attacks the new kidney, causing damage that can lead to organ failure. This phase 3 trial aims to compare felzartamab to a placebo to see how well it helps treat AMR in kidney transplant patients. The study focuses on how many participants have kidney tissue that looks normal or nearly normal after 24 weeks of treatment. Participants will be randomly assigned to receive up to 9 doses of either felzartamab or a placebo through an intravenous infusion based on their body weight during the first part of the study, which lasts up to 24 weeks and is double-blind. In the second part, lasting up to 28 weeks, all participants will receive felzartamab in an open-label phase where everyone knows the treatment being given. In total, participants will have up to 21 study visits over about one year. During the study, participants will undergo kidney biopsies, blood and urine tests, electrocardiograms, and other assessments to monitor kidney function, immune response, and safety. Researchers will measure how long the transplanted kidney works, changes in antibody levels, signs of rejection, and side effects. The study also monitors how felzartamab is processed by the body and whether participants develop antibodies against the drug. Screening before enrollment can take up to 42 days.

Researchers are evaluating two behavioral treatments for acquired dyslexia following a left hemisphere stroke. This early phase 1, low-risk, multicenter trial uses a computational cognitive model of reading to simulate acquired dyslexia and predict the most advantageous treatment. The goal is to compare the effects of phonomotor treatment (PMT) and semantic feature analysis (SFA) to see which is more beneficial for improving reading skills in stroke survivors. The study involves two full rounds of treatment for all participants. Each round consists of either PMT or SFA for a total of 60 hours, delivered over 5 days a week at 2 hours per day. PMT focuses on training phonemes in spoken and written language using multi-sensory methods without showing pictures or definitions. SFA encourages retrieval of words by discussing semantic features of written nouns, using pictures as cues and exploring six categories of word features until the noun is read correctly three times consecutively. Participants will be assessed using the Woodcock Reading Mastery Test - III at baseline, after the first 60 hours of therapy, and after the final 60 hours of therapy. The study measures improvements in reading words and pseudowords to evaluate treatment effectiveness. Participants must undergo brain imaging and meet specific language and sensory criteria. The study lasts through both treatment rounds with regular monitoring of reading progress and response to therapy.

Researchers are evaluating how cardiovascular function changes during the first year after a spinal cord injury and how treatments like transcutaneous spinal stimulation affect blood pressure. The study focuses on individuals with recent spinal cord injuries at or above the T6 level, experiencing low blood pressure and orthostatic hypotension, aiming to determine the best timing for spinal stimulation and to understand autonomic activation patterns over a year. Participants will receive spinal cord transcutaneous stimulation using a 5-channel electrical stimulator called Neostim-5. This stimulation will be applied during seated mapping sessions to identify optimal stimulation sites and parameters that maintain systolic blood pressure between 110-120 mmHg. Additionally, stimulation will be used during 70-degree tilt tests to assess orthostatic responses. The study includes an inpatient phase of 5-11 sessions shortly after injury and an outpatient phase with 15-18 sessions over the following months, involving monthly mapping and comprehensive autonomic testing at 6, 9, and 12 months post-injury. Participants will undergo various assessments including autonomic dysfunction questionnaires, 24-hour blood pressure monitoring, cold pressor tests, and repeated tilt tests with and without stimulation. Blood pressure and electromyography will be continuously monitored throughout. The study will track systolic blood pressure changes over time in seated and tilt positions, observe orthostatic hypotension symptoms, and evaluate the development of autonomic dysfunction. The total study duration for each participant is approximately one year with 20-29 sessions in total.

Researchers are investigating new learning and memory impairment (NLMI) in people with moderate to severe traumatic brain injury (TBI), a condition that significantly impacts daily life. This study evaluates the combined effects of a cognitive rehabilitation method called the Kessler Foundation modified Story Memory Technique (KF-mSMT) and aerobic exercise training (AET) compared to KF-mSMT with stretching exercises. The trial aims to improve learning, memory, brain function, and daily life outcomes in individuals with TBI-related NLMI. Participants will be randomly assigned to one of two groups: one receiving KF-mSMT plus aerobic exercise training, and the other receiving KF-mSMT plus stretching exercise training as an active control. Both interventions occur three days per week for 12 weeks, with session durations starting at 15 minutes and increasing up to two hours by the end of the program. All sessions are supervised by study personnel, and participants remain unaware of the study's intent. During the 12-week study, participants will undergo various assessments including cognitive tests like the California Verbal Learning Test-3 to measure learning and memory changes. Brain imaging using hippocampal MRI will be performed to observe neural effects. Daily life outcomes will also be evaluated to assess real-world benefits. The study monitors safety and aims to provide meaningful improvements to all participants, with total participation lasting about 12 weeks.

Researchers are evaluating a new combined approach to treat reading disorders after stroke by using exercise training alongside targeted reading therapy. The study focuses on individuals with chronic left-hemisphere stroke who have reading deficits due to aphasia, a condition that limits communication and independence. This randomized controlled trial aims to improve reading and language skills by increasing brain blood flow and strengthening damaged neural networks involved in reading. Participants will receive 40 sessions of a targeted reading therapy called Phono-Motor Therapy (PMT), which involves exercises to improve awareness of sounds and letter patterns using real and nonword letter strings. Along with PMT, participants will either engage in 20 minutes of moderate aerobic exercise on a stationary bike or perform light stretching exercises. The study includes three MRI scans to monitor brain changes before treatment, after the first exercise session, and after completing all treatment sessions. During the study, participants will complete various behavioral tests and brain imaging assessments to measure improvements in reading aloud, reading comprehension, brain blood flow, and brain connectivity. These evaluations take place before treatment and within two weeks after finishing the treatment, around 10 weeks from the start. The study also tracks participants' brain responses during tasks and monitors safety and progress throughout the trial.

This research aims to evaluate the safety, feasibility, and preliminary effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) to improve upper limb function in individuals with acute to subacute cervical spinal cord injury (SCI) during inpatient rehabilitation. The study compares this combined approach to a sham stimulation with ABT and ABT alone to explore whether it leads to better recovery of hand, arm, and trunk abilities. Researchers also seek to understand the neurophysiological changes linked to these interventions by studying cortical and spinal excitability. Participants will receive one of three interventions over 10 sessions within two weeks: scTS plus ABT, sham scTS plus ABT, or ABT only. Each session lasts 30 minutes and is part of a daily three-hour therapy routine. The active scTS involves customized stimulation applied through electrodes placed on the skin over the cervical and thoracic spine, aiming for sub-threshold muscle activation without visible contractions. The sham group experiences a brief stimulation sensation without ongoing stimulation. The ABT focuses on gross and fine motor skills, including grasping and pinching tasks tailored to individual ability. Throughout the study, participants undergo assessments before, during, immediately after the intervention, and at 1-, 2-, and 3-month follow-ups. Researchers measure changes in pain, skin integrity, upper extremity motor function, handgrip strength, and overall functional ability. Safety is monitored by tracking adverse events related to scTS, ABT, and SCI symptoms. The study completion rate is also recorded to evaluate feasibility. The total participation duration spans the intervention period plus three months of follow-up evaluations.

Researchers are evaluating the Q Therapeutic System (BQ 3.0), a wearable medical device that delivers low-intensity, low-frequency electromagnetic fields to stimulate brain networks. The goal is to reduce disability and support recovery after ischemic stroke in adults aged 22 to 80 years. This multicenter study involves about 20 to 30 centers and compares active treatment to a sham device in a randomized, controlled design. The study has three stages: Stage 1 runs from 4 to 21 days after stroke onset to day 90, where participants receive either active or sham treatment five times per week, completing at least 45 sessions. Each session lasts about 60 minutes, with 40 minutes of stimulation combined with a home-based exercise program. In Stage 2, from day 90 to day 180, all participants who adhered to Stage 1 can continue active treatment up to five times weekly. Stage 3, from day 180 to day 270, involves no treatments but continued follow-up. Participants and caregivers receive training on device use and exercises, with support provided remotely or in person. Researchers assess outcomes at days 45, 90, 180, and 270 after stroke, focusing on changes in neurological disability using the Modified Rankin Scale. Safety is monitored throughout, and participation complements usual care without replacing it.

Researchers are evaluating the effects of combining transcutaneous lumbosacral stimulation (TLS) with exoskeleton-assisted walking (EAW) compared to EAW alone on walking recovery in people with incomplete spinal cord injury (iSCI). This study involves 24 participants with sensory and motor iSCI who are non-walkers and wheelchair-reliant, with injuries more than 6 years old and neurological levels between C5 and T10. The goal is to assess improvements in walking ability and related functions using objective measures over a 28-week training period. Participants will be randomly assigned to one of two groups: one group will receive 60 minutes of exoskeleton-assisted walking combined with TLS followed by 15 minutes of overground training without the exoskeleton, while the other group will receive 60 minutes of exoskeleton-assisted walking alone followed by the same 15 minutes of overground training. Training occurs three times a week for 28 weeks, totaling 80 sessions. The TLS is applied using wireless surface electrodes over the lower spine during walking in the EAW+TLS group, providing stimulation without causing muscle activation. Both groups follow similar training protocols involving standing, walking on various surfaces, ramps, and doorways, with sessions adjusted for participant fatigue and monitored for safety. During the study, participants undergo repeated assessments including the 6-minute walk test and 10-meter walk test at baseline and after 20, 40, 60, and 80 training sessions. Blood pressure and participant tolerance are monitored closely during training. Researchers will also evaluate changes in walking patterns, muscle activation, and spinal cord connectivity using advanced imaging techniques. The total involvement spans the 28-week training period with detailed monitoring to understand recovery progress and safety.