West Orange

Researchers are collecting real-world data on the Cerene Cryotherapy Device, which was approved by the FDA in 2019 for treating heavy menstrual bleeding in premenopausal women who have completed childbearing. This observational study aims to compare outcomes from routine clinical use of the Cerene device with results from previous pivotal studies, helping to understand its effectiveness and safety in everyday practice. Participants in this registry will have received treatment with the Cerene device as part of their standard medical care. The study does not involve any additional active interventions beyond this treatment. Data collection includes patient and physician surveys covering demographics, quality of life, procedural details, and clinical outcomes following the Cerene treatment. Women will participate for about 13 months, starting from enrollment and continuing through a 12-month follow-up after treatment. During this time, surveys will be completed at multiple points to assess re-intervention rates, quality of life, site of service, physician feedback, and cost analysis. The study concludes after the last participant completes her one-year follow-up visit.

Researchers are studying felzartamab in adults who have received a kidney transplant and later developed microvascular inflammation MVI, a condition causing injury to small blood vessels in the transplanted kidney. Some cases of MVI occur without antibodies and are called isolated MVI, for which there are currently no approved treatments. This research aims to understand how felzartamab affects inflammation in the transplanted kidney and related health aspects. Participants are randomly assigned to receive either felzartamab or a placebo for 24 weeks without knowing which they receive. After this, all participants receive felzartamab openly for another 28 weeks. Treatments are given through intravenous IV infusions at the study site. Kidney biopsies are done at the start, week 24, and week 52 to observe changes in inflammation. Throughout the study, participants will have lab tests and health monitoring, including recording any health problems that may happen. Researchers will measure kidney inflammation, function, immune activity, and overall health over about one year. Safety is closely watched using biopsies, lab results, and adverse event reports to better understand felzartamabs effects.

Researchers are studying acquired dyslexia caused by stroke to see if a computer-based model can predict which type of reading therapy will work best for each person. This early phase 1 trial compares two different treatments using a neural network cognitive model to simulate dyslexia and its treatment. The goal is to find out if following the models treatment recommendation offers an advantage over the alternative therapy. Participants will receive two rounds of therapy, each consisting of 60 hours over about six weeks 5 days a week, 2 hours per day. The therapies tested are Phono-Motor Therapy PMT, which focuses on phonological training with letters and sounds, and Semantic Feature Analysis SFA, which uses word meanings and categories to support reading. One group will get the therapy that matches the models prediction for their reading impairment, while the other group will receive the non-matched therapy first and then switch to the other therapy. During the study, participants will have assessments at the start, after the first 60 hours, and after the final 60 hours of therapy. These include reading tests like the Woodcock Reading Mastery Test and wordpseudoword reading, as well as language and aphasia evaluations. Researchers will closely monitor progress throughout the therapy sessions to measure changes in reading ability and language skills. The entire study allows adults aged 18 to 85 with stroke-related acquired dyslexia to participate and lasts through both treatment rounds and follow-up assessments.

Researchers are investigating cardiovascular function changes during the first year after a spinal cord injury SCI, focusing on how blood pressure responds to spinal cord transcutaneous stimulation scTS. The study targets individuals with recent SCI who have low blood pressure and orthostatic hypotension, aiming to determine the best timing to start scTS and understand how cardiovascular activation evolves over time. The study includes both inpatient and outpatient phases, with detailed autonomic function testing to assess blood pressure and autonomic responses. Participants receive scTS using a 5-channel electrical stimulator starting shortly after injury, with sessions occurring regularly over one year. The inpatient phase involves 5-11 sessions including autonomic questionnaires, 24-hour blood pressure monitoring, cold pressor tests, and tilt tests with and without stimulation, along with 2-3 days of stimulation mapping. The outpatient phase includes 15-18 sessions with monthly mapping and autonomic assessments, plus comprehensive testing at 6, 9, and 12 months post-injury. A supplementary spin-off study compares two cooling methods ice-water immersion and ice-wrap in different body positions to find the most consistent blood pressure response. Participants undergo multiple assessments such as 70-degree tilt tests, cold pressor tests, autonomic dysfunction questionnaires, and 24-hour ambulatory blood pressure monitoring at regular intervals throughout the year. Blood pressure and electromyography are monitored continuously during stimulation to maintain target blood pressure levels. The study tracks blood pressure response to stimulation, orthostatic hypotension symptoms, and autonomic dysfunction development. The total study duration covers about 20-29 sessions from inpatient stay to outpatient follow-up extending up to one year post-injury.

This trial investigates new learning and memory impairment NLMI in people with moderate to severe traumatic brain injury TBI. The study evaluates whether combining aerobic exercise training AET with the Kessler Foundation modified Story Memory Technique KF-mSMT improves memory, brain function, and daily life outcomes better than KF-mSMT with stretching exercises. The goal is to find more effective ways to help individuals with TBI regain memory abilities and improve quality of life. Participants are randomly assigned to one of two groups one receiving KF-mSMT alongside supervised aerobic cycling, and the other receiving KF-mSMT with supervised stretching and toning exercises. Both interventions occur three days per week for 12 weeks, with the cognitive rehabilitation starting after the first 4 weeks of exercise. Each session starts at 15 minutes and gradually increases to 2 hours by the end of the program. During the study, participants will be regularly assessed using memory tests, brain MRI scans focusing on the hippocampus, and everyday memory simulations to measure progress. The primary outcome is change in verbal learning test performance over 12 weeks. Safety and adherence will be monitored while participants complete questionnaires and cognitive evaluations. The study lasts 12 weeks, with ongoing evaluation of how these combined treatments affect memory and brain health in TBI patients.

Researchers are evaluating a new combined approach to treat reading disorders after stroke, focusing on improving language through exercise and targeted therapy. The study involves adults with chronic aphasia caused by left-hemisphere stroke, aiming to enhance cerebral blood flow and rebuild damaged brain networks related to reading. This randomized controlled trial intends to advance understanding of stroke recovery and improve functional outcomes for individuals with post-stroke reading deficits. Participants will receive 40 sessions, each lasting 2 hours daily, four to five times a week. One group will perform 20 minutes of moderate aerobic cycling exercise followed by 90 minutes of Phono-Motor Therapy PMT, which targets sound units and syllables to improve reading skills. The comparison group will do light stretching exercises for 20 minutes before the same PMT session. Both groups begin with warm-up and cool-down periods and complete logs on their experiences. Before, during, and after the treatment course, participants undergo behavioral testing and three MRI scans to measure brain activity and blood flow changes. Assessments include reading aloud, comprehension, and language batteries, conducted at baseline and within two weeks after treatment completion, approximately 10 weeks from the study start. The study also monitors participants effort and safety throughout the intervention to evaluate the combined treatments effectiveness and neurological impact.

Researchers are studying the safety and practicality of spinal cord transcutaneous stimulation scTS combined with activity-based training ABT for people with acute to subacute cervical spinal cord injury SCI during inpatient rehabilitation. The trial aims to see if this combined approach is safe, feasible, and whether it improves hand, arm, and trunk function better than ABT alone or a sham stimulation control. The study also explores changes in brain and spinal cord activity to understand how these treatments may work. Participants are randomly assigned to one of three groups scTS with ABT, sham scTS with ABT, or ABT only. Treatments are given over 10 sessions across 2 weeks, each lasting 30 minutes as part of daily therapy. The active scTS involves skin electrodes delivering mild stimulation to the cervical and thoracic spine, adjusted for comfort without visible muscle contractions. The sham group receives a brief, low-level stimulation to mimic sensations without therapeutic effects, while the ABT group focuses on upper limb motor tasks like grasping and pinching. Participants undergo assessments before, during, and after the intervention, plus follow-ups at 1, 2, and 3 months. Safety is monitored by tracking pain, skin condition, adverse events, and vital signs. Functional outcomes include hand strength and upper limb motor skills measured by specific tests. Researchers also evaluate study completion rates and will compare changes in cortical and spinal excitability to assess the interventions impact. The total study duration for each participant is about 3 months from start to final follow-up.

Researchers are evaluating the Q Therapeutic System BQ 3.0, a wearable medical device that delivers very low-intensity, frequency-tuned electromagnetic fields to stimulate brain networks. This study aims to assess whether this treatment can reduce disability and promote recovery in adults who have experienced an ischemic stroke. The study is conducted across multiple centers and compares active treatment with a sham inactive device in a randomized, double-blind design. The study begins 4 to 21 days after the stroke event. In the first stage up to day 90 post-stroke, participants receive either active or sham treatments five times a week, totaling at least 45 sessions. In the second stage day 90 to day 180, all participants who completed stage 1 can continue to receive active treatments up to five times weekly. In the third stage day 180 to day 270, no treatments are given, and participants are monitored until the final visit. Each session lasts about 60 minutes, including 40 minutes of device use combined with a home-based exercise program. Participants will be trained, with caregiver support as needed, to use the device and perform exercises at home. The study team provides periodic remote supervision and technical support. Assessments of recovery and function will occur at multiple points, including days 45, 90, 180, and 270 after the stroke. Researchers will monitor safety by recording any adverse events or device issues. Usual medical care continues alongside the study treatments throughout the participation period.

Researchers are evaluating the effect 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 a total of 24 participants with subacute to chronic sensory and motor iSCI, randomized into two groups. The goal is to assess how these interventions influence walking ability and recovery over time.

This research investigates the use of focused extracorporeal shockwave therapy f-ESWT as a treatment for subchondral bone marrow lesions BMLs in people with knee osteoarthritis OA. BMLs are closely linked to knee pain, structural damage, and disease progression in knee OA, often leading to long-term disability and increased risk of knee replacement surgery. The study aims to explore the efficacy and safety of f-ESWT compared to standard care such as analgesics and protected weight bearing in patients with persistent BMLs despite conservative treatment. Participants will receive four sessions of high-energy f-ESWT over four consecutive weeks, targeting the subchondral bone area with BMLs identified by MRI. The therapy involves focused shockwaves delivered by a device at energy levels between 0.28-0.60 mJmm. The study will monitor changes in pain and knee function, with MRI scans performed before treatment, and at 3 and 6 months post-treatment. This pilot, randomized-controlled study includes 30 subjects who have confirmed BMLs and knee pain lasting more than 2 months. During the study, participants will be assessed at baseline, 1, 2, 3, and 6 months after treatment using an 11-point numerical rating scale for knee pain and the Knee injury and Osteoarthritis Outcome Score KOOS to measure knee function and quality of life. MRI imaging will evaluate the area and condition of BMLs at specified intervals. Researchers will also monitor for any adverse events throughout the trial. The total participation duration spans at least 6 months with multiple follow-up assessments to evaluate treatment outcomes and safety.