Tethered Cord Syndrome

Researchers are evaluating which medication, dexamethasone or dexmedetomidine, works better and is safer when added to a local anesthetic called ropivacaine in a nerve block named the erector spinae plane block ESPB. This nerve block helps reduce pain after lumbar spine surgery. This phase 4, randomized, double-blind trial aims to improve pain management while reducing opioid use and their side effects after spine surgery. All participants will undergo general anesthesia for lumbar spine surgery and receive a bilateral ESPB using ultrasound guidance. The nerve block will include ropivacaine combined with either dexamethasone, dexmedetomidine, or a placebo saline. Participants are randomly assigned to one of these three groups, and neither patients nor pain assessors will know which medication was used. During the study, researchers will monitor opioid use during the first 24 and 48 hours after surgery as the main outcome. They will also assess pain intensity at multiple time points, time to first pain relief, any nerve injuries, side effects such as nausea or low blood pressure, and laboratory markers like blood glucose and inflammation ratios. Participants are expected to stay in the hospital for at least 48 hours for monitoring and assessments.

This research aims to establish the feasibility and detailed parameters of Magnetic Resonance Spectroscopy MRS for assessing spinal cord lesions in adults. The study focuses on mapping the total spine spectrum at short echo times to facilitate future comparisons for evaluating the malignant potential and grading of spinal cord lesions. Additionally, it will explore the reproducibility of the MRS protocol and investigate the effects of radiation on the spinal cord over different time frames in patients receiving craniospinal irradiation CSI. Participants include both healthy volunteers and patients with low volume leptomeningeal disease LMD undergoing standard CSI treatment. The study involves performing MRS scans on the spine to gather data on the spinal cord spectrum. This protocol will be applied to volunteers and patients to test its applicability and reproducibility. The study will collect data during and after radiation therapy to assess changes and support future trials focused on functional status and tumor grading. Participants will undergo MRS spine scans as the main study procedure. Researchers will monitor safety and any adverse events throughout the study period, which is expected to last up to one year. The study collects imaging data to evaluate spinal cord lesions and radiation effects while ensuring participant consent and ability to comply with procedures. This observational period will help establish MRS as a potential diagnostic tool for spinal cord assessment.

Researchers are evaluating whether surgical release of the filum terminale, a fibrous tissue at the end of the spinal cord, provides better symptom relief than medical management in patients with Occult Tethered Cord Syndrome OTCS. This phase II pilot randomized-controlled trial aims to assess the preliminary effectiveness and safety of surgery compared to medical treatment for this condition. Participants will be randomly assigned to either undergo surgical untethering of the filum terminale or receive only medical management. Symptom improvement and any adverse events will be monitored and recorded for one year after treatment begins. After at least one year, patients initially receiving medical management may switch to surgery if the principal investigator considers it beneficial. Throughout the study, participants will have their symptoms evaluated using the OCCULT Scale at the start and after one year. Additional assessments include urologic and fecal incontinence scores, medication changes, and intra-operative findings during surgery. Safety and symptom changes will be carefully tracked for one year to understand the treatment effects and risks involved.

Researchers are studying individuals with MEHMO syndrome or related eIF2-pathway conditions, which involve symptoms like intellectual delay, seizures, hormone and blood sugar abnormalities, and reduced motor skills. This observational natural history study aims to better understand the disease progression and identify markers to monitor these rare conditions, as no treatments currently exist. The study also seeks to develop tools for diagnosis, severity rating, and future research resources. Participants include affected individuals, carriers, and unaffected family members. The study involves general health assessments, imaging, laboratory tests, and collection of samples such as blood, urine, spinal fluid, and skin biopsies. Data and biomaterials will be collected longitudinally to compare affected, carrier, and unaffected groups. Throughout the study, participants will undergo evaluations to characterize disease presentation and identify biomarkers. Researchers will assess the feasibility of study procedures and develop severity scales. A repository of participant data and samples will be created to support future research. The study is ongoing and follows participants over an extended period with regular assessments.

Researchers are evaluating the prevention of venous thromboembolism VTE in patients with spinal cord injuries SCI during the acute and sub-acute phases. This study compares the use of Apixaban versus Enoxaparin, which is the usual prophylactic anticoagulant treatment. The purpose is to assess which treatment better prevents blood clots in this patient population, with monitoring of clot formation and bleeding risks. The study is sponsored by Loewenstein Hospital and involves randomized assignment to treatment groups without masking. Participants in the sub-acute phase of SCI rehabilitation will receive either Enoxaparin at a dose of 40 mg once daily or Apixaban at doses between 2.5 mg and 5 mg twice daily, determined by the treating physician. Treatment duration depends on injury severity 6 weeks for AIS grades C-D and 12 weeks for AIS grades A-B. The study includes two groups one receiving Apixaban and the other Enoxaparin, both administered as drug treatments during the specified periods. Throughout the study, participants will undergo evaluations every two weeks, including D-Dimer tests to detect blood clots and ultrasound Doppler scans at the beginning and end of treatment to assess VTE presence. Bleeding events will be recorded, and hematocrit levels monitored regularly. The primary outcome is the number of participants who develop VTE over two years, while secondary outcomes focus on bleeding events within 6 to 12 weeks. Participants remain under medical supervision for the studys duration, which started in September 2023 and is expected to end by February 2026.

Researchers are evaluating the safety of a procedure called cord dose escalated spine stereotactic radiosurgery CDE-SSRS in patients with metastatic epidural spinal cord compression MESCC. This study specifically aims to keep the risk of non-functional paresis, defined by the McCormick score as Grade D, at no greater than 1%. Secondary goals include assessing pain control, quality of life, symptom burden, overall survival, toxicity, walking ability, and cost-effectiveness using various patient questionnaires and MRI scans. The treatment involves a non-invasive, precise radiation procedure called stereotactic radiosurgery given in a single session. This radiation targets cancer in the spine while avoiding surrounding healthy tissue. The radiation dose is carefully adjusted based on the tumors proximity to the spinal cord or cauda equina to achieve effective treatment while protecting critical areas. Participants must have up to three contiguous vertebral levels involved and be able to receive the planned radiation dose safely. Participants will be monitored through regular MRI scans and assessments including pain inventories and quality of life questionnaires. Researchers will track safety and adverse events during the study, which spans an average of one year. The study involves signing informed consent and includes evaluations of motor strength and functional status. The study is sponsored by M.D. Anderson Cancer Center and started in November 2024, continuing through December 2029.

Researchers are evaluating the Single-item Sleep Quality Scale SQS, a simple tool for patients to self-assess sleep quality over a 7-day period, in people with spine disorders like low back pain. This study aims to translate and adapt the SQS into German and Italian and test its accuracy, reliability, and responsiveness in this patient group. Sleep is important for managing spine conditions, but has not been well studied in this population, so a validated, easy-to-use sleep questionnaire is needed. The study is conducted in two stages. First, the SQS will be translated and culturally adapted from English into German and Italian. Then, patients with spine disorders will complete the pre-final and final versions of the SQS along with the Pittsburgh Sleep Quality Index PSQI to assess validity and reproducibility. Patients will complete the SQS multiple times before treatment and again 3 months after either surgical or conservative treatment. This process will evaluate how well the SQS measures sleep quality and detects changes over time. Participants will fill in questionnaires at scheduled visits including before treatment and at 3 months follow-up. Researchers will monitor how clear and relevant the translations are, and compare SQS results with PSQI scores. They aim to confirm the SQS as a reliable, responsive tool for assessing sleep quality in spine patients. The study includes interviews to improve the translations and uses patient self-reporting without invasive procedures. Total participation duration varies but includes initial and follow-up assessments over several months.

Researchers are investigating markers of musculoskeletal health to understand complications in spinal surgery for patients with degenerative diseases of the thoraco-lumbo-sacral spine. This multicenter study, funded by the European Union and the Ministry of Health, aims to address the significant problem of surgical complications, which occur in 7 to 20% of cases and impact both patients and healthcare systems. The goal is to improve surgical decisions and reduce adverse events by identifying important health markers. The study involves comprehensive preoperative screening combining advanced imaging techniques, including HRpQCT scans to assess bone microstructure and computational analysis of bone strength. It also evaluates physical fragility by measuring muscle strength and balance, along with cellular and molecular tests of bone and muscle interaction, and nutritional assessments. These evaluations will help define surgical suitability and guide patient-specific interventions such as nutritional support or physical preparation before surgery. Participants will undergo assessments including radiological imaging, collection of biological samples at baseline, six months, and twelve months, and evaluations of pain, quality of life, and nutritional status over two weeks from the start. The study tracks these measures to understand their relationship with post-surgical complications. Participation lasts at least 12 months, with follow-up visits to monitor outcomes and support surgical decision-making.