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.

Researchers are evaluating the use of Magnetic Resonance Spectroscopy (MRS) to assess spinal cord lesions in adults. The study aims to establish the feasibility and range of MRS for mapping the entire spine spectrum at short echo times. This will help compare results in patients to assess the malignant potential and grade of spinal cord lesions. The trial also plans to test the reproducibility of the MRS protocol and examine the effects of radiation on the spinal cord over time in patients receiving craniospinal irradiation for leptomeningeal disease (LMD). Participants include healthy adult volunteers and adult patients with low volume LMD undergoing craniospinal irradiation as part of their standard treatment. Both groups will receive MRS scans of the spine using the established protocol. The study is non-randomized and involves implementing the MRS technique on these two groups to gather data on its use and effects. The secondary objective is to provide data for future trials focused on functional status after radiation and tumor grading predictability using MRS. During the study, participants will undergo MRS spine scans and be monitored for safety and any adverse events throughout the study duration, averaging about one year. Researchers will assess the success and reproducibility of the MRS protocol and monitor the impact of radiation on the spinal cord at different times. Participants must consent and comply with study procedures, and safety will be closely followed until study completion.

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 such as intellectual disability, seizures, hormone and blood sugar irregularities, and reduced motor skills. This observational natural history study aims to better understand these rare conditions by identifying clinical and biochemical markers to track disease progression and to improve knowledge about their course and impact. Participants include those diagnosed with MEHMO syndrome or related disorders, carriers of EIF2S3-related variants, and unaffected family members. The study involves regular health assessments, imaging tests, laboratory evaluations, and collection of biological samples including blood, urine, spinal fluid, and skin biopsies. It follows individuals over time to gather comprehensive data and biological materials. During the study, participants will undergo evaluations of their general health and disease symptoms, imaging exams, and various laboratory tests. Researchers will monitor clinical signs and fluid biomarkers to develop a severity rating scale and classification system. The study also aims to build a repository of data and samples for future research. This observational study does not involve any treatment but focuses on detailed monitoring to support future therapeutic development.

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 study's 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 tumor's 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.