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Spinal Cord Diseases clinical trials

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NCT ID: NCT04004819 Recruiting - Clinical trials for HTLV-1-associated Myelopathy

Rituximab for HTLV-1-associated Myelopathy

Start date: August 15, 2019
Phase: Phase 2
Study type: Interventional

Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.

NCT ID: NCT03950349 Recruiting - Clinical trials for Cervical Radiculopathy

FUSION EVALUATION AFTER ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH STAND ALONE LOCKING CAGE WITH BLADE HRCC®

Start date: January 1, 2019
Phase:
Study type: Observational

Cervical degenerative disease is an almost universal concomitant of human aging. Over half of the middle aged population has cervical spondylosis. This condition is often asymptomatic, but in 10% to 15% of the cases, it is associated with, or progresses to, neural compression. Cervical spondylotic radiculopathy is a condition due to a root nerve compression while cervical spondylotic myelopathy is a condition due to a medullar cord compression. Root nerve or medullar cord can be compressed either by a soft disc extrusion or by arthrosis due to a degenerative disc. Anterior cervical discectomy and fusion is the standard surgical treatment of the cervical radiculopathy or cervical myelopathy when non-surgical treatment failed. The aim of this surgery is to provide a neurologic decompression associated to spine stabilization. Decompression is achieved by removal the disc and soft disc extrusion if present. Stabilization is supported by implantation of material in the interbody space like bone or cage with bone substitute. This cage provides a bone fusion matrix and an intervertebral height and stability support at the same time. To enforce the stabilization, a plate can be screwed on the anterior cervical vertebral wall. The HRCC® cage is a stand-alone cage with two rotary blades which penetrate into vertebral bone so there is no need to implant plate. One of the reasons why treatment can fail is the pseudarthrosis that is fusion failure. It mays occur as an increase of axial pain or radicular pain. The aim of this study is to demonstrate similar results on bone fusion in the surgical treatment of cervical radiculopathy or myelopathy with HRCC cage used in anterior cervical discectomy and fusion compared with other technics based on a prospective cohort study and a literature review. As secondary outcomes we will search to correlate pseudarthrosis and quality of life impact, to identify complications and to describe the sagittal balance evolution of the cervical spine. To this end, in the context of standard practices, patients who consult the neurosurgical team of the REIMS University Hospital Center with a diagnosis of a cervical radiculopathy or myelopathy with non-surgical treatment failure needing a one level anterior cervical discectomy and fusion will be proposed to be included during this pre-operative consultation. There will be pre-operative collected data about demographic data, pseudarthrosis risk factors, pre-operative symptomatology, quality of life data and pre-operative imagery data. Per-operative and hospitalization data are collected as well with surgery duration, blood lost, surgical technic, pain measurement and hospitalization duration. Next, follow-up starts with consultations at 6 weeks, 6 months and 12 months and pain, quality of life and classic X-Ray data are collected to be compared with pre-operative data. And Imagery data are collected in order to identify presence or absence of pseudarthrosis with dynamic X-Ray and CT-scan at 6 months and 12 months. A statistical analysis of the data is next performed to found significant results.

NCT ID: NCT03922802 Recruiting - Clinical trials for Spinal Cord Injuries

SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

This is a single blind, sham controlled crossover trial that will evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals after spinal cord injury.

NCT ID: NCT03842072 Recruiting - Clinical trials for Cervical Radiculopathy

The Collar Post Anterior Cervical Spine Surgery Study

C-PASS
Start date: February 23, 2018
Phase: N/A
Study type: Interventional

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position. Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.

NCT ID: NCT03810781 Completed - Clinical trials for Cervical Spondylotic Myelopathy

Postural Stability in Cervical Spinal Myelopathy

Start date: February 7, 2019
Phase:
Study type: Observational

Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from rigors of military service. Balance and posturography are negatively affected in CSM, but require expensive equipment, and extensive training of personnel for data acquisition and interpretation. The Virtual Environment TBI Screen (VETS) is a simple and inexpensive construct that could be implemented as an aid in diagnosis and as an objective means to compare treatment modalities and track recovery. The goal for the SPiRE is to generate the critical data to support rigorous Merit studies of posturography for assessments of clinical course in the treatment and rehabilitation of CSM. The investigators' ultimate goal, if the SPiRE is successful, is to phase in objective posturography assessments as VA standard of care in CSM.

NCT ID: NCT03695848 Completed - Cervical Myelopathy Clinical Trials

Prognostic Value of DTI and fMRI of Cervical Myelopathy

CSM
Start date: September 26, 2018
Phase:
Study type: Observational

Cervical myelopathy (CM) is one of the most common degenerative spinal cord disorders affecting older people. The progression of CM is insidious and the neurological decline can vary between patients. Surgical decompression is considered the most effective way to treat CM, however, it is not free from risk and the surgical outcome is not always satisfactory. The expected outcome of surgical intervention for CM remains a difficulty. There is a pressing need for a reliable and quantitative approach to predict surgical outcomes of CM and the precise prognosis. Previous studies have suggested a number of prognostic factors, such as age, duration of symptoms, pre-operative neurological status and abnormal MRI, but their prognostic value remains controversial. Recently, diffusion tensor imaging (DTI) and fMRI have been proposed as a promising tool for predicting the surgical prognosis of CM. In previous study, the protocol was successfully established for DTI microstructural characterization and resting state fMRI of the cervical spinal cord. This study is to evaluate the value of DTI and fMRI in predicting the outcome of surgical treatment. The ultimate goal is to establish a clinical protocol for quantitative DTI and fMRI analysis that could give accurate prognosis for surgical intervention to CM.

NCT ID: NCT03665935 Not yet recruiting - Myelopathy Clinical Trials

Diffusion Tensor Imaging of Myelopathy

DTI
Start date: September 2018
Phase:
Study type: Observational

Myelopathy describes any neurologic deficit related to the spinal cord. Myelopathy is caused by various pathological states of the human spinal cord, including tumors, inflammatory lesions, spinal cord compression and degenerative myelopathy. Clinically, the diagnosis of myelopathy depends on localization of the neurologic finding to the spinal cord, rather than the brain or peripheral nervous system and then to a particular segment of the spinal cord. Magnetic resonance imaging (MRI) plays an essential role in the diagnosis and follow-up of the lesions of the spinal cord using conventional MRI T1- and T2-weighted sequences. Sometimes a studied spinal cord may appear normal on conventional MRI even though patients have symptoms of myelopathy causing a discrepancy between MRI findings and clinical findings. Diffusion tensor imaging (DTI) is an advanced non-invasive MR imaging technique which assesses the microstructural integrity of nerve fiber tracts.

NCT ID: NCT03644407 Recruiting - Scoliosis Clinical Trials

Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring

SPINEREG
Start date: November 10, 2015
Phase:
Study type: Observational [Patient Registry]

The SPINEREG study is a prospective observational registry. Eligible patients are subjects undergoing spine surgery at the participating institutions. Baseline health status and follow-up health status are recorded at pre-established steps.

NCT ID: NCT03618589 Recruiting - Pain, Neuropathic Clinical Trials

Pregabalin add-on for Neuropathic Pain in Cervical Myelopathy

Start date: November 26, 2016
Phase: Phase 1
Study type: Interventional

There is no information on the effect of pregabalin in patients with neuropathic pain in cervical myelopathy under routine clinical practice. The investigators will conduct this prospective, randomized trial to determine the efficacy of pregabalin for neuropathic pain in cervical myelopathic patients in order to validate or refute this popular practice. The primary aim of this study was to compare Leeds assessment of neuropathic symptoms and signs scale (LANSS) scores of neuropathic pain in cervical myelopathy patients.

NCT ID: NCT03591497 Completed - Virtual Reality Clinical Trials

Role of Virtual Reality in Improving Balance in Patients With Myelopathy

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Balance of the body is achieved by the coordination of three major systems, visual, vestibular and proprioceptive sensation and by the reflexive control of the limbs. In myelopathy, factors like balance and posture, range of motion, muscle strength, coordinated motor control, muscle tone and proprioception are affected. Balance and gait rehabilitation is an important goal in myelopathy. Virtual reality (VR) is a computer based technology that is used for task oriented biofeedback therapy in rehabilitation. This study was envisioned to observe the utility of VR in rehabilitation for improving balance in patients of myelopathy.