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Spinal Cord Injury clinical trials

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NCT ID: NCT00535210 Terminated - Spinal Cord Injury Clinical Trials

The Effect of an Exercise Program on Physical Function After a Spinal Cord Injury

Start date: September 2007
Phase: N/A
Study type: Interventional

This study would focus on adding a group exercise program to the usual therapy delivered in the hospital. We propose to design an exercise program that would be 30 minutes in length, 3 times per week. A medical doctor and physiotherapist would oversee the design and monitoring of the program. We believe that this program will: 1) Increase the potential for better health, thus improving independence and quality of life; 2) Help people make the move from therapist run exercise to self management of exercise; 3) Engage the patient in the therapy process and place an expectation of active participation on the client; and 4) Promote physical activity as part of a healthy lifestyle.

NCT ID: NCT00507546 Completed - Insomnia Clinical Trials

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Start date: July 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.

NCT ID: NCT00500812 Completed - Spinal Cord Injury Clinical Trials

A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries

Start date: February 2005
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: those with a complete cervical injury or a complete thoracic injury. Dose levels from 0.3 mg - 9 mg of Cethrin will be administered.

NCT ID: NCT00488969 Recruiting - Spinal Cord Injury Clinical Trials

Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury

Start date: July 2007
Phase: Phase 2
Study type: Interventional

We would like to learn if a medicine called "modified-release morphine sulfate" (Avinza) helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time. "Modified-release" means that the medicine in the capsules is slowly released to the body, instead of being released all at once. Avinza is approved by the Food and Drug Administration for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related pain.

NCT ID: NCT00475748 Active, not recruiting - Spinal Cord Injury Clinical Trials

Surgical Management of Spinal Cord Injuries In Neck

CCSS
Start date: May 2007
Phase: Phase 2
Study type: Interventional

ABSTRACT/EXECUTIVE SUMMARY BACKGROUND, SIGNIFICANCE & RATIONALE: Between 10-20% of the more than 6000 cases of spinal cord injury seen annually in the North America have the clinical pattern of traumatic central cord syndrome (TCCS). These patients are usually older, most likely have sustained a fall, and have incomplete spinal cord injury characterized by dysesthetic and weak upper extremities. CT scan of the cervical spine in patients with TCCS often shows disc/osteophytes complex superimposed on degenerative or congenital spinal stenosis and MRI reveals signal changes at one or multiple skeletal segments. A minority of these patients suffer from fracture/subluxations, however, this group of patients are younger and have been involved in a more dynamic trauma. Since 1951, when Schneider et al reported this syndrome, controversy has dominated its surgical management. The current "Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries" recommendations are only at the level of options, since prospective outcome data are unavailable. HYPOTHESIS: in acute traumatic central cord syndrome, surgical decompression of the spinal cord within five days will result in more rapid motor recovery, than decompression 6 weeks following injury. To test this hypothesis, we will pursue the following specific aims: SPECIFIC AIM I: To compare American Spinal Injury Association (ASIA) Motor Scores after three months post injury in patients with central cord syndrome operated on within five days of injury to a similar group of patients operated on 6 weeks following injury. SPECIFIC AIM II: To compare functional outcome, health related quality of life and posttraumatic syrinx size in patients with traumatic central cord syndrome operated on within five days to a similar group of patients operated on 6 weeks following injury. DESIGN: Single center prospective randomized study. PROCEDURE: In a two-year period thirty patients with traumatic central cord syndrome and cord compression (15 patients in each group) will be randomized to undergo surgical decompression either within the first five days or at 6 weeks following spinal cord injury. ASIA motor, functional recovery and health related quality of life between the two groups will be compared at admission, discharge from rehab facility 3 months and 12 months after surgery.

NCT ID: NCT00472784 Withdrawn - Spinal Cord Injury Clinical Trials

Quantitative and Qualitative Changes in Neural Efferent Receptors

Start date: October 1998
Phase:
Study type: Observational

OBJECTIVE: 1. To study tissues from spinal cord injured patients with noncompliant bladders as well as neurologically intact patients with normal bladder compliance, analyzing both quantitative and qualitative neural efferent receptors, collagen, and smooth muscle contents, using RT-PCR and electron microscopy. 2. To explore the possible shift in bladder neural architecture after SCI from beta to alpha-adrenergic receptors. RESEARCH DESIGN: 25 spinal cord injury patients who underwent cystoscopic procedures will be included in this study. 25 control patients without spinal cord injury and already scheduled for urologic procedures will also be included in this study. METHODOLOGY: Study patients will undergo flexible or rigid cystoscopy as well as selective cold cup biopsies of the posterior and lateral walls, and trigonal area of the bladder. Control patents will undergo cystoscopy and selected bladder biopsies preceding their scheduled urologic procedures. Tissue samples will be frozen for later EM and RT-PCR analysis of collagen, smooth muscle, and efferent adrenergic receptor content and subtype. Hemostasis will be achieved with a cautery electrode. Criteria of exclusion include active urinary tract infection identified by preoperative urinalysis, or the presence of suspicious lesions seen during cystoscopy. Suspicious areas will be biopsied and the patient will be excluded from the study. Subjects will be given a preoperative dose of Rocephin 1g IM as well as a postoperative 3-day course of Cipro 500 mg BID. Control patients will be given standard perioperative prophylactic/empiric therapy as indicated for their urologic procedure. Patients will be followed in 1-2 weeks to evaluate their postoperative course. FINDINGS: Total number of subjects enrolled: 43. 12-03: To date we have not encountered any problems with the study and health wise the subjects have done fine. No adverse events have been reported. Preliminary Results: The tissue is currently being analyzed - mRNA by microchip analysis and the data is still being worked on to look for correlations in genes up or down regulation versus the morphological EM findings previously reported.

NCT ID: NCT00448045 Completed - Spinal Cord Injury Clinical Trials

Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury

Start date: June 2007
Phase: Phase 2
Study type: Interventional

It is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal muscles that are vital to deep breathing and the ability to cough. The purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with SCI. This is a randomized controlled trial investigating the effectiveness of two different treatments. Participants will be randomly assigned to one of the two treatment groups. They will not be told the details of the other intervention since this could influence or change their activities during the study.

NCT ID: NCT00434018 Completed - Spinal Cord Injury Clinical Trials

Enhancing Indoor, Community, and Advanced Wheelchair Skills in Spinal Cord Injury (SCI)

Start date: April 2008
Phase: Phase 2/Phase 3
Study type: Interventional

We propose to test an evidence-based wheelchair skills training program to optimize wheelchair safety and performance in veterans with SCI. The proposed training program incorporates emerging evidence on wheelchair biomechanics and motor-skills learning, and addresses recommendations in a new clinical practice guideline. Given the difficulty in translating wheelchair skills learned in a therapy clinic with "real world" problems in the home and community post-discharge, we are proposing to conduct the wheelchair skills training in and around the veteran's home. The immediate goal is to enhance ability, performance time, safety, community participation, and quality of life, while minimizing physical strain. The ultimate goal is to reduce morbidity/mortality associated with wheelchair use and promote successful aging with a disability.

NCT ID: NCT00432289 Completed - Spinal Cord Injury Clinical Trials

Acupuncture for Treatment of Acute Spinal Cord Injury: an Exploratory/Developmental Study

Start date: November 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Specific Aim: to implement and evaluate a research protocol for demonstrating the efficacy of Acupuncture Therapy to improve neurological recovery after incomplete SCI compared to a control protocol. Hypothesis: acupuncture treatment results in greater neurological recovery than a control treatment after an incomplete SCI. Before conducting a larger, more definitive study, this exploratory and developmental work is focused on assessing whether blinding is possible, reproducibility of the outcome measure, determine enrollment rates and effect sizes and identify clinical resources needed to conduct a larger study.

NCT ID: NCT00426842 Completed - Spinal Cord Injury Clinical Trials

A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride

Start date: January 2007
Phase: Phase 2
Study type: Interventional

With upright postures, there is an immediate redistribution of blood to the dependent circulation; venous return and central venous filling pressure are reduced, resulting in diminution of cardiac output and blood pressure. These hemodynamic alterations stimulate the baroreceptor reflex, which is mediated via the central nervous system to increase peripheral sympathetic vasomotor tone, restoring blood pressure and cardiac output within seconds-to-minutes of the assumption of the upright position. Following SCI, individuals often experience the inability to adjust to postural changes due to disruption of central command of the baroreceptor reflex and reduction in efferent sympathetic neural pathways; consequently, orthostatic hypotension (OH) and symptoms of cerebral hypo-perfusion may ensue. OH is a well-documented phenomenon, which is characterized by a fall in systolic blood pressure of >20 mmHg or diastolic BP of > 10 mmHg within 3 minutes of assumption of an upright posture. As a consequence of OH, many individuals experience symptoms of cerebral hypo-perfusion which include lightheadedness, dizziness, blurry vision, fatigue, nausea, ringing in the ears, cognitive impairment and heart palpitations. Although several investigators have reported increased prevalence of OH during the acute phase of spinal cord injury (SCI), individuals with chronic injury also experience significant falls in blood pressure with seated upright postures. This investigation will examine the effects of an alpha-agonist, midodrine hydrochloride, during head-up tilt on systemic blood pressure, cerebral blood flow and cerebral oxygenation compared to placebo administration in persons with chronic SCI who demonstrate significant orthostatic hypotension during a 24-hour observation study. This is the first study to determine the dose response and efficacy of midodrine to improve orthostatic blood pressure and cerebral blood flow and oxygenation in the SCI population.