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Spinal Cord Injury clinical trials

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NCT ID: NCT00654082 Completed - Spinal Cord Injury Clinical Trials

A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

Start date: September 2002
Phase: Phase 4
Study type: Interventional

To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.

NCT ID: NCT00652262 Completed - Spinal Cord Injury Clinical Trials

BAY38-9456 - Supportive Trial for Spinal Injury

Start date: March 2004
Phase: Phase 3
Study type: Interventional

BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective

NCT ID: NCT00645567 Completed - Spinal Cord Injury Clinical Trials

Biomechanics of Wheelchair Transfers

Start date: January 2010
Phase: N/A
Study type: Observational

This is a laboratory-based study to evaluate the risk of shoulder injury associated with transfers between wheelchair and vehicle in persons with spinal cord injury. Four new devices will be compared against an unassisted transfer.

NCT ID: NCT00624806 Completed - Spinal Cord Injury Clinical Trials

Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

Start date: February 2008
Phase: N/A
Study type: Interventional

The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

NCT ID: NCT00594178 Completed - Spinal Cord Injury Clinical Trials

Palliative Strategies in Spinal Cord Injury (SCI)

Start date: October 2003
Phase: N/A
Study type: Interventional

Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. Previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (MBET), in adult spinally transected animals reduced muscle atrophy and normalized hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal transaction, that MBET could also be used to rescue from hyperreflexia once it had set in, and that MBET could induce savings in normalization of reflexes after MBET ceased. We also demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI patient, and that short-term MBET could lead to brief savings in normalization of reflexes once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance to set in. In addition, the proposed research will attempt to confirm the possibility that long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and also produce significant savings in normalization of reflexes if carried out for long periods of time. We will also test the possibility that MBET in acute and/or chronic SCI patients could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans, spasticity measures and electrophysiological measurements to determine low frequency habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass, bone density, spasticity scales and H-reflex habituation will be compared across these interventions and between treated SCI victims and a group of control acute and chronic SCI victims undergoing standard of care during the same period.

NCT ID: NCT00573976 Completed - Spinal Cord Injury Clinical Trials

Study to Assess the Validity and Reliability of the Spinal Cord Independence Measure (SCIM III)

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

In the past two decades there have been great strides made in understanding the biological changes resulting from spinal cord injury (SCI). The future holds promise of the development of therapies that will promote degrees of repair and recovery of function for people living with SCI. Lessons learned from past "failed" SCI clinical trials, however, demonstrate that, in order to accurately evaluate the overall effectiveness of SCI therapies, more sensitive outcomes measures are needed. Specifically, and reflecting the ultimate goal of clinical interventions - inducing functional recovery - the Spinal Cord Independence Measure (SCIM), has been recommended for further testing and development for use as a measure of functional ability in future SCI clinical studies. The SCIM is a very simple questionnaire and score sheet that an evaluator uses to determine how independently a person with SCI can perform certain tasks. A panel of SCI researchers recommended the SCIM as the most suitable among four candidate measures of functional recovery reviewed at a special meeting sponsored by the National Institute on Disability and Rehabilitation Research (NIDRR) at a joint meeting of the American Spinal Injury Association and the International Spinal Cord Society (ASIA-ISCoS) in Boston, MA, in June 2006. It was recommended that a large-scale, multi-center, prospective trial be conducted in the United States, which would mirror a recently published multi-site international study. The proposed research on the SCIM III, the latest and most sensitive version of the SCIM, would test the hypothesis that the SCIM III is a valid, reliable, and sensitive measure of functional ability in persons with SCI. Twenty-two rehabilitation centers throughout the United States will enroll a maximum of 660 subjects. Functional ability will be measured with the SCIM III during the first week of admittance into inpatient acute rehabilitation and within one week of discharge from the same rehabilitation program. Statistical analyses will be used to test the validity, reliability, and sensitivity of the SCIM III. The results will demonstrate whether the SCIM III is a suitable outcome measure to assess SCI specific functional ability in future clinical trials.

NCT ID: NCT00561782 Completed - Spinal Cord Injury Clinical Trials

MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI

MRS
Start date: October 2007
Phase: N/A
Study type: Observational

The goal of this study is to compare the changes that occur in sensation and chemical properties of the brain following SCI between individuals that experience chronic pain and those that do not, and between those with SCI and the able-bodied.

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: 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.