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Clinical Trials, Studies & Research Surveys
Published on 09/22/2005
Page 1

Clinical Trials, Studies & Research Surveys

CLINICAL TRIALS:

CenterWatch Clinical Trials Listing ServiceCenterWatch Clinical Trials Listing Service
A wealth of information related to clinical trials, such as a listing of more than 41,000 industry and government sponsored clinical trials as well as new drug therapies. Designed to be a resource both for patients interested in participating in clinical trials and for research professionals.

ClinicalTrials.govClinicalTrials.gov
The U.S. National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies.

RehabTrails.orgRehab Trails
Information for patients and caregivers on new clinical trials with news and announcements. Also contains a search utility, newsletter, FAQs, articles, and resources.

The Mount Sinai Medical Center and Kessler Institute for Rehabilitation Are Now Enrolling for Proneuron's Phase II Study of ProCord for Neurologically Complete Spinal Cord Injury

Update: "Proneuron has recently created a new web site for SCI patients and their families to learn more about enrollment into the Company's Phase II clinical trial for ProCord procedure for complete SCI. The URL is www.spinalcordtrial.com."

The Mount Sinai Medical Center (NYC) and Kessler Institute for Rehabilitation (West Orange, NJ) are now enrolling for Proneuron's Phase II trial of ProCord, for complete spinal cord injury. The official announcement was made at the Rally For the Cure, at the Winter Garden Financial Center in New York City.

"This collaborative effort between leading centers of care for persons who have sustained a spinal cord injury is a testimony to the importance of how 'working together we can make things happen'. This is the message for all professionals involved in the care of spinal cord injury," said Dr. Steven Kirshblum, Principal Investigator and Director of Spinal Cord Injury Service, Kessler Institute for Rehabilitation.

Patients found eligible for the study will be randomly assigned to either a treatment or control group. Patients in the control group will not receive the study treatment. All control and treatment patients will receive standard spinal cord injury care and rehabilitation and will receive follow-up testing for one year.

"We selected this venue to jointly announce the launch of this trial at our centers to draw attention to the importance of collaboration if we are to be successful. We need everyone to spread the word to doctors, family and friends so that we can reach people in the crucial first few days after their injury," said Dr. Kristjan Ragnarsson, the Principal Investigator and head of the Department of Rehabilitation Medicine at Mount Sinai.

This international, multi-center, randomized-controlled, experimental study is open to patients who meet eligibility criteria, including but not limited to an ASIA Grade A injury between C5-T11 vertebrae, within 14 days of injury. Asia Grade A is defined as patients who have no feeling or movement below the point of injury.

Email: clinical.trial@proneuron.com
Telephone: 1 866 539 0767 (U.S. toll free) or 1 506 652 3486. 
Fax: 1 866-214-7078 
- Callers outside of the U.S., please use standard international dialing code

For additional information: www.proneuron.com
 

PETITIONS

The OEG Petition
OEG Petition: Move OEG (Olfactory Ensheathing Glia) Transplants Into Human Clinical Trials for Spinal Cord Injury.Move OEG (Olfactory Ensheathing Glia) Transplants Into Human Clinical Trials for Spinal Cord Injury. OEG is a promising experimental cell therapy for spinal cord injury. The scientific evidence proves OEG research is ready to move into human clinical trials. OEG therapy is a safe and effective cell transplant for the restoration of function in SCI.
  

STUDIES:

Research Participants Needed for Spinal Cord Injury and Chronic Pain Study

University of Alabama at Birmingham (UAB) Department of Physical Medicine and Rehabilitation

The purpose of this UAB study is to investigate the contribution of cognitive appraisal, coping, activity restriction, and social support in the relationship between pain and depression among persons with spinal cord injury.  We hope that you will participate in this important study and complete a one-time telephone survey, which will take between 45-75 minutes.  You will receive a $25 Wal-Mart gift card for your time.

Eligibility Criteria:

  1. Diagnosis of SCI
  2. Age 19 or older
  3. At least 1 year post-onset SCI
  4. No pre-injury pain or depression requiring formal treatment
  5. Self-reported pain for at least 6 months

If you are interested in participating and want additional information, please contact:

Michael W. Wilson, M.A., Principle Investigator
J. Scott Richards, Ph.D., Co-Principle Investigator
Toll Free Ph: 1-877-686-5300
Local Ph: (205) 934-4462
E-mail: mwwilson@uab.edu

IRB # 00000726
 

Health Interventions for Survivors and Primary Support Persons of Spinal Cord Injury

Study Description: It is now common for individuals with spinal cord injury and disability (SCI/D) to have life expectancies similar to those of non-injured persons.

As people with SCI/D grow older, they face unique challenges in adapting to aging. Those who provide support for the SCI/D survivor also face difficult life challenges. The purpose of this research study is to develop and evaluate new ways of assisting middle-aged and older persons living with the long-term effects of SCI/D.

This research study is supported by the National Institutes of Health and will be carried out in two locations: Pittsburgh, Pennsylvania; and Miami, Florida. Approximately 250 persons with spinal cord injury, as well as those that provide SCI/D survivors with primary support, will be enrolled into the study. Those who agree to participate will be assigned to one of several intervention groups. The duration of intervention for all groups will be six months.

Depending upon group assignment, the health interventions provided by the study will include: information and education on aging and SCI/D; focused training on managing physical and emotional health issues related to living with chronic disability, training in communication skills, and opportunities for peer and professional support and advice. All participants will receive a risk assessment addressing physical and emotional well-being, safety, and social support.

In addition to participating in an intervention group, all participants will complete three assessments to be carried out by a trained interviewer. The first assessment will take place before the intervention begins, the second will take place 6 months later when the intervention is completed, and the third assessment will take place 12 months after the initial assessment. Participants will receive $25 for each completed assessment. By comparing the assessments across intervention groups, we will be able to determine which intervention is most effective in helping caregivers and their care recipients.

If you are interested in participating in this study, or would like more information, please contact Trinidad Argüelles, SCI/D Senior Research Associate, at (305) 355-9053.

Functional Electrical Stimulation Induced Bicycling in Chronic Spinal Cord Injury

Researchers at The Department of Physical Medicine and Rehabilitation at The University of Cincinnati are looking for individuals who have experienced a compromise in the function of their legs as a result of a spinal cord injury. We are conducting a study that tests the effects of functional electrical stimulation on walking and balance.

We are looking for people who:

  • Are between the ages of 18 and 55
  • Experienced their SCI more than one year prior to study enrollment
  • Normal passive range of motion in the lower limbs
  • No excessive spasticity in the lower limbs

What to expect:

  • Upon arrival, you will be asked about your general medical history.
  • Your range of motion, pain, muscle stiffness, and muscular activity in your legs will be evaluated
  • Your gait will be evaluated
  • You will be asked to participate in the 10-week intervention using the stimulation bicycle at our dedicated research space at the Drake Center. You will also be given a standard, lower limb exercise regimen including stretching and strengthening components, and a diary to monitor compliance.

Your confidentiality will be completely respected, and if the findings from the study are published, you will not be identified by name. You may, at any time, discontinue your participation. 

If you are interested in participating in this study or would like more information, please contact:

Steve Page, Ph.D.
Department of Physical Medicine and Rehabilitation,
University of Cincinnati
Stephen.Page@uc.edu 
Website: www.rehablab.org
513-558-2754

Social Support & Paralysis Study

The University of Nevada, Reno is conducting a study sponsored by CDC to examine social support in adults with paralysis. People with paralysis report lower levels of support compared to the general population. For this study, we are interested in exploring factors that might explain this difference and how we can improve support.

In order to do this we need to hear from you! Participation in the study is completely voluntary and all information is strictly confidential. If you are interested, please visit our website at www.supportandparalysis.org or call us toll-free at 1-866-317-8431.

STUDY (Syracuse, NY)

Rehabilitation After Spinal Cord Injury: Which Method Is Better for Improving Walking and Balance?

This NIH funded study tests methods that may improve walking in people with incomplete spinal cord injury. The study compares the "body weight support (BWS)" method of training on a treadmill, versus BWS training on a track, versus comprehensive physical therapy. Subjects are randomly assigned to one of these three training groups, and train three times a week for an hour each session, for a total of thirteen weeks.

The total commitment for each subject will be about fourteen weeks, because of some pre- and post-testing that is necessary, and will all take place in the lab at SUNY Upstate Medical University in Syracuse, NY. Blair Calancie, PhD, is the principal investigator, and began the study three years ago under "The Miami Project to Cure Paralysis," at the University of Miami School of Medicine.

Participation is open to men and women 16-70 years old, with a traumatic, incomplete spinal cord injury at the T10 level or above, from greater than one year previously. Subjects must have some voluntary movement in one leg. For more information, please call Rosemary Merola at (315) 464-9943, or send and e-mail to alexeevn@upstate.edu.



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