Current Clinical Trials
The overall goal of our research program is to improve the function and quality of life of persons with disabilities. This requires that the programs address significant needs in a manner that insures safety and efficacy. The safety and protection of our research participants is the foundation of the development of all our clinical research protocols and procedures. We understand that there is no greater statement of trust and clinical need than when a person enrolls in human research.
Understanding of clinical needs and significance stems from our FES clinician team members and our Consumer Advisory Board. These individuals insure that projects are clinically relevant and project goals are in line with the needs of our constituency groups.
Within each of the active clinical protocols, real human needs are being addressed to bring research and technology advances into the clinic. Regulatory oversight is addressed through dedicated staff working with the individual investigators. Leading the charge with the research community, the FES Center continues to expand and review these human subject programs for quality, consistency, safety and significance.
To accelerate the translation of experimental therapies into “standards of care”, the Cleveland FES Center investigators conduct clinical trials. Clinical trials are organized studies conducted with individuals as research volunteers. The studies are designed to answer specific questions about new therapies or about new ways to use standard therapies. When new treatments are designed, researchers must demonstrate to colleagues and clinicians how the new treatment compares to standard treatment. Once clear results are obtained, researchers communicate their findings to medical and rehabilitation professionals through research reports and publications.
A “protocol” is a set of rules for how the study will be conducted. Researchers design the protocol so that it will clearly answer a research question in a way that can be generalized to apply to other persons with the same medical condition. Each clinical trial has a protocol that specifies the length of the study, the schedule of tests or interventions, how the results are to be measured, and inclusion criteria that define the type of people included in the study. Examples of inclusion criteria are type of injury, time since injury, age, gender, etc. For further information about how clinical trials are carried out, see www.clinicaltrials.gov.