A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy.

Date Added
September 12th, 2023
PRO Number
Pro00128912
Researcher
Josef Eichinger

List of Studies


Keywords
Drug Studies, Joint, Muscle, Pain
Summary

Patients greater than/equal to 18 years of age who are diagnosed with unilateral rotator cuff tendinopathy (with MRI confirmation) will be recruited. The purpose of the study is to measure the safety and efficacy of the drug secukinumab, 300mg s.c. (subcutaneous) compared to placebo. The use of secukinumab for the treatment of tendinopathy is investigational in this study, but FDA approved for other indications. The study will be a randomized, double-blind study. This means the participant, nor the researchers will know if the drug or placebo is administered. The treatment period will last 16 weeks, during which the patient will receive 7 doses of the study drug (2 injections per dose) over 12 weeks. Participants will continue follow-up until week 24. A total of 11 visits are required for the study, each will take approximately 3 hours to complete. These visits will be at the following timepoints: Screening visit, Baseline visit, and visits at weeks 1,2,3,4,8,12,16, 20, and the end of the study visit. The location of the injection will be the affected shoulder.

Risks include but are not limited to upper respiratory tract infections, with symptoms such as sore throat and stuffy nose. Common risks include Cold sores, Athletes foot, runny nose, diarrhea, itchy rash (urticaria). Rare and serious risks include Severe allergic reaction with shock (anaphylactic reactions). A blood draw may cause fainting, pain, and/or bruising, dizziness, and in rare cases, infection.

Institution
MUSC
Recruitment Contact
Maggie Schiessl
843-792-7534
schiessl@musc.edu

Assessment of cortical network connectivity in individuals with impaired walking coordination post-stroke

Date Added
July 6th, 2021
PRO Number
Pro00111026
Researcher
Steven Kautz

List of Studies


Keywords
Muscle, Non-interventional, Rehabilitation Studies, Stroke Recovery
Summary

Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method often used to assess connectivity between the brain and specific muscles. This research study is aimed at finding the changes in the manner brain communicates with leg muscles post-stroke and its effects on movement coordination during walking.

Institution
MUSC
Recruitment Contact
Shraddha Srivastava
8437926165
srivasts@musc.edu

Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best MCGR Implementation Strategy using Distraction Intervals

Date Added
March 17th, 2020
PRO Number
Pro00092719
Researcher
Robert Murphy

List of Studies


Keywords
Bone, Muscle
Summary

This study aims to study children with Early Onset Scoliosis who undergo implantations of a magnetic growing rod, to see if any differences that exist between lengthening the rod every 6 weeks or 4 months.

Institution
MUSC
Recruitment Contact
Robert Murphy
843-792-9542
murphyr@musc.edu

Direct measurement of motor cortical responses to transcranial direct current stimulation

Date Added
May 15th, 2018
PRO Number
Pro00073545
Researcher
Nathan Rowland

List of Studies


Keywords
Brain, Central Nervous System, Movement Disorders, Muscle, Nerve, Nervous System, Parkinsons, Surgery
Summary

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with motor deficits, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how tDCS affects motor areas in the brain. We propose using tDCS while recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. We expect this novel approach to broaden our understanding of tDCS application and possibly lead to therapeutic advances in this population.

Institution
MUSC
Recruitment Contact
Ayesha Vohra
843-792-6210
vohra@musc.edu

Assessment of Contributions to Impaired Walking after Neurologic Injury

Date Added
January 15th, 2014
PRO Number
Pro00028941
Researcher
Chris Gregory

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Muscle, Nerve, Physical Therapy, Rehabilitation Studies, Stroke
Summary

Rehabilitation interventions including resistance training, functional and task-specific therapy, and gait or locomotor training have been shown to be successful in improving motor function in individuals with neurologic disease or injury. Recent investigations conducted in our laboratory indicate that intense resistance training coupled with task-specific functional training lead to significant gains in functional motor recovery. Similarly, gait rehabilitation involving intense treadmill training and/or task-specific locomotor training has been shown to be effective in improving locomotor ability. However, the underlying neural adaptations associated with these therapeutic approaches are not well understood. Our primary goal is to understand the motor control underpinnings of neurologic rehabilitation in order to apply this knowledge to future generations of therapeutic interventions.

Institution
MUSC
Recruitment Contact
Brian Cence
843-792-2668
cence@musc.edu



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