Clinical research is focused on new treatments that improve the quality of life of our patients. Many of our patients experience long-term disability because of their injury or disease process. It is our goal to help each patient achieve their maximum potential through our established treatment regimens as well as through our clinical research studies.
Our previous clinical trials have included studies on new treatments for spasticity from spinal cord injury, improving cognitive functions in stroke and head-injury patients, the use of botulinum toxin for post-stroke spasticity and pain management, and new treatment regimens for chronic pain.
Anne Bonnett, RN, CCRC, is the Clinical Research Coordinator for the department. Anne coordinates each clinical trial and assists the physicians with patient study visits. Anne also communicates with the study sponsors and maintains study records for each trial.
We are grateful for the participation of our patients in these clinical trials. You may benefit from our efforts to advance science and medicine through research. If you are interested in volunteering for a clinical trial, see below for details about the clinical trials open for enrollment at this time.
Current PM&R Studies
DIRECTION STUDY
THE DIRECTION STUDY: HELP US UNDERSTAND UPPER LIMB SPASCITY (ULS)
The DIRECTION study is a clinical research study for adults with Upper Limb Spasticity. The purpose of the study is to learn about the safety and efficacy of a drug called Dysport® when it is compared with another drug called Botox® for upper limb spasticity treatment. Participants are sought for this clinical trial who have spasticity in one arm related to stroke, cerebral palsy, brain, or spinal cord injury.
You could take part in the DIRECTION Study if you:
- are male or female aged between 18-75 years
- have had stable ULS for at least 3 months
- have muscle tightness in elbow, wrist, and fingers of one arm in need of treatment
- able to attend up to 16 clinic visits between 25 and 51 weeks in Columbia, MO
- meet additional criteria
There is no cost to you to participate. You will receive compensation to help cover your travel expenses. This trial will be conducted in PM&R Clinic at Rusk Rehabilitation Hospital by Joseph Burris, MD
For more information:
On the Web: http://www.clinicaltrials.gov
Study# NCT04936542
Contact: Anne Bonnett, RN
Email: bonnetta@health.missouri.edu
Phone: 573-884-6119
PATTERN STUDY
A POST-STROKE or TBI SPASTCITY CLINICAL TRIAL
The PATTERN study is investigating a treatment called NT 201 in treating muscle tightness in the lower leg and ankle caused by stroke or traumatic brain injury in adults three or more months ago.
To participate you must:
- between 18 and 85 years of age
- weigh at least 110 pounds
- able to stand assisted or unassisted
- attend up to 20 visits over 92 weeks in Columbia, Missouri
- have tests to measure your muscle tightness
- have injections into your leg muscles
- meet additional criteria
There is no cost to you to participate. You will receive compensation to help cover your travel expenses. The trial is being conducted by Joseph Burris, MD at PM&R Clinic at Rusk Rehabilitation Hospital.
For more information:
On the Web: http://www.clinicaltrials.gov
Study# NCT03992404
Contact: Anne Bonnett, RN
Email: bonnetta@health.missouri.edu
Phone: 573-884-6119
RESTORE Global SMA Registry
A Study for Patients with Spinal Muscular Atrophy (SMA)
RESTORE is a study of patients who have been diagnosed with spinal muscular atrophy (SMA). Approximately 500 patients with SMA from around the world will be enrolled. Participants who take part will continue to receive their usual standard care treatment from their doctor.
During the study, information provided will help doctors better understand how different treatments affect people who have been diagnosed with SMA. The study will look at how effective different treatments are in the long term, and how SMA and treatment affect the health and quality of day-to-day life. By joining the RESTORE Global SMA Registry, participants will be helping advance our understanding of SMA so we can improve patient care.
What will patients/caregivers be required to do to participate?
By agreeing to take part in the study, patients/caregivers will:
- Receive standard treatment for their SMA, no special medication or study visits will be required
- Attend appointments as usual
- Complete a patient and parent/legal guardian Informed Consent Form
- Complete questionnaires periodically through a web app
The SMA Registry Study at the University of Missouri is being conducted by Jane Anne Emerson, MD in the Department of Physical Medicine and Rehabilitation. If you would like information about the RESTORE SMA Registry, please contact Study Coordinator, Anne Bonnett, RN at 573-884-6119 or bonnetta@health.missouri.edu
PREMIER STUDY
PREMIER is a Phase III clinical study of the investigational drug PXT3003, a treatment for the CMT1A.
This Charcot-Marie Tooth Disease (CMT1A) clinical trial is currently in progress in the Department of Physical Medicine and Rehabilitation under the direction of Dr. Vovanti Jones, MD. Study enrollment was completed in June 2022. Subjects continue their double-blind treatment and quarterly follow-up visits in the PM&R clinic with Dr. Jones where several outcome measures are performed at each visit. The double-blind treatment period is 15 months followed by and open-label extension period for subjects choosing to continue with study participation. The Sponsor intends to keep the study open until the study drug PXT3003 is commercially available.
