Actively Recruiting
Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
Led by University of Mississippi Medical Center · Updated on 2024-07-01
16
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
Sponsors
U
University of Mississippi Medical Center
Lead Sponsor
M
Methodist Rehabilitation Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly. The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.
CONDITIONS
Official Title
Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of spinal cord injury
- More than six months since spinal cord injury diagnosis
- Presence of spasticity in the lower limbs with a severity rating of 3 or higher on the Numerical Rating Scale
- Agreement to reduce antispastic medication if needed
You will not qualify if you...
- Neurological level of spinal cord injury below T11
- Ventilatory dependence
- Change in neurological status in the past 2 months
- Rigidity, contraction, or passive knee joint range of motion less than 40 degrees in both knees
- Botulinum toxin injections in lower extremities within 3 months before enrollment
- Resting systolic blood pressure lower than 90 mm Hg
- Implanted active devices such as intrathecal baclofen pumps
- Passive implants (plates, screws) between T11 and L2 vertebrae
- Skin conditions preventing electrode placement
- Pressure ulcers stage 2 or higher on the gluteal area or lower extremities
- Currently receiving antibiotics for infections
- Pregnancy
- Difficulty following instructions
- Participation in another investigational drug or device study within 30 days before or during this study
- Other medical risks or contraindications as determined by study physicians
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Methodist Rehabilitation Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
2
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
Research Team
M
Matthias J Krenn, Ph.D.
CONTACT
D
Dobrivoje S Stokic, M.D., D.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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