Peripheral Modulation of Muscle Stiffness and Spasticity
Status: | Not yet recruiting |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/11/2019 |
Start Date: | June 2019 |
End Date: | December 2020 |
Contact: | Olanta Chandler |
Email: | olanta.chandler@nyumc.org |
Phone: | 212 263 8044 |
Double blind, randomized, placebo-controlled trial of human recombinant hyaluronidase
injections in individuals with post-stroke upper limb muscle stiffness. Fifty individuals
with post-stroke hemiparesis, with moderately-severe muscle stiffness, between 6 months and 3
years will be randomized to receive either hyaluronidase plus saline (treatment arm, n=25) or
normal saline (control arm, n=25) injections. Both the assessors and the patients will be
blind to group assignment. All patients will be assessed at three time points: (1)
pre-injection, (2) 1-2 weeks post-injection, and (3) 12-14 weeks post-injection. Assessments
will be performed pre-injection and 1-2 weeks post-injection for joint range of motion,
muscle strength by EMG MVC, upper limb motor impairment and function, stretch reflex testing,
shear wave elastography, and muscle MRI, and 12-14 weeks post-injection for all assessments
except muscle MRI
injections in individuals with post-stroke upper limb muscle stiffness. Fifty individuals
with post-stroke hemiparesis, with moderately-severe muscle stiffness, between 6 months and 3
years will be randomized to receive either hyaluronidase plus saline (treatment arm, n=25) or
normal saline (control arm, n=25) injections. Both the assessors and the patients will be
blind to group assignment. All patients will be assessed at three time points: (1)
pre-injection, (2) 1-2 weeks post-injection, and (3) 12-14 weeks post-injection. Assessments
will be performed pre-injection and 1-2 weeks post-injection for joint range of motion,
muscle strength by EMG MVC, upper limb motor impairment and function, stretch reflex testing,
shear wave elastography, and muscle MRI, and 12-14 weeks post-injection for all assessments
except muscle MRI
Aim 1: To test the effect of hyaluronidase injections on upper limb motor outcomes; Aim 2: To
evaluate the effect of hyaluronidase injections on non-neural and neural components of muscle
stiffness; Aim 3. To determine the effect of hyaluronidase on intramuscular GAG content by
proton T1p relaxation mapping on muscle MRI.
evaluate the effect of hyaluronidase injections on non-neural and neural components of muscle
stiffness; Aim 3. To determine the effect of hyaluronidase on intramuscular GAG content by
proton T1p relaxation mapping on muscle MRI.
Inclusion Criteria:
- ischemic or hemorrhagic stroke 6-36 months prior and radiologically verified;
- moderately-severe muscle stiffness, score of 2-3 on the Modified Ashworth Scale;
- lack of full passive and active range of motion in at least 2/4 areas (shoulder,
elbow, forearm, wrist) in the hemiparetic upper limb;
- willingness to have MRI, complete all clinical assessments, and comply with study
protocols;
- ability to give informed consent and HIPPA certifications; and
- Ability to communicate in English.
Exclusion Criteria:
- treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past
three months;
- other neurologic condition that may affect motor response (e.g., Parkinson's disease,
ALS, MS);
- clinically significant cognitive dysfunction with score <24 on Folstein's Mini Mental
Status Examination or depression with score <10 on the PHQ-9;
- pregnancy;
- known hypersensitivity to hyaluronidase;
- claustrophobia;
- presence of pacemakers and clips that preclude MRI;
- contracture at any joint with Modified Ashworth Scale score = 4 and major disability
with modified Rankin Scale score ≥4; and
- History of psychiatric illness, complicated medical condition, or significant injury
to either upper limb.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Preeti Raghavan, MD
Phone: 212-263-8044
New York University School of Medicine NYU School of Medicine has a proud history that...
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