Status:
TERMINATED
The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Allergan
Conditions:
Stroke
Muscle Spasticity
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is...
Detailed Description
The research questions for the present study series are as followed: 1. How does the movement and morphology of BT muscle effect (BTME) differ between standardized, research injections into spastic a...
Eligibility Criteria
Inclusion
- Experimental Group:
- Male and female aged 30-75
- Diagnosis of any stroke (ischemic or hemorrhagic, first occurrence or recurrent)
- Clinically significant lower extremity spasticity as assessed by PI that would benefit from BT treatment
- Ambulatory with or without device and without assistance at household or greater level
- Indication to inject gastrocnemius muscle (any combination of spastic lower extremity muscle injections are acceptable)
- Goal of treatment may include improvement of gait, ankle range of motion, ankle foot orthosis fit, heel strike, ankle position in stance phase, decreased clonus, or relief from painful muscle spasms
- Naïve to BT of any serotype in any lower extremity muscle
- Naïve to phenol or alcohol treatment in any lower extremity muscle
Exclusion
- History of concomitant neurological disease (central or peripheral) other than stroke
- Contraindication to intramuscular injection of BT
- Medically unstable as determined by PI
- Have an intrathecal baclofen pump
- Contraindication for MRI (Subjects with MRI-compatible hip replacements may participate, but not those with total knee replacements due to artifact)
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03367429
Start Date
June 15 2018
End Date
September 18 2019
Last Update
December 29 2021
Active Locations (1)
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1
NewYork Presbyterian Hospital - Weill Cornell Medicine
New York, New York, United States, 10065