The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination

• Status: Terminated
• Trial end date: 2019-09-18
• Target enrollment: 0
• Participant gender: All

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 limited. The wide-spread use of BT in spasticity management, expense of these agents, and detrimental impact from movement into non-injected muscles mandates a better understanding of BT movement within muscles. A proof-of-concept paper written by investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with "voxel thresholds" that was able to detect intramuscular effects of BT at 2 and 3 months post-injection of BT. The purpose of the current set of studies is to refine this MRI technique to better visualize the movement of botulinum toxin through muscle. In addition, the investigators plan to explore, using the imaging technique, how spastic muscle and differing dilutions affect BT movement in an effort to support the development of better research techniques to study toxin movement in human muscle.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Allergan

Criteria

Experimental Group:

Inclusion Criteria:

• 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 Criteria:

• 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)