Status:
COMPLETED
Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
University of Houston
Conditions:
Spasticity
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate if it is possible to use a new 3D imaging method to guide Botulinum neurotoxin (BTX) injection for muscle spasticity management after stroke. This imaging meth...
Eligibility Criteria
Inclusion
- a history of not more than one stroke which occurred at least 6 months prior to study enrollment;
- elbow flexor spasticity rated at 2 or 3 on Modified Ashworth scale (MAS);
- receiving repeated botulinum toxin injection every 3-4 months;
- absence of excessive pain in the paretic upper limb;
- capacity to provide informed consent, with Mini-Mental State Examination (MMSE) must be 25 or higher;
- The following modified Ashworth scale (MAS) will be used for spasticity assessment:
- 0 -No increase in muscle tone; 1 -Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ -Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 -More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3 -Considerable increase in muscle tone, passive movement difficult; 4 -Affected part(s) rigid in flexion or extension.
Exclusion
- recent botulinum toxin injection \< 4 months;
- recent changes in antispastic medications \<3 weeks (i.e., the antispastic medication regime is not stable;
- Changes in antispastic medications (such as baclofen, tizanidine, dantrolene etc) during the followup research visits. (NOTE: it is clinically rare for patients who receive repeated injections to change their antispastic medications);
- history of spinal cord injury or traumatic brain damage;
- history of serious medical illness such as cardiovascular or pulmonary complications;
- any condition that, in the judgment of a physician, would prevent the person from participating.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03302741
Start Date
November 21 2017
End Date
November 18 2019
Last Update
November 5 2020
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 70030