Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings

• Status: Completed
• Trial end date: 2019-11-18
• Target enrollment: 0
• Participant gender: All

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 method is called three dimensional innervation zone imaging, or 3DIZI.

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

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: University of Houston
• Treatments: Botulinum Toxins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.