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

Last updated: October 13, 2020
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Completed

Phase

4

Condition

Sjögren-larsson Syndrome

Limb Spasticity

Dystonia

Treatment

N/A

Clinical Study ID

NCT03302741
HSC-MS-17-0174
  • Ages 21-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • a history of not more than one stroke which occurred at least 6 months prior to studyenrollment;
  • 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) mustbe 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 andrelease or by minimal resistance at the end of the range of motion when the affectedpart(s) is moved in flexion or extension; 1+ -Slight increase in muscle tone, manifested bya catch, followed by minimal resistance throughout the remainder (less than half) of theROM; 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

Exclusion Criteria:

  • recent botulinum toxin injection < 4 months;
  • recent changes in antispastic medications <3 weeks (i.e., the antispastic medicationregime 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 whoreceive 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 fromparticipating.

Study Design

Total Participants: 17
Study Start date:
November 21, 2017
Estimated Completion Date:
November 18, 2019

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 70030
    United States

    Site Not Available

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