Clinical trial NCT03302741: Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings
Official title: Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spasticity
Keywords: stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Houston
First posted: 2017-10-05
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Spasticity as Assessed by Reflex Torque of Elbow Flexors
timeFrame: baseline (1 day prior to BTX injection)
measure: Spasticity as Assessed by Reflex Torque of Elbow Flexors
timeFrame: 3 weeks after BTX injection
measure: Spasticity as Assessed by Reflex Torque of Elbow Flexors
timeFrame: 3 months after BTX injection
Secondary outcomes:
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: baseline (1 day prior to BTX injection)
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: 3 weeks after BTX injection
measure: Spasticity as Assessed by the Modified Ashworth Scale (MAS)
timeFrame: 3 months after BTX injection
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: