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

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ClinicalTrials.gov Identifier: NCT03302741
Recruitment Status : Recruiting
First Posted : October 5, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
University of Houston
Information provided by (Responsible Party):
Sheng Li, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Spasticity Drug: Botulinum neurotoxin (BTX) Other: Physical Therapy Device: Standard BTX injection (ultrasound guided) Device: 3-dimensional innervation zone (3DIZ) guided injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard BTX injection (ultrasound guided)
For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the IZs of the entire muscle.
Drug: Botulinum neurotoxin (BTX)
Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.
Other Name: Botox

Other: Physical Therapy
Standard physical therapy will be ordered to both groups as part of standard of care for patients after BTX injections to maximize the outcomes.

Device: Standard BTX injection (ultrasound guided)
For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the innervation zones (IZs) of the entire muscle.

Experimental: 3-dimensional innervation zone (3DIZ) guided injection
In the IZ-guided injection technique, IZ location obtained using the 3DIZ will be first marked over the skin surface of the muscle and the depth of the IZ will be also provided. The 3DIZ will be applied to the IZ-guided injection group 1 day prior to scheduled injection. The surface location and depth information of the IZ will be used to guide where the needle tip needs to go. Currently, patients commonly receive 1 to 2 injection sites, occasionally 3 sites for biceps muscles. To standardize the procedure, we will choose 2 sites for all patients.
Drug: Botulinum neurotoxin (BTX)
Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.
Other Name: Botox

Other: Physical Therapy
Standard physical therapy will be ordered to both groups as part of standard of care for patients after BTX injections to maximize the outcomes.

Device: 3-dimensional innervation zone (3DIZ) guided injection
Simultaneous surface EMG and intramuscular EMG measurements will be acquired from the spastic biceps of the patients. Patients will be seated comfortably on a height-adjustable chair. The arm to be tested will be secured firmly on a customized apparatus with the elbow joint at approximately 90° of flexion and the shoulder at approximately 45° of abduction and 30° of flexion. The 128-channel unipolar surface EMG signals will be recorded with 2 flexible 2-dimensional 64-channel surface electrode array. A coating fine wire electrode will be inserted into the mid-axial section of the biceps to record bipolar intramuscular EMG signals. Ultrasound scan will be performed on the biceps to identify the location of the inserted wire electrode. Patients will be asked to contract their impaired biceps to perform maximum voluntary contraction of elbow flexion against the vertical plates 3 times.




Primary Outcome Measures :
  1. Spasticity as assessed by reflex torque of elbow flexors [ Time Frame: baseline (1 day prior to BTX injection) ]
    Each subject will receive a total of 60 degrees of computer-controlled elbow extension stretching at different speeds. The stretch ends at 10 degrees beyond the resting angle of the elbow joint during standing to offset the baseline difference among subjects. From the angle-torque relations, reflex torque is obtained after subtracting passive torque at 5˚/sec from those at 50˚/sec or 100˚/sec. Reflex torque is considered to reflect the neural component of muscle spasticity.

  2. Spasticity as assessed by reflex torque of elbow flexors [ Time Frame: 3 weeks after BTX injection ]
    Each subject will receive a total of 60 degrees of computer-controlled elbow extension stretching at different speeds. The stretch ends at 10 degrees beyond the resting angle of the elbow joint during standing to offset the baseline difference among subjects. From the angle-torque relations, reflex torque is obtained after subtracting passive torque at 5˚/sec from those at 50˚/sec or 100˚/sec. Reflex torque is considered to reflect the neural component of muscle spasticity.

  3. Spasticity as assessed by reflex torque of elbow flexors [ Time Frame: 3 months after BTX injection ]
    Each subject will receive a total of 60 degrees of computer-controlled elbow extension stretching at different speeds. The stretch ends at 10 degrees beyond the resting angle of the elbow joint during standing to offset the baseline difference among subjects. From the angle-torque relations, reflex torque is obtained after subtracting passive torque at 5˚/sec from those at 50˚/sec or 100˚/sec. Reflex torque is considered to reflect the neural component of muscle spasticity.


Secondary Outcome Measures :
  1. Spasticity as assessed by the Modified Ashworth Scale (MAS) [ Time Frame: baseline (1 day prior to BTX injection) ]

    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.


  2. Spasticity as assessed by the Modified Ashworth Scale (MAS) [ Time Frame: 3 weeks after BTX injection ]

    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.


  3. Spasticity as assessed by the Modified Ashworth Scale (MAS) [ Time Frame: 3 months after BTX injection ]

    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.




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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302741


Contacts
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Contact: Sheng Li, MD, PhD (713) 797-7125 Sheng.Li@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 70030
Contact: Sheng Li, MD, PhD    713-797-7125    Sheng.Li@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Houston
Investigators
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Principal Investigator: Sheng Li, MD, PhD The University of Texas Health Science Center, Houston

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Responsible Party: Sheng Li, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03302741     History of Changes
Other Study ID Numbers: HSC-MS-17-0174
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sheng Li, The University of Texas Health Science Center, Houston:
stroke