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

NCT ID: NCT03302741

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2019-11-18

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.

Conditions

Spasticity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Botulinum neurotoxin (BTX)

Intervention Type: DRUG

Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.

Physical Therapy

Intervention Type: OTHER

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

Standard BTX injection (ultrasound guided)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Botulinum neurotoxin (BTX)

Intervention Type: DRUG

Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.

Physical Therapy

Intervention Type: OTHER

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

3-dimensional innervation zone (3DIZ) guided injection

Intervention Type: DEVICE

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.

Interventions

Botulinum neurotoxin (BTX)

Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Botox

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Houston

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Sheng Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheng Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-17-0174

Identifier Type: -

Identifier Source: org_study_id