Trial Outcomes & Findings for Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings (NCT NCT03302741)
NCT ID: NCT03302741
Last Updated: 2020-11-05
Results Overview
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.
COMPLETED
PHASE4
17 participants
baseline (1 day prior to BTX injection)
2020-11-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings
Baseline characteristics by cohort
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
55.43 years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
52.75 years
STANDARD_DEVIATION 11.90 • n=7 Participants
|
54.00 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (1 day prior to BTX injection)Population: Data for 1 in each arm was not analyzed because these participants only completed one out of three sessions.
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.
Outcome measures
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
|---|---|---|
|
Spasticity as Assessed by Reflex Torque of Elbow Flexors
reflex torque at 50˚/sec
|
2.32 Newton meter (n-m)
Standard Deviation 1.73
|
2.04 Newton meter (n-m)
Standard Deviation 1.19
|
|
Spasticity as Assessed by Reflex Torque of Elbow Flexors
reflex torque 100˚/sec
|
2.41 Newton meter (n-m)
Standard Deviation 2.35
|
3.11 Newton meter (n-m)
Standard Deviation 1.67
|
PRIMARY outcome
Timeframe: 3 weeks after BTX injectionPopulation: Data for 1 in each arm was not analyzed because these participants only completed one out of three sessions.
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.
Outcome measures
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
|---|---|---|
|
Spasticity as Assessed by Reflex Torque of Elbow Flexors
reflex torque at 50˚/sec
|
2.22 Newton meter (n-m)
Standard Deviation 1.21
|
1.47 Newton meter (n-m)
Standard Deviation 0.63
|
|
Spasticity as Assessed by Reflex Torque of Elbow Flexors
reflex torque at 100˚/sec
|
2.64 Newton meter (n-m)
Standard Deviation 1.69
|
2.14 Newton meter (n-m)
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: 3 months after BTX injectionPopulation: Data for 1 in each arm was not analyzed because these participants only completed one out of three sessions.
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.
Outcome measures
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
|---|---|---|
|
Spasticity as Assessed by Reflex Torque of Elbow Flexors
reflex torque at 50˚/sec
|
2.71 Newton meter (n-m)
Standard Deviation 2.12
|
1.89 Newton meter (n-m)
Standard Deviation 0.75
|
|
Spasticity as Assessed by Reflex Torque of Elbow Flexors
reflex torque at 100˚/sec
|
3.29 Newton meter (n-m)
Standard Deviation 2.57
|
2.85 Newton meter (n-m)
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: baseline (1 day prior to BTX injection)Population: Data for 1 in each arm was not analyzed because these participants only completed one out of three sessions.
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.
Outcome measures
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
|---|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
0
|
0 Participants
|
0 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
1
|
0 Participants
|
0 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
1+
|
0 Participants
|
0 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
2
|
7 Participants
|
6 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
3
|
0 Participants
|
2 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 weeks after BTX injectionPopulation: Data for 1 in each arm was not analyzed because these participants only completed one out of three sessions.
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.
Outcome measures
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
|---|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
0
|
0 Participants
|
0 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
1
|
0 Participants
|
1 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
1+
|
4 Participants
|
4 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
2
|
3 Participants
|
2 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
3
|
0 Participants
|
1 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months after BTX injectionPopulation: Data for 1 in each arm was not analyzed because these participants only completed one out of three sessions.
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.
Outcome measures
| Measure |
Standard BTX Injection (Ultrasound Guided)
n=7 Participants
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.
|
3-dimensional Innervation Zone (3DIZ) Guided Injection
n=8 Participants
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.
|
|---|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
0
|
0 Participants
|
0 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
1
|
0 Participants
|
0 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
1+
|
2 Participants
|
2 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
2
|
5 Participants
|
5 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
3
|
0 Participants
|
1 Participants
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
4
|
0 Participants
|
0 Participants
|
Adverse Events
Standard BTX Injection (Ultrasound Guided)
3-dimensional Innervation Zone (3DIZ) Guided Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sheng Li, MD, PhD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place