SpasticityPhase 4NCT03302741
Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings
A Phase 4 study testing Botulinum neurotoxin (BTX), Physical Therapy and Standard BTX injection (ultrasound guided) in people with Spasticity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Spasticity
- What is being tested?
- Botulinum neurotoxin (BTX), Physical Therapy and Standard BTX injection (ultrasound guided)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2017to 18 Nov 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 70030
About this study
Official title: Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface
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
- Being tested
- Botulinum neurotoxin (BTX), Physical Therapy, Standard BTX injection (ultrasound guided), 3-dimensional innervation zone (3DIZ) guided injection
- Keywords
- stroke
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum neurotoxin (BTX)Drug
Also called Botox
Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.
Physical TherapyOther
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)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 injectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard BTX injection (ultrasound guided) | Active comparator | 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. Receives: Drug: Botulinum neurotoxin (BTX); Other: Physical Therapy; Device: Standard BTX injection (ultrasound guided) |
| 3-dimensional innervation zone (3DIZ) guided injection | Experimental | 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. Receives: Drug: Botulinum neurotoxin (BTX); Other: Physical Therapy; Device: 3-dimensional innervation zone (3DIZ) guided injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity as Assessed by Reflex Torque of Elbow Flexors
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.
Measured: baseline (1 day prior to BTX injection)
Spasticity as Assessed by Reflex Torque of Elbow Flexors
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.
Measured: 3 weeks after BTX injection
Spasticity as Assessed by Reflex Torque of Elbow Flexors
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.
Measured: 3 months after BTX injection
Secondary outcomes (3)
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
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.
Measured: baseline (1 day prior to BTX injection)
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
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.
Measured: 3 weeks after BTX injection
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
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.
Measured: 3 months after BTX injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start21 Nov 2017
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302741
- Sponsor's protocol ID
- HSC-MS-17-0174
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2017
- Last updated
- 5 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface
- ClinicalTrials.gov ID
- NCT03302741
- Acronym / sponsor ID
- HSC-MS-17-0174
- Conditions
- Spasticity
- Keywords
- stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- University of Houston
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 5 Oct 2017 (actual)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard BTX injection (ultrasound guided) | Active comparator | Drug: Botulinum neurotoxin (BTX), Other: Physical Therapy, 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 IZs of the entire muscle. |
| 3-dimensional innervation zone (3DIZ) guided injection | Experimental | Drug: Botulinum neurotoxin (BTX), Other: Physical Therapy, Device: 3-dimensional innervation zone (3DIZ) guided injectionIn 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum neurotoxin (BTX)Also: BotoxEach patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site. | Drug | 3-dimensional innervation zone (3DIZ) guided injection, Standard BTX injection (ultrasound guided) |
| Physical TherapyStandard physical therapy will be ordered to both groups as part of standard of care for patients after BTX injections to maximize the outcomes. | Other | 3-dimensional innervation zone (3DIZ) guided injection, Standard BTX injection (ultrasound guided) |
| 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. | Device | Standard BTX injection (ultrasound guided) |
| 3-dimensional innervation zone (3DIZ) guided injectionSimultaneous 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. | Device | 3-dimensional innervation zone (3DIZ) guided injection |
Primary outcome
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.
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.
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.
3 secondary outcomes
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: baseline (1 day prior to BTX injection)
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: 3 weeks after BTX injection
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time frame: 3 months after BTX injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng Li, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum neurotoxin (BTX), Physical Therapy and Standard BTX injection (ultrasound guided) in people with Spasticity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity as Assessed by Reflex Torque of Elbow Flexors (time frame: baseline (1 day prior to BTX injection)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.