A Phase 4 interventional study of Botulinum neurotoxin (BTX) and Physical Therapy in Spasticity, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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Among 165 studies in Muscle Spasticity with a site in United States — 34 open to participants now, 44 under way, none of them phase 3. Muscle Spasticity · United States.
Among the 165 studies in Muscle Spasticity with a site in United States, this one is the 98th largest by enrollment of the 130 interventional ones that give a count, is one of 3 that started in 2017, is one of 9 in phase 4, and was the 92nd registered.
622 studies on the registry are indexed under Muscle Spasticity; 128 are open to participants now.
Browse Muscle Spasticity studies →34 of the 165 studies in Muscle Spasticity with a site in United States are open now. Recruiting first, the newest first:
Kessler Foundation · Sites in United States
Ages 22+
Kessler Foundation · Sites in United States
Ages 18+
Alberto Esquenazi · Sites in United States
Ages 18–80
Martin Piazza · Sites in United States
Ages 3–14
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 88 Muscle Spasticity studies recruiting now, 29 (33%) set no upper age limit and 47 (53%) stop at 75 or younger; 34 take children under 18; 11 take healthy volunteers.
This study: 21 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
165 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 29 · Phase 3 25 · Phase 4 9
First in 1997; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 36 across 473 interventional studies indexed under Muscle Spasticity.
Median enrollment 31 across the 130 interventional studies, 55 across the 34 observational. Of the 108 that completed or were terminated, 44 (41%) have results posted.
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49 of 165 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 899 studies on the registry; 214 are open to participants now.
Of its 174 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
The University of Texas Health Science Center, Houston has 3 studies filed under Muscle Spasticity — fewer than ten, so there is no comparison to draw.
17 of the studies in Muscle Spasticity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07516067Martin PiazzaSpinal Cord Stimulation for Children With Cerebral Palsy | 2026-11 |
| NCT07792616University of Mississippi Medical CenterElectrical Neuromodulation for Modifying Spinal Network Involved in Spasticity | 2026-12-31 |
| NCT05094362Medical University of South CarolinaOperant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning | 2026-12-31 |
| NCT06070233Ohio State UniversityRadiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy | 2026-12-31 |
| NCT06341023University of Illinois at ChicagoFunctional Balance Intervention in Multiple Sclerosis | 2027-01-09 |
Add all 17 to your calendar (.ics) → With an account.
Among the 165 studies in Muscle Spasticity with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Other: Physical Therapy · Device: Standard BTX injection (ultrasound guided)
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) · Other: Physical Therapy · Device: 3-dimensional innervation zone (3DIZ) guided injection
Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.
Also known as: Botox
Standard physical therapy will be ordered to both groups as part of standard of care for patients after BTX injections to maximize the outcomes.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months after BTX injection
| Milestone | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| Started | 8 | 9 |
| Completed | 7 | 8 |
| Not completed | 1 | 1 |
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.
| Newton meter (n-m) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| reflex torque at 50˚/sec | 2.32 ± 1.73 | 2.04 ± 1.19 |
| reflex torque 100˚/sec | 2.41 ± 2.35 | 3.11 ± 1.67 |
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.
| Newton meter (n-m) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| reflex torque at 50˚/sec | 2.22 ± 1.21 | 1.47 ± 0.63 |
| reflex torque at 100˚/sec | 2.64 ± 1.69 | 2.14 ± 1.20 |
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.
| Newton meter (n-m) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| reflex torque at 50˚/sec | 2.71 ± 2.12 | 1.89 ± 0.75 |
| reflex torque at 100˚/sec | 3.29 ± 2.57 | 2.85 ± 1.23 |
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.
| Participants | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| 0 | 0 | 0 |
| 1 | 0 | 0 |
| 1+ | 0 | 0 |
| 2 | 7 | 6 |
| 3 | 0 | 2 |
| 4 | 0 | 0 |
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.
| Participants | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| 0 | 0 | 0 |
| 1 | 0 | 1 |
| 1+ | 4 | 4 |
| 2 | 3 | 2 |
| 3 | 0 | 1 |
| 4 | 0 | 0 |
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.
| Participants | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection |
|---|---|---|
| 0 | 0 | 0 |
| 1 | 0 | 0 |
| 1+ | 2 | 2 |
| 2 | 5 | 5 |
| 3 | 0 | 1 |
| 4 | 0 | 0 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard BTX Injection (Ultrasound Guided) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| 3-dimensional Innervation Zone (3DIZ) Guided Injection | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 2 | 3 | 5 |
| Age, Continuous(years) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection | Total |
|---|---|---|---|
| Mean | 55.43 ± 11.91 | 52.75 ± 11.90 | 54.00 ± 11.56 |
| Sex: Female, Male(Participants) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 4 | 5 | 9 |
| Race/Ethnicity, Customized(Participants) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection | Total |
|---|---|---|---|
| White | 1 | 0 | 1 |
| Black | 4 | 2 | 6 |
| Hispanic | 1 | 3 | 4 |
| Asian | 1 | 2 | 3 |
| Other | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Standard BTX Injection (Ultrasound Guided) | 3-dimensional Innervation Zone (3DIZ) Guided Injection | Total |
|---|---|---|---|
| United States | 7 | 8 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Nov 2019, 23 months.
Results were first posted in Nov 2020, 11 months after primary completion.
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The University of Texas Health Science Center, Houston →