Upper Limb Spasticity Unilaterally in Adults With History of StrokePhase 1/2ASISinULSNCT02074150
ASIS for Botox in Upper Limb Spasticity
A Phase 1/2 study testing Gadolinium, Efficacy of Botox intramuscularly at Week 6 and Efficacy of Botox intramuscularly at Week 12, in people with Upper Limb Spasticity Unilaterally in Adults With History of Stroke and Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors., run by li nguyen at 1 site in United States.
Trial summary
Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Limb Spasticity Unilaterally in Adults With History of Stroke, Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.
- What is being tested?
- Gadolinium, Efficacy of Botox intramuscularly at Week 6 and Efficacy of Botox intramuscularly at Week 12,
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity
- Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale
- Ability to understand and follow verbal directions
- At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS)
- At least 1 functional task score at Day 0 that met the following criteria: nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no.
Who cannot join
- Stroke within 6 months of the study enrollment visit
- Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception
- Previous or current Botox therapy of any type in the study limb
- Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function
- Presence of fixed contracture of the study limb
- Limited use of the wrist and fingers
Trial locations and contacts
1 site in 1 country.
United States1 site
Automatic Subdermal Injector System, Inc
Westminster, California, 92683
Li Nguyen, MD, 714-453-7857, dr.li.nguyen@asis-inc.com
Thanh Phung,, MD, 7148931915, thanhphung@idit-inc.com
About this study
Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.
Read the detailed description
Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Upper limb Spasticity. Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Upper limb Spasticity, and these particular 7 muscle groups. Case in point, patients with Upper limb Spasticity presumably have hyperactivity in these 7 muscle groups, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Upper limb Spasticity patients will not be like those of normal patients, or even the same between these 7 different muscle groups. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, will be specific and valuable indicators to help us modify the Botox dosage and duration to inject into that "unknown" subdermal bloodless space for Aim 2.
Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Upper limb Spasticity, on these particular 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Upper limb Spasticity somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being therapeutic comparison for Botox in Aim 2, in terms of improvement on the Physician Global Assessment Scale and Ashworth score (force required to move an extremity around a joint), at 6,12,18,24, and 30 weeks, and reduction in adverse reactions.
- Conditions
- Upper Limb Spasticity Unilaterally in Adults With History of Stroke, Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.
- Being tested
- Gadolinium, Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12,, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24
- Keywords
- Subdermal bloodless space, Subdermal injection, injectable EMG needle, electrical stimulation, MRI with Gadolinium, Upper Limb Spasticity, intramuscular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
GadoliniumDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.
Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
GadoliniumDrug
Also called Gadolinium Magnevist® (gadopentetate dimeglumine)
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Efficacy of Botox intramuscularly at Week 6Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox intramuscularly at Week 12,Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox intramuscularly at Week 18Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox intramuscularly at Week 24Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox intramuscularly at Week 30Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox subdermally at Week 6Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox subdermally at Week 12Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox subdermally at Week 18Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox subdermally at Week 24Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Efficacy of Botox subdermally at Week 30Drug
Also called Botox (onabotulinumtoxinA)
Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
Adverse Reactions of Botox intramuscularlyDrug
Also called Botox (onabotulinumtoxinA)
Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Adverse Reactions of Botox subdermallyDrug
Also called Botox (onabotulinumtoxinA)
Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Biceps Brachii | Experimental | Biceps Brachii (elbow flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Flexor Carpi Radialis | Experimental | Flexor Carpi Radialis (wrist flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Flexor carpi ulnaris | Experimental | Flexor carpi ulnaris (wrist flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Flexor digitorum profundus | Experimental | Flexor digitorum profundus (finger flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Flexor digitorum sublimis | Experimental | Flexor digitorum sublimis (finger flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Adductor pollicis | Experimental | Adductor pollicis (thumb flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Flexor pollicis longus | Experimental | Flexor pollicis longus (thumb flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. Receives: Drug: Gadolinium |
| Change from Baseline in Elbow Ashworth | Experimental | Change from Baseline in Elbow Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. Ashworth score (the force required to move an extremity around a joint):
0 = No increase in muscle tone (none)
1. = Slight increase
2. = Moderate increase
3. = Considerable increase
4. = Limb rigid (very severe). Receives: Drug: Efficacy of Botox intramuscularly at Week 6; Drug: Efficacy of Botox intramuscularly at Week 12,; Drug: Efficacy of Botox intramuscularly at Week 18; Drug: Efficacy of Botox intramuscularly at Week 24; Drug: Efficacy of Botox intramuscularly at Week 30; Drug: Efficacy of Botox subdermally at Week 6; Drug: Efficacy of Botox subdermally at Week 12; Drug: Efficacy of Botox subdermally at Week 18; Drug: Efficacy of Botox subdermally at Week 24; Drug: Efficacy of Botox subdermally at Week 30 |
| Change from Baseline in Wrist Ashworth | Experimental | Change from Baseline in Wrist Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30.Ashworth score (the force required to move an extremity around a joint):
0 = No increase in muscle tone (none)
1. = Slight increase
2. = Moderate increase
3. = Considerable increase
4. = Limb rigid (very severe). Receives: Drug: Efficacy of Botox intramuscularly at Week 6; Drug: Efficacy of Botox intramuscularly at Week 12,; Drug: Efficacy of Botox intramuscularly at Week 18; Drug: Efficacy of Botox intramuscularly at Week 24; Drug: Efficacy of Botox intramuscularly at Week 30; Drug: Efficacy of Botox subdermally at Week 6; Drug: Efficacy of Botox subdermally at Week 12; Drug: Efficacy of Botox subdermally at Week 18; Drug: Efficacy of Botox subdermally at Week 24; Drug: Efficacy of Botox subdermally at Week 30 |
| Change from Baseline in Finger Ashworth | Experimental | Change from Baseline in Finger Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. Ashworth score (the force required to move an extremity around a joint):
0 = No increase in muscle tone (none)
1. = Slight increase
2. = Moderate increase
3. = Considerable increase
4. = Limb rigid (very severe). Receives: Drug: Efficacy of Botox intramuscularly at Week 6; Drug: Efficacy of Botox intramuscularly at Week 12,; Drug: Efficacy of Botox intramuscularly at Week 18; Drug: Efficacy of Botox intramuscularly at Week 24; Drug: Efficacy of Botox intramuscularly at Week 30; Drug: Efficacy of Botox subdermally at Week 6; Drug: Efficacy of Botox subdermally at Week 12; Drug: Efficacy of Botox subdermally at Week 18; Drug: Efficacy of Botox subdermally at Week 24; Drug: Efficacy of Botox subdermally at Week 30 |
| Change from Baseline in Thumb Ashworth | Experimental | Change from Baseline in Thumb Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. Ashworth score (the force required to move an extremity around a joint):
0 = No increase in muscle tone (none)
1. = Slight increase
2. = Moderate increase
3. = Considerable increase
4. = Limb rigid (very severe). Receives: Drug: Efficacy of Botox intramuscularly at Week 6; Drug: Efficacy of Botox intramuscularly at Week 12,; Drug: Efficacy of Botox intramuscularly at Week 18; Drug: Efficacy of Botox intramuscularly at Week 24; Drug: Efficacy of Botox intramuscularly at Week 30; Drug: Efficacy of Botox subdermally at Week 6; Drug: Efficacy of Botox subdermally at Week 12; Drug: Efficacy of Botox subdermally at Week 18; Drug: Efficacy of Botox subdermally at Week 24; Drug: Efficacy of Botox subdermally at Week 30 |
| Change from Baseline in PGAS | Experimental | Change from Baseline in PGAS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The Physician Global Assessment Scale or PGAS is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from -4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. Receives: Drug: Efficacy of Botox intramuscularly at Week 6; Drug: Efficacy of Botox intramuscularly at Week 12,; Drug: Efficacy of Botox intramuscularly at Week 18; Drug: Efficacy of Botox intramuscularly at Week 24; Drug: Efficacy of Botox intramuscularly at Week 30; Drug: Efficacy of Botox subdermally at Week 6; Drug: Efficacy of Botox subdermally at Week 12; Drug: Efficacy of Botox subdermally at Week 18; Drug: Efficacy of Botox subdermally at Week 24; Drug: Efficacy of Botox subdermally at Week 30 |
| Adverse Reactions with Facial paresis | Experimental | Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30 Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Eyelid ptosis | Experimental | Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Bronchitis | Experimental | Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Neck pain | Experimental | Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Muscle stiffness | Experimental | Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Muscular weakness | Experimental | Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Myalgia | Experimental | Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Muscle pain | Experimental | Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Muscle spasms | Experimental | Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions Injection site pain | Experimental | Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
| Adverse Reactions with Hypertension | Experimental | Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. Receives: Drug: Adverse Reactions of Botox intramuscularly; Drug: Adverse Reactions of Botox subdermally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Gadolinium will be injected with ASIS subdermally (30) or intramuscularly (30) in Upper Limb Spasticity adult patients for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. MRI will be taken promptly after, as starting reference, to which subsequent MRI at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Upper Limb Spasticity, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Upper Limb Spasticity patients will not be same as normal patients, or even between these 7 different muscle groups, but valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2.
Measured: 6 months
Secondary outcomes (1)
Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity.
Efficacy of Botox intramuscularly vs. subdermally with ASIS Device at Week 6,12,18, 24, and 30; in terms of improvement on the Physician Global Assessment Scale (-4=very marked worsening to +4=very marked improvement). Also in terms of improvement, or Median Change from Baseline in Flexor Tone on Ashworth Scale, for Elbow, Wrist, Finger, and Thumb. Ashworth score (the force required to move an extremity around a joint):
0 = No increase in muscle tone (none)
- = Slight increase in muscle tone, giving a 'catch' when the limb was flexed or extended (mild)
- = More marked increase in muscle tone but affected limb is easily flexed (moderate)
- = Considerable increase in muscle tone - passive movement difficult (severe)
- = Limb rigid in flexion or extension (very severe).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Limb Spasticity Unilaterally in Adults With History of StrokeStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- li nguyen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, li nguyen, ASIS Corporation
- Investigators
- Li Nguyen, MD, Principal investigator, AUTOMATIC SUBDERMAL INJECTOR SYSTEM INCThanh Phung,, MD, Principal investigator, AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074150
- Sponsor's protocol ID
- NCTHD081800
- Other IDs
- R44HD081800
- Acronym
- ASISinULS
- Status last verified
- Jun 2015
- First submitted
- 26 Feb 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA. A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629.
PubMed 23515199Knopp MV, Balzer T, Esser M, Kashanian FK, Paul P, Niendorf HP. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol. 2006 Jun;41(6):491-9. doi: 10.1097/01.rli.0000209657.16115.42.
PubMed 16763467Turner-Stokes L, Ward A. Botulinum toxin in the management of spasticity in adults. Clin Med (Lond). 2002 Mar-Apr;2(2):128-30. doi: 10.7861/clinmedicine.2-2-128.
PubMed 11991094Patrick E, Ada L. The Tardieu Scale differentiates contracture from spasticity whereas the Ashworth Scale is confounded by it. Clin Rehabil. 2006 Feb;20(2):173-82. doi: 10.1191/0269215506cr922oa.
PubMed 16541938Jost WH, Hefter H, Reissig A, Kollewe K, Wissel J. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. J Neurol Sci. 2014 Feb 15;337(1-2):86-90. doi: 10.1016/j.jns.2013.11.022. Epub 2013 Nov 22.
PubMed 24361062Baker JA, Pereira G. The efficacy of Botulinum Toxin A for spasticity and pain in adults: a systematic review and meta-analysis using the Grades of Recommendation, Assessment, Development and Evaluation approach. Clin Rehabil. 2013 Dec;27(12):1084-96. doi: 10.1177/0269215513491274. Epub 2013 Jul 17.
PubMed 23864518Ghasemi M, Salari M, Khorvash F, Shaygannejad V. A literature review on the efficacy and safety of botulinum toxin: an injection in post-stroke spasticity. Int J Prev Med. 2013 May;4(Suppl 2):S147-58.
PubMed 23776717
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASIS for Botox in Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT02074150
- Acronym / sponsor ID
- ASISinULS / NCTHD081800
- Conditions
- Upper Limb Spasticity Unilaterally in Adults With History of Stroke, Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.
- Keywords
- Subdermal bloodless space, Subdermal injection, injectable EMG needle, electrical stimulation, MRI with Gadolinium, Upper Limb Spasticity, intramuscular injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- li nguyenIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Botox act on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.
Detailed description
Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult subjects with Upper limb Spasticity. Gadolinium will be injected with ASIS subdermally (30) or conventional intramuscularly (30) for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. An MRI will be taken promptly after Gadolinium injection, as starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it, or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be approximated by the greater or longer Persistent % on MRI. However, this approximation can only work if the variables are minimized to the same population with Upper limb Spasticity, and these particular 7 muscle groups. Case in point, patients with Upper limb Spasticity presumably have hyperactivity in these 7 muscle groups, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values in Upper limb Spasticity patients will not be like those of normal patients, or even the same between these 7 different muscle groups. Therefore, the Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, will be specific and valuable indicators to help us modify the Botox dosage and duration to inject into that "unknown" subdermal bloodless space for Aim 2.
Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Upper limb Spasticity, on these particular 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. Hypothetically speaking, if that subdermal bloodless space in patients with e.g., Upper limb Spasticity somehow failed to show prolongation of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being therapeutic comparison for Botox in Aim 2, in terms of improvement on the Physician Global Assessment Scale and Ashworth score (force required to move an extremity around a joint), at 6,12,18,24, and 30 weeks, and reduction in adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 23
| Arm | Type | Receives |
|---|---|---|
| Biceps Brachii | Experimental | Drug: GadoliniumBiceps Brachii (elbow flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Flexor Carpi Radialis | Experimental | Drug: GadoliniumFlexor Carpi Radialis (wrist flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Flexor carpi ulnaris | Experimental | Drug: GadoliniumFlexor carpi ulnaris (wrist flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Flexor digitorum profundus | Experimental | Drug: GadoliniumFlexor digitorum profundus (finger flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Flexor digitorum sublimis | Experimental | Drug: GadoliniumFlexor digitorum sublimis (finger flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Adductor pollicis | Experimental | Drug: GadoliniumAdductor pollicis (thumb flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Flexor pollicis longus | Experimental | Drug: GadoliniumFlexor pollicis longus (thumb flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients. |
| Change from Baseline in Elbow Ashworth | Experimental | Drug: Efficacy of Botox intramuscularly at Week 6, Drug: Efficacy of Botox intramuscularly at Week 12,, Drug: Efficacy of Botox intramuscularly at Week 18, Drug: Efficacy of Botox intramuscularly at Week 24, Drug: Efficacy of Botox intramuscularly at Week 30, Drug: Efficacy of Botox subdermally at Week 6, Drug: Efficacy of Botox subdermally at Week 12, Drug: Efficacy of Botox subdermally at Week 18, Drug: Efficacy of Botox subdermally at Week 24, Drug: Efficacy of Botox subdermally at Week 30Change from Baseline in Elbow Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. Ashworth score (the force required to move an extremity around a joint): 0 = No increase in muscle tone (none) 1. = Slight increase 2. = Moderate increase 3. = Considerable increase 4. = Limb rigid (very severe). |
| Change from Baseline in Wrist Ashworth | Experimental | Drug: Efficacy of Botox intramuscularly at Week 6, Drug: Efficacy of Botox intramuscularly at Week 12,, Drug: Efficacy of Botox intramuscularly at Week 18, Drug: Efficacy of Botox intramuscularly at Week 24, Drug: Efficacy of Botox intramuscularly at Week 30, Drug: Efficacy of Botox subdermally at Week 6, Drug: Efficacy of Botox subdermally at Week 12, Drug: Efficacy of Botox subdermally at Week 18, Drug: Efficacy of Botox subdermally at Week 24, Drug: Efficacy of Botox subdermally at Week 30Change from Baseline in Wrist Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30.Ashworth score (the force required to move an extremity around a joint): 0 = No increase in muscle tone (none) 1. = Slight increase 2. = Moderate increase 3. = Considerable increase 4. = Limb rigid (very severe). |
| Change from Baseline in Finger Ashworth | Experimental | Drug: Efficacy of Botox intramuscularly at Week 6, Drug: Efficacy of Botox intramuscularly at Week 12,, Drug: Efficacy of Botox intramuscularly at Week 18, Drug: Efficacy of Botox intramuscularly at Week 24, Drug: Efficacy of Botox intramuscularly at Week 30, Drug: Efficacy of Botox subdermally at Week 6, Drug: Efficacy of Botox subdermally at Week 12, Drug: Efficacy of Botox subdermally at Week 18, Drug: Efficacy of Botox subdermally at Week 24, Drug: Efficacy of Botox subdermally at Week 30Change from Baseline in Finger Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. Ashworth score (the force required to move an extremity around a joint): 0 = No increase in muscle tone (none) 1. = Slight increase 2. = Moderate increase 3. = Considerable increase 4. = Limb rigid (very severe). |
| Change from Baseline in Thumb Ashworth | Experimental | Drug: Efficacy of Botox intramuscularly at Week 6, Drug: Efficacy of Botox intramuscularly at Week 12,, Drug: Efficacy of Botox intramuscularly at Week 18, Drug: Efficacy of Botox intramuscularly at Week 24, Drug: Efficacy of Botox intramuscularly at Week 30, Drug: Efficacy of Botox subdermally at Week 6, Drug: Efficacy of Botox subdermally at Week 12, Drug: Efficacy of Botox subdermally at Week 18, Drug: Efficacy of Botox subdermally at Week 24, Drug: Efficacy of Botox subdermally at Week 30Change from Baseline in Thumb Ashworth Scale as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. Ashworth score (the force required to move an extremity around a joint): 0 = No increase in muscle tone (none) 1. = Slight increase 2. = Moderate increase 3. = Considerable increase 4. = Limb rigid (very severe). |
| Change from Baseline in PGAS | Experimental | Drug: Efficacy of Botox intramuscularly at Week 6, Drug: Efficacy of Botox intramuscularly at Week 12,, Drug: Efficacy of Botox intramuscularly at Week 18, Drug: Efficacy of Botox intramuscularly at Week 24, Drug: Efficacy of Botox intramuscularly at Week 30, Drug: Efficacy of Botox subdermally at Week 6, Drug: Efficacy of Botox subdermally at Week 12, Drug: Efficacy of Botox subdermally at Week 18, Drug: Efficacy of Botox subdermally at Week 24, Drug: Efficacy of Botox subdermally at Week 30Change from Baseline in PGAS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The Physician Global Assessment Scale or PGAS is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from -4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. |
| Adverse Reactions with Facial paresis | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyFacial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30 |
| Adverse Reactions with Eyelid ptosis | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyEyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Bronchitis | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyBronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Neck pain | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyNeck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Muscle stiffness | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyMusculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Muscular weakness | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyMuscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Myalgia | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyMyalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Muscle pain | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyMusculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Muscle spasms | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyMuscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions Injection site pain | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyInjection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
| Adverse Reactions with Hypertension | Experimental | Drug: Adverse Reactions of Botox intramuscularly, Drug: Adverse Reactions of Botox subdermallyHypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity
- Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale
- Ability to understand and follow verbal directions
- At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS)
- At least 1 functional task score at Day 0 that met the following criteria: nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no.
Key exclusion criteria (6 listed)
- Stroke within 6 months of the study enrollment visit
- Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception
- Previous or current Botox therapy of any type in the study limb
- Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function
- Presence of fixed contracture of the study limb
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 |
|---|---|---|
| GadoliniumAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs. | Drug | Adductor pollicis, Biceps Brachii, Flexor Carpi Radialis, Flexor carpi ulnaris, Flexor digitorum profundus, Flexor digitorum sublimis, Flexor pollicis longus |
| GadoliniumAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. | Drug | Adductor pollicis, Biceps Brachii, Flexor Carpi Radialis, Flexor carpi ulnaris, Flexor digitorum profundus, Flexor digitorum sublimis, Flexor pollicis longus |
| GadoliniumAlso: Gadolinium Magnevist® (gadopentetate dimeglumine)Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI. | Drug | Adductor pollicis, Biceps Brachii, Flexor Carpi Radialis, Flexor carpi ulnaris, Flexor digitorum profundus, Flexor digitorum sublimis, Flexor pollicis longus |
| Efficacy of Botox intramuscularly at Week 6Also: Botox (onabotulinumtoxinA)Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox intramuscularly at Week 12,Also: Botox (onabotulinumtoxinA)Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox intramuscularly at Week 18Also: Botox (onabotulinumtoxinA)Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox intramuscularly at Week 24Also: Botox (onabotulinumtoxinA)Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox intramuscularly at Week 30Also: Botox (onabotulinumtoxinA)Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox subdermally at Week 6Also: Botox (onabotulinumtoxinA)Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox subdermally at Week 12Also: Botox (onabotulinumtoxinA)Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox subdermally at Week 18Also: Botox (onabotulinumtoxinA)Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox subdermally at Week 24Also: Botox (onabotulinumtoxinA)Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Efficacy of Botox subdermally at Week 30Also: Botox (onabotulinumtoxinA)Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth. | Drug | Change from Baseline in Elbow Ashworth, Change from Baseline in Finger Ashworth, Change from Baseline in PGAS, Change from Baseline in Thumb Ashworth, Change from Baseline in Wrist Ashworth |
| Adverse Reactions of Botox intramuscularlyAlso: Botox (onabotulinumtoxinA)Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension. | Drug | Adverse Reactions Injection site pain, Adverse Reactions with Bronchitis, Adverse Reactions with Eyelid ptosis, Adverse Reactions with Facial paresis, Adverse Reactions with Hypertension, Adverse Reactions with Muscle pain, Adverse Reactions with Muscle spasms, Adverse Reactions with Muscle stiffness, Adverse Reactions with Muscular weakness, Adverse Reactions with Myalgia, Adverse Reactions with Neck pain |
| Adverse Reactions of Botox subdermallyAlso: Botox (onabotulinumtoxinA)Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension. | Drug | Adverse Reactions Injection site pain, Adverse Reactions with Bronchitis, Adverse Reactions with Eyelid ptosis, Adverse Reactions with Facial paresis, Adverse Reactions with Hypertension, Adverse Reactions with Muscle pain, Adverse Reactions with Muscle spasms, Adverse Reactions with Muscle stiffness, Adverse Reactions with Muscular weakness, Adverse Reactions with Myalgia, Adverse Reactions with Neck pain |
Primary outcome
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Time frame: 6 months
Gadolinium will be injected with ASIS subdermally (30) or intramuscularly (30) in Upper Limb Spasticity adult patients for these 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor Pollicis, and Flexor Pollicis Longus. MRI will be taken promptly after, as starting reference, to which subsequent MRI at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Upper Limb Spasticity, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Upper Limb Spasticity patients will not be same as normal patients, or even between these 7 different muscle groups, but valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2.
1 secondary outcome
Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 23515199Lorenc ZP, Kenkel JM, Fagien S, Hirmand H, Nestor MS, Sclafani AP, Sykes JM, Waldorf HA. A review of onabotulinumtoxinA (Botox). Aesthet Surg J. 2013 Mar;33(1 Suppl):9S-12S. doi: 10.1177/1090820X12474629.
- Background: PubMed 16763467Knopp MV, Balzer T, Esser M, Kashanian FK, Paul P, Niendorf HP. Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Invest Radiol. 2006 Jun;41(6):491-9. doi: 10.1097/01.rli.0000209657.16115.42.
- Background: PubMed 11991094Turner-Stokes L, Ward A. Botulinum toxin in the management of spasticity in adults. Clin Med (Lond). 2002 Mar-Apr;2(2):128-30. doi: 10.7861/clinmedicine.2-2-128.
- Background: PubMed 16541938Patrick E, Ada L. The Tardieu Scale differentiates contracture from spasticity whereas the Ashworth Scale is confounded by it. Clin Rehabil. 2006 Feb;20(2):173-82. doi: 10.1191/0269215506cr922oa.
- Background: PubMed 24361062Jost WH, Hefter H, Reissig A, Kollewe K, Wissel J. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. J Neurol Sci. 2014 Feb 15;337(1-2):86-90. doi: 10.1016/j.jns.2013.11.022. Epub 2013 Nov 22.
- Background: PubMed 23864518Baker JA, Pereira G. The efficacy of Botulinum Toxin A for spasticity and pain in adults: a systematic review and meta-analysis using the Grades of Recommendation, Assessment, Development and Evaluation approach. Clin Rehabil. 2013 Dec;27(12):1084-96. doi: 10.1177/0269215513491274. Epub 2013 Jul 17.
- Background: PubMed 23776717Ghasemi M, Salari M, Khorvash F, Shaygannejad V. A literature review on the efficacy and safety of botulinum toxin: an injection in post-stroke spasticity. Int J Prev Med. 2013 May;4(Suppl 2):S147-58.
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.
Li Nguyen, MD principal investigator
AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Thanh Phung,, MD principal investigator
AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gadolinium, Efficacy of Botox intramuscularly at Week 6 and Efficacy of Botox intramuscularly at Week 12, in people with Upper Limb Spasticity Unilaterally in Adults With History of Stroke and Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors., run by li nguyen 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 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Nguyen, MD ((714)-453-7857, dr.li.nguyen@asis-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Prolongation Ability Score for Gadolinium subdermally injected. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074150, which also lists 7 linked publications.
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 24 Jun 2015; AzTrials last refreshed its copy on 28 Oct 2026.