Back to resultsASIS for Botox in Upper Limb Spasticity (ASISinULS)
Primary Purpose
Upper Limb Spasticity Unilaterally in Adults With History of Stroke, Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gadolinium
Gadolinium
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
Efficacy of Botox intramuscularly at Week 30
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
Efficacy of Botox subdermally at Week 30
Adverse Reactions of Botox intramuscularly
Adverse Reactions of Botox subdermally
Sponsored by
About this trial
This is an interventional treatment trial for Upper Limb Spasticity Unilaterally in Adults With History of Stroke focused on measuring Subdermal bloodless space, Subdermal injection, injectable EMG needle, electrical stimulation, MRI with Gadolinium, Upper Limb Spasticity, intramuscular injection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Automatic Subdermal Injector System, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Biceps Brachii
Flexor Carpi Radialis
Flexor carpi ulnaris
Flexor digitorum profundus
Flexor digitorum sublimis
Adductor pollicis
Flexor pollicis longus
Change from Baseline in Elbow Ashworth
Change from Baseline in Wrist Ashworth
Change from Baseline in Finger Ashworth
Change from Baseline in Thumb Ashworth
Change from Baseline in PGAS
Adverse Reactions with Facial paresis
Adverse Reactions with Eyelid ptosis
Adverse Reactions with Bronchitis
Adverse Reactions with Neck pain
Adverse Reactions with Muscle stiffness
Adverse Reactions with Muscular weakness
Adverse Reactions with Myalgia
Adverse Reactions with Muscle pain
Adverse Reactions with Muscle spasms
Adverse Reactions Injection site pain
Adverse Reactions with Hypertension
Arm Description
Biceps 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 (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 (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 (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 (finger flexors) Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Adductor 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 (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 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) = Slight increase = Moderate increase = Considerable increase = Limb rigid (very severe).
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) = Slight increase = Moderate increase = Considerable increase = Limb rigid (very severe).
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) = Slight increase = Moderate increase = Considerable increase = Limb rigid (very severe).
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) = Slight increase = Moderate increase = Considerable increase = Limb rigid (very severe).
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.
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02074150
Brief Title
ASIS for Botox in Upper Limb Spasticity
Acronym
ASISinULS
Official Title
ASIS for Botox in Upper Limb Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
li nguyen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biceps Brachii
Arm Type
Experimental
Arm Description
Biceps Brachii (elbow flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Arm Title
Flexor Carpi Radialis
Arm Type
Experimental
Arm Description
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.
Arm Title
Flexor carpi ulnaris
Arm Type
Experimental
Arm Description
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.
Arm Title
Flexor digitorum profundus
Arm Type
Experimental
Arm Description
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.
Arm Title
Flexor digitorum sublimis
Arm Type
Experimental
Arm Description
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.
Arm Title
Adductor pollicis
Arm Type
Experimental
Arm Description
Adductor pollicis (thumb flexors)
Gadolinium Magnevist® (gadopentetate dimeglumine)
.1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.
Arm Title
Flexor pollicis longus
Arm Type
Experimental
Arm Description
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.
Arm Title
Change from Baseline in Elbow Ashworth
Arm Type
Experimental
Arm Description
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)
= Slight increase
= Moderate increase
= Considerable increase
= Limb rigid (very severe).
Arm Title
Change from Baseline in Wrist Ashworth
Arm Type
Experimental
Arm Description
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)
= Slight increase
= Moderate increase
= Considerable increase
= Limb rigid (very severe).
Arm Title
Change from Baseline in Finger Ashworth
Arm Type
Experimental
Arm Description
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)
= Slight increase
= Moderate increase
= Considerable increase
= Limb rigid (very severe).
Arm Title
Change from Baseline in Thumb Ashworth
Arm Type
Experimental
Arm Description
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)
= Slight increase
= Moderate increase
= Considerable increase
= Limb rigid (very severe).
Arm Title
Change from Baseline in PGAS
Arm Type
Experimental
Arm Description
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.
Arm Title
Adverse Reactions with Facial paresis
Arm Type
Experimental
Arm Description
Facial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30
Arm Title
Adverse Reactions with Eyelid ptosis
Arm Type
Experimental
Arm Description
Eyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Bronchitis
Arm Type
Experimental
Arm Description
Bronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Neck pain
Arm Type
Experimental
Arm Description
Neck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Muscle stiffness
Arm Type
Experimental
Arm Description
Musculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Muscular weakness
Arm Type
Experimental
Arm Description
Muscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Myalgia
Arm Type
Experimental
Arm Description
Myalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Muscle pain
Arm Type
Experimental
Arm Description
Musculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Muscle spasms
Arm Type
Experimental
Arm Description
Muscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions Injection site pain
Arm Type
Experimental
Arm Description
Injection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Arm Title
Adverse Reactions with Hypertension
Arm Type
Experimental
Arm Description
Hypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Gadolinium Magnevist® (gadopentetate dimeglumine)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Gadolinium Magnevist® (gadopentetate dimeglumine)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gadolinium
Other Intervention Name(s)
Gadolinium Magnevist® (gadopentetate dimeglumine)
Intervention Description
Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox intramuscularly at Week 6
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox intramuscularly at Week 12,
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox intramuscularly at Week 18
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox intramuscularly at Week 24
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox intramuscularly at Week 30
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox subdermally at Week 6
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox subdermally at Week 12
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox subdermally at Week 18
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox subdermally at Week 24
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Efficacy of Botox subdermally at Week 30
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Adverse Reactions of Botox intramuscularly
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Adverse Reactions of Botox subdermally
Other Intervention Name(s)
Botox (onabotulinumtoxinA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative Prolongation Ability Score for Gadolinium subdermally injected.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity.
Description
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).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Adverse Reactions of Botox intramuscularly vs. subdermally in Upper Limb Spasticity
Description
Adverse Reactions of Botox intramuscularly vs. subdermally:
Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Nguyen, MD
Phone
(714)-453-7857
Email
dr.li.nguyen@asis-inc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thanh Phung, MD
Phone
714-893-1915
Email
thanhphung@idit-inc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Nguyen, MD
Organizational Affiliation
AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thanh Phung,, MD
Organizational Affiliation
AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Automatic Subdermal Injector System, Inc
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Nguyen, MD
Phone
714-453-7857
Email
dr.li.nguyen@asis-inc.com
First Name & Middle Initial & Last Name & Degree
Thanh Phung,, MD
Phone
7148931915
Email
thanhphung@idit-inc.com
First Name & Middle Initial & Last Name & Degree
Li Nguyen, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23515199
Citation
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.
Results Reference
background
PubMed Identifier
16763467
Citation
Knopp 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. Erratum In: Invest Radiol. 2006 Sep;41(9):667.
Results Reference
background
PubMed Identifier
11991094
Citation
Turner-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.
Results Reference
background
PubMed Identifier
16541938
Citation
Patrick 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.
Results Reference
background
PubMed Identifier
24361062
Citation
Jost 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.
Results Reference
background
PubMed Identifier
23864518
Citation
Baker 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.
Results Reference
background
PubMed Identifier
23776717
Citation
Ghasemi 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.
Results Reference
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ASIS for Botox in Upper Limb Spasticity
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