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Cervical Dystonia Adults , | ASIS for Botox in Cervical Dystonia

Cervical Dystonia Adults , research study

What is the primary objective of this study?

Botox acts 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.

Who is eligible to participate?

Inclusion Criteria: •Adults with cervical dystonia, or abnormal head position and neck pain for these 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus. Exclusion Criteria: - Known Hypersensitivity to Botulinum Toxin or to any of the components in the formulation. - Infection at the Injection Site(s). - Has any medical condition that may increase their risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function. - Has profound atrophy or weakness of muscles in the target areas of injection. - Had previously received surgical or other denervation treatment for their symptoms or had a known history of neuromuscular disorder.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cervical Dystonia Adults ,

Abnormal Head Position and Neck Pain for These 7 Muscle Groups: Splenius,Scalene,Sterno-cleido-mastoid,Levator Scapulae,Semispinalis,Trapezius,and Longissimus.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:GadoliniumGadolinium .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:GadoliniumGadolinium .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:GadoliniumRelative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.

Drug:Efficacy of Botox intramuscularly at Week 6Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox intramuscularly at Week 12Efficacy of Botox intramuscularly at Week 12, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).

Drug:Efficacy of Botox intramuscularly at Week 18Efficacy of Botox intramuscularly at Week 18, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).

Drug:Efficacy of Botox intramuscularly at Week 24Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox intramuscularly at Week 30Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox subdermally at Week 6Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox subdermally at Week 12Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox subdermally at Week 18Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox subdermally at Week 24Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Efficacy of Botox subdermally at Week 30Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).

Drug:Adverse Reactions of Botox intramuscularlyAdverse 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 of Botox subdermallyAdverse 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SpleniusGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

ScaleneGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Sterno-cleido-mastoidGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Levator ScapulaeGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

SemispinalisGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

TrapeziusGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

LongissimusGadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9ccNS intramuscularly for 30 patients, and subdermally with ASIS Device for 30 patients.

Change from Baseline in Pain FrequencyChange from Baseline in Pain Frequency 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.

Change from Baseline in Pain IntensityChange from Baseline in Pain Intensity 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 severity on scales of 0(no pain) to 4(constant or extremely severe intensity).

Change from Baseline in CDSSChange from Baseline in CDSS 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 CDSS or Cervical Dystonia Severity Scale quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS allots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54).

Percent of Patients with Improved PGASPercent of Patients with Improved 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 paresisFacial paresis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with Eyelid ptosisEyelid ptosis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with BronchitisBronchitis as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with Neck painNeck pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with Muscle stiffnessMusculoskeletal stiffness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with Muscular weaknessMuscular weakness as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with MyalgiaMyalgia as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with Muscle painMusculoskeletal pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with Muscle spasmsMuscle spasms as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions Injection site painInjection site pain as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Adverse Reactions with HypertensionHypertension as Adverse Reactions of Botox intramuscularly vs.Adverse Reactions of Botox subdermally at Week 30.

Study Status

Unknown status

Start Date: January 2016

Completed Date: June 2017

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Relative Prolongation Ability Score for Gadolinium subdermally injected.

Secondary Outcome: Efficacy of Botox intramuscularly vs. subdermally in Cervical Dystonia.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: li nguyen

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02074293

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. Review.

Discuss Dystonia