| ID | Type | Description | Link |
|---|---|---|---|
| #86127 | Other Identifier | Allergan Pharmaceuticals Funding Agency |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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This study seeks to compare the use of ultrasound and electrophysiologic techniques to target muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity. Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard ways of locating muscles during a treatment of BoNT injection.
This is a study to investigate the use of two targeting techniques for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity: Electrophysiologic guidance, using electrical stimulation, and ultrasound. Subjects will be selected from the clinical programs of both Icahn School of Medicine at Mount Sinai and the National Institutes of Health who are already receiving onabotulinum toxin A injections clinically. The study will consist of four visits. Visit one consists of screening subjects who will then be consented and randomized to one of the two treatment techniques for their ona-BoNT injection: 1) Electrophysiologic guidance using electrical stimulation or 2) ultrasound. Visit 2 will occur at week 4 where the subjects will return for a follow up visit to have blinded evaluator measurements of efficacy and strength and capture safety data. Visit 3 will be at week 12 when subjects will cross over and have the alternate treatment technique during their ona-BoNT injection. Visit 4 will occur at week 16 as the final assessment where subjects will have measurements of efficacy and strength and capture safety data by the blinded evaluator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrophysiologic guidance | Experimental | Electrophysiologic guidance, using electrical stimulation |
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| Ultrasound guidance | Active Comparator | Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical stimulation | Device | The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Global Impression of Change | clinical or patient self-rating form for grading evaluation of the treatment at 16 weeks as compared to at 4 weeks. Full scale from 0 = no improvement and 100 normal use. Higher score indicates better health outcome. | 4 weeks and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analog Scale | patient perception of satisfaction and comfort at 16 weeks as compared to at 4 weeks. Full scale from 0 = no improvement to 100 = normal. Higher score indicates more improvement. | 4 weeks and 16 weeks |
| Change in Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Simpson, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninds, Nih | Bethesda | Maryland | 20892 | United States | ||
| Icahn School of Medicine at Mount Sinai |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrophysiologic Guidance Then Ultrasound Guidance | Electrophysiologic guidance, using electrical stimulation to locate the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle. Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First 12 Week Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2014 |
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| Ultrasound | Device | The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves. |
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Muscle strength measured by dynamometry at 16 weeks as compared to at 4 weeks. Full scale 0 = no weakness and 100 is unable to move. Higher score indicates poorer health outcome. |
| 4 weeks and 16 weeks |
| New York |
| New York |
| 10029 |
| United States |
| FG001 | Ultrasound Guidance Then Electrophysiologic Guidance | Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles. Electrophysiologic guidance, using electrical stimulation to locate the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle. |
| COMPLETED |
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| NOT COMPLETED |
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| Second 12 Week Period |
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Analysis was done only on the participants who completed at least one cycle - 1 subject from MSSM was lost to follow and is not included
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| ID | Title | Description |
|---|---|---|
| BG000 | Electrophysiologic Guidance Then Ultrasound Guidance | Electrophysiologic guidance, using electrical stimulation Electrical stimulation: The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves. Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles. Ultrasound: The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves. |
| BG001 | Ultrasound Guidance Then Electrophysiologic Guidance | Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles. Ultrasound: The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves. Electrophysiologic guidance, using electrical stimulation Electrical stimulation: The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient Global Impression of Change | clinical or patient self-rating form for grading evaluation of the treatment at 16 weeks as compared to at 4 weeks. Full scale from 0 = no improvement and 100 normal use. Higher score indicates better health outcome. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 4 weeks and 16 weeks |
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| Secondary | Change in Visual Analog Scale | patient perception of satisfaction and comfort at 16 weeks as compared to at 4 weeks. Full scale from 0 = no improvement to 100 = normal. Higher score indicates more improvement. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks and 16 weeks |
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| Secondary | Change in Muscle Strength | Muscle strength measured by dynamometry at 16 weeks as compared to at 4 weeks. Full scale 0 = no weakness and 100 is unable to move. Higher score indicates poorer health outcome. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks and 16 weeks |
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16 weeks
Analysis was done only on the participants who completed at least one cycle - 1 subject from MSSM was lost to follow and is not included
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electrophysiologic Guidance | Electrical stimulation: the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by electrical stimulation using a needle . | 0 | 19 | 1 | 19 | 0 | 19 |
| EG001 | Ultrasound Guidance | Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles. | 0 | 19 | 0 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle Atrophy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Simpson, M.D. | Icahn School of Medicine at Mount Sinai | (212) 241-8748 | david.simpson@mssm.edu |
| Oct 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020821 | Dystonic Disorders |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D020820 | Dyskinesias |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Male |
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| Not Hispanic or Latino |
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| Dystonia |
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