Focal Dystonia, Spasticity, Tremor, Limb
Conditions
Keywords
Comparison, Botulinum toxin treatments, Ultrasound, Electrophysiologic, Spasticity, Focal dystonia
Brief summary
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.
Detailed description
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.
Interventions
DEVICEElectrical 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.
DEVICEUltrasound
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.
Sponsors
Allergan
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Confirmed diagnosis of focal upper extremity dystonia (FHD) or upper limb spasticity * Stable onabotulinumtoxinA dose regimen with a stable response as judged by the physician and patient for at least 2 treatment sessions.
Exclusion criteria
* Contraindications to botulinum toxin * Pregnancy or nursing * Cognitive impairment that prevents reliable outcome measures of self-report
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Global Impression of Change | 4 weeks and 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scale | 4 weeks and 16 weeks | 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. |
| Change in Muscle Strength | 4 weeks and 16 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First 12 Week Period | Lost to Follow-up | 1 | 0 |
| Second 12 Week Period | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Electrophysiologic Guidance Then Ultrasound Guidance | Ultrasound Guidance Then Electrophysiologic Guidance | Total |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 15.4 | 59.7 years STANDARD_DEVIATION 10.8 | 57.53 years STANDARD_DEVIATION 12.99 |
| Diagnosis Dystonia | 4 Participants | 4 Participants | 8 Participants |
| Diagnosis Spasticity | 5 Participants | 6 Participants | 11 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 Participants | 10 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 1 / 19 | 0 / 19 |
Outcome results
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.
Time frame: 4 weeks and 16 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Electrophysiologic Guidance | Change in Patient Global Impression of Change | 53.1 score on a scale |
| Ultrasound Guidance | Change in Patient Global Impression of Change | 51.5 score on a scale |
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.
Time frame: 4 weeks and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrophysiologic Guidance | Change in Muscle Strength | 29.89 score on a scale | Standard Deviation 27.78 |
| Ultrasound Guidance | Change in Muscle Strength | 20.63 score on a scale | Standard Deviation 28.27 |
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.
Time frame: 4 weeks and 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrophysiologic Guidance | Change in Visual Analog Scale | 54.72 score on a scale | Standard Deviation 32.21 |
| Ultrasound Guidance | Change in Visual Analog Scale | 52.37 score on a scale | Standard Deviation 31.36 |