Trial Outcomes & Findings for Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia (NCT NCT02334683)
NCT ID: NCT02334683
Last Updated: 2021-11-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
4 weeks and 16 weeks
Results posted on
2021-11-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First 12 Week Period
STARTED
|
10
|
10
|
|
First 12 Week Period
COMPLETED
|
9
|
10
|
|
First 12 Week Period
NOT COMPLETED
|
1
|
0
|
|
Second 12 Week Period
STARTED
|
9
|
10
|
|
Second 12 Week Period
COMPLETED
|
9
|
9
|
|
Second 12 Week Period
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
First 12 Week Period
Lost to Follow-up
|
1
|
0
|
|
Second 12 Week Period
Adverse Event
|
0
|
1
|
Baseline Characteristics
Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
Baseline characteristics by cohort
| Measure |
Electrophysiologic Guidance Then Ultrasound Guidance
n=9 Participants
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.
|
Ultrasound Guidance Then Electrophysiologic Guidance
n=10 Participants
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.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
57.53 years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Diagnosis
Spasticity
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Diagnosis
Dystonia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks and 16 weeksclinical 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.
Outcome measures
| Measure |
Electrophysiologic Guidance
n=18 Participants
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 .
|
Ultrasound Guidance
n=19 Participants
Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.
|
|---|---|---|
|
Change in Patient Global Impression of Change
|
53.1 score on a scale
Interval 40.2 to 66.0
|
51.5 score on a scale
Interval 38.9 to 64.0
|
SECONDARY outcome
Timeframe: 4 weeks and 16 weekspatient 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.
Outcome measures
| Measure |
Electrophysiologic Guidance
n=18 Participants
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 .
|
Ultrasound Guidance
n=19 Participants
Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.
|
|---|---|---|
|
Change in Visual Analog Scale
|
54.72 score on a scale
Standard Deviation 32.21
|
52.37 score on a scale
Standard Deviation 31.36
|
SECONDARY outcome
Timeframe: 4 weeks and 16 weeksMuscle 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.
Outcome measures
| Measure |
Electrophysiologic Guidance
n=18 Participants
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 .
|
Ultrasound Guidance
n=19 Participants
Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.
|
|---|---|---|
|
Change in Muscle Strength
|
29.89 score on a scale
Standard Deviation 27.78
|
20.63 score on a scale
Standard Deviation 28.27
|
Adverse Events
Electrophysiologic Guidance
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Ultrasound Guidance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Electrophysiologic Guidance
n=19 participants at risk
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 .
|
Ultrasound Guidance
n=19 participants at risk
Ultrasound guidance, using sound waves through a wand directed towards the targeted muscles.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Severe Weakness
|
5.3%
1/19 • 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
|
0.00%
0/19 • 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
|
|
Musculoskeletal and connective tissue disorders
Muscle Atrophy
|
5.3%
1/19 • 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
|
0.00%
0/19 • 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
|
Other adverse events
Adverse event data not reported
Additional Information
David Simpson, M.D.
Icahn School of Medicine at Mount Sinai
Phone: (212) 241-8748
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60