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Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia

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ClinicalTrials.gov Identifier: NCT02334683
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
David M. Simpson, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions Spasticity
Focal Dystonia
Tremor, Limb
Interventions Device: Electrical stimulation
Device: Ultrasound
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Electrophysiologic Guidance Then Ultrasound Guidance Ultrasound Guidance Then Electrophysiologic Guidance
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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, 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.

Period Title: First 12 Week Period
Started 10 10
Completed 9 10
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Period Title: Second 12 Week Period
Started 9 10
Completed 9 9
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Electrophysiologic Guidance Then Ultrasound Guidance Ultrasound Guidance Then Electrophysiologic Guidance Total
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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,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 of all reporting groups
Overall Number of Baseline Participants 9 10 19
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 10 participants 19 participants
55.1  (15.4) 59.7  (10.8) 57.53  (12.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Female
4
  44.4%
2
  20.0%
6
  31.6%
Male
5
  55.6%
8
  80.0%
13
  68.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
White
9
 100.0%
10
 100.0%
19
 100.0%
Not Hispanic or Latino
9
 100.0%
10
 100.0%
19
 100.0%
Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 19 participants
Spasticity
5
  55.6%
6
  60.0%
11
  57.9%
Dystonia
4
  44.4%
4
  40.0%
8
  42.1%
1.Primary Outcome
Title Change in Patient Global Impression of Change
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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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electrophysiologic Guidance Ultrasound Guidance
Hide Arm/Group Description:
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, using sound waves through a wand directed towards the targeted muscles.
Overall Number of Participants Analyzed 18 19
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
53.1
(40.2 to 66.0)
51.5
(38.9 to 64.0)
2.Secondary Outcome
Title Change in Visual Analog Scale
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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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electrophysiologic Guidance Ultrasound Guidance
Hide Arm/Group Description:
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, using sound waves through a wand directed towards the targeted muscles.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
54.72  (32.21) 52.37  (31.36)
3.Secondary Outcome
Title Change in Muscle Strength
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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.

Time Frame 4 weeks and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electrophysiologic Guidance Ultrasound Guidance
Hide Arm/Group Description:
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, using sound waves through a wand directed towards the targeted muscles.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
29.89  (27.78) 20.63  (28.27)
Time Frame 16 weeks
Adverse Event Reporting Description 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
 
Arm/Group Title Electrophysiologic Guidance Ultrasound Guidance
Hide Arm/Group Description 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, using sound waves through a wand directed towards the targeted muscles.
All-Cause Mortality
Electrophysiologic Guidance Ultrasound Guidance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
Electrophysiologic Guidance Ultrasound Guidance
Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   0/19 (0.00%) 
Musculoskeletal and connective tissue disorders     
Severe Weakness   1/19 (5.26%)  0/19 (0.00%) 
Muscle Atrophy   1/19 (5.26%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Electrophysiologic Guidance Ultrasound Guidance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Simpson, M.D.
Organization: Icahn School of Medicine at Mount Sinai
Phone: (212) 241-8748
EMail: david.simpson@mssm.edu
Layout table for additonal information
Responsible Party: David M. Simpson, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02334683    
Obsolete Identifiers: NCT02326818
Other Study ID Numbers: GCO 14-1113
#86127 ( Other Identifier: Allergan Pharmaceuticals Funding Agency )
First Submitted: December 24, 2014
First Posted: January 8, 2015
Results First Submitted: October 28, 2021
Results First Posted: November 26, 2021
Last Update Posted: November 26, 2021