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

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT02334683
• Collaborator: Allergan (Industry)
• Enrollment: 20
• Locations: 2
• Arms: 2
• Actual Duration (Months): 52.2
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spasticity; Focal Dystonia; Tremor, Limb	Device: Electrical stimulation; Device: Ultrasound	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity
• Actual Study Start Date: Oct 28, 2015
• Actual Primary Completion Date: Mar 3, 2020
• Actual Study Completion Date: Mar 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electrophysiologic guidance Electrophysiologic guidance, using electrical stimulation	Device: 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.; Other Names: E-stim
Active Comparator: Ultrasound guidance Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.	Device: 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.; Other Names: Sonography

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ninds, Nih	Bethesda	Maryland	United States	20892
2	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• Allergan

Investigators

• Principal Investigator: David Simpson, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 2, 2014

More Information

Publications

None provided.

• Responsible Party: David M. Simpson, Professor of Neurology, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT02334683
• Other Study ID Numbers: GCO 14-1113; #86127; NCT02326818
• First Posted: Jan 8, 2015
• Last Update Posted: Nov 26, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by David M. Simpson, Professor of Neurology, Icahn School of Medicine at Mount Sinai: Comparison; Botulinum toxin treatments; Ultrasound; Electrophysiologic; Spasticity; Focal dystonia
• Additional relevant MeSH terms: Muscle Spasticity; Dystonia; Dystonic Disorders; Tremor

Study Results

Participant Flow

Arm/Group Title	Electrophysiologic Guidance Then Ultrasound Guidance	Ultrasound Guidance Then Electrophysiologic Guidance
Arm/Group Description	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
Period Title: First 12 Week Period
STARTED	9	10
COMPLETED	9	9
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Electrophysiologic Guidance Then Ultrasound Guidance	Ultrasound Guidance Then Electrophysiologic Guidance	Total
Arm/Group Description	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 Participants	9	10	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (15.4)	59.7 (10.8)	57.53 (12.99)
Sex: Female, Male (Count of Participants)
Female	4 44.4%	2 20%	6 31.6%
Male	5 55.6%	8 80%	13 68.4%
Race/Ethnicity, Customized (Count of Participants)
White	9 100%	10 100%	19 100%
Not Hispanic or Latino	9 100%	10 100%	19 100%
Diagnosis (Count of Participants)
Spasticity	5 55.6%	6 60%	11 57.9%
Dystonia	4 44.4%	4 40%	8 42.1%

Outcome Measures

1. Primary Outcome

Title	Change in Patient Global Impression of Change
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electrophysiologic Guidance	Ultrasound Guidance
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.
Measure Participants	18	19
Least Squares Mean (95% Confidence Interval) [score on a scale]	53.1	51.5

2. Secondary Outcome

Title	Change in Visual Analog Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electrophysiologic Guidance	Ultrasound Guidance
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.
Measure Participants	18	19
Mean (Standard Deviation) [score on a scale]	54.72 (32.21)	52.37 (31.36)

3. Secondary Outcome

Title	Change in Muscle Strength
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Electrophysiologic Guidance	Ultrasound Guidance
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.
Measure Participants	18	19
Mean (Standard Deviation) [score on a scale]	29.89 (27.78)	20.63 (28.27)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Electrophysiologic Guidance		Ultrasound Guidance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		0/19 (0%)
Musculoskeletal and connective tissue disorders
Severe Weakness	1/19 (5.3%)		0/19 (0%)
Muscle Atrophy	1/19 (5.3%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Electrophysiologic Guidance		Ultrasound Guidance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.