Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02334683|
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spasticity Focal Dystonia Tremor, Limb||Device: Electrical stimulation Device: Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
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 Name: E-stim
Active Comparator: Ultrasound guidance
Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.
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 Name: Sonography
- Change in Patient Global Impression of Change [ Time Frame: 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
- Change in Visual Analog scale [ Time Frame: 4 weeks and 16 weeks ]patient perception of satisfaction and comfort at 16 weeks as compared to at 4 weeks.
- Change in muscle strength [ Time Frame: 4 weeks and 16 weeks ]Muscle strength measured by dynamometry at 16 weeks as compared to at 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334683
|Contact: David Simpson, MDfirstname.lastname@example.org|
|Contact: Steven Frucht, MDemail@example.com|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Contact: Codrin Lungu, MD 301-402-0976 firstname.lastname@example.org|
|Principal Investigator: Condrin Lungu, MD|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Mary Catherine George 212-241-0784 email@example.com|
|Principal Investigator: David Simpson, MD|
|Principal Investigator:||David Simpson, MD||Icahn School of Medicine at Mount Sinai|