SpasticityNCT02334683
Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
A study testing Electrical stimulation and Ultrasound in people with Spasticity and Focal Dystonia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Focal Dystonia, Tremor, Limb
- What is being tested?
- Electrical stimulation and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2015to 3 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to botulinum toxin
- Pregnancy or nursing
- Cognitive impairment that prevents reliable outcome measures of self-report
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ninds, Nih
Bethesda, Maryland, 20892
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity
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.
Read the 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.
- Conditions
- Spasticity, Focal Dystonia, Tremor, Limb
- Being tested
- Electrical stimulation, Ultrasound
- Keywords
- Comparison, Botulinum toxin treatments, Ultrasound, Electrophysiologic, Spasticity, Focal dystonia
- Medical subject headings
- Muscle Spasticity, Dystonic Disorders, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationDevice
Also called E-stim
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.
UltrasoundDevice
Also called Sonography
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.
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiologic guidance | Experimental | Electrophysiologic guidance, using electrical stimulation Receives: Device: Electrical stimulation |
| Ultrasound guidance | Active comparator | Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks and 16 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks and 16 weeks
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.
Measured: 4 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study start28 Oct 2015
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, David M. Simpson, Icahn School of Medicine at Mount Sinai
- Investigators
- David Simpson, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334683
- Sponsor's protocol ID
- GCO 14-1113
- Other IDs
- #86127
- Status last verified
- Oct 2021
- First submitted
- 24 Dec 2014
- Last updated
- 26 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Electrophysiologic And Ultrasound Guidance For Onabotulinum Toxin A Injections in Focal Upper Extremity Dystonia And Spasticity
- ClinicalTrials.gov ID
- NCT02334683
- Acronym / sponsor ID
- GCO 14-1113
- Conditions
- Spasticity, Focal Dystonia, Tremor, Limb
- Keywords
- Comparison, Botulinum toxin treatments, Ultrasound, Electrophysiologic, Spasticity, Focal dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 28 Oct 2015 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Posted 26 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrophysiologic guidance | Experimental | Device: Electrical stimulationElectrophysiologic guidance, using electrical stimulation |
| Ultrasound guidance | Active comparator | Device: UltrasoundUltrasound guidance,using sound waves through a wand directed towards the targeted muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Contraindications to botulinum toxin
- Pregnancy or nursing
- Cognitive impairment that prevents reliable outcome measures of self-report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulationAlso: E-stimThe 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. | Device | Electrophysiologic guidance |
| UltrasoundAlso: SonographyThe purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves. | Device | Ultrasound guidance |
Primary outcome
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. Full scale from 0 = no improvement and 100 normal use. Higher score indicates better health outcome.
2 secondary outcomes
Change in Visual Analog Scale
Time frame: 4 weeks and 16 weeks
Change in Muscle Strength
Time frame: 4 weeks and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Spasticity
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
RecruitingObservational study
Rare Disease Registry Database for Movement Disorders in Southern Anhui Province
Motor Neuron Diseases, Spinocerebellar Ataxias
Recruiting
Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation
SCI - Spinal Cord Injury, Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
Spinal Cord Injury, Spasticity
Enrolling by invitationObservational study
Effect of Treatment Dairy for Spasticity
Spasticity, Muscle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Simpson, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation and Ultrasound in people with Spasticity and Focal Dystonia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Global Impression of Change (time frame: 4 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.