NCT02334683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
10 months until next milestone

Study Start

First participant enrolled

October 28, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

October 1, 2021

Enrollment Period

4.4 years

First QC Date

December 24, 2014

Results QC Date

October 28, 2021

Last Update Submit

October 28, 2021

Conditions

SpasticityFocal DystoniaTremor, Limb

Keywords

ComparisonBotulinum toxin treatmentsUltrasoundElectrophysiologicSpasticityFocal dystonia

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks and 16 weeks

Secondary Outcomes (2)

  • Change in Visual Analog Scale

    4 weeks and 16 weeks

  • Change in Muscle Strength

    4 weeks and 16 weeks

Study Arms (2)

Electrophysiologic guidance

EXPERIMENTAL

Electrophysiologic guidance, using electrical stimulation

Device: Electrical stimulation

Ultrasound guidance

ACTIVE COMPARATOR

Ultrasound guidance,using sound waves through a wand directed towards the targeted muscles.

Device: Ultrasound

Interventions

Electrical stimulationDEVICE

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.

Also known as: E-stim
Electrophysiologic guidance
UltrasoundDEVICE

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.

Also known as: Sonography
Ultrasound guidance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Contraindications to botulinum toxin
  • Pregnancy or nursing
  • Cognitive impairment that prevents reliable outcome measures of self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ninds, Nih

Bethesda, Maryland, 20892, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Muscle SpasticityDystonic DisordersTremor

Interventions

Electric StimulationUltrasonography

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMovement DisordersCentral Nervous System DiseasesDyskinesias

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
David Simpson, M.D.
Organization
Icahn School of Medicine at Mount Sinai
david.simpson@mssm.edu
(212) 241-8748

Study Officials

  • David Simpson, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

December 24, 2014

First Posted

January 8, 2015

Study Start

October 28, 2015

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

November 26, 2021

Results First Posted

November 26, 2021

Record last verified: 2021-10

Locations

US(2)