Back to results

Botox for Cervical Dystonia Following EMG Mapping

Primary Purpose

Cervical Dystonia

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Botulinum toxin A

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring dystonia, cervical dystonia, Botox, idiopathic primary cervical dystonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Male or female subjects, 18 to 75 years of age.
Ability to follow study instructions and complete all required visits.
Subject meets diagnostic criteria for idiopathic primary cervical dystonia.
Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection.
Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an outside facility.
Patients will not have received Botulinum toxin within 16 weeks of the start of the study.
In order to not confound the clinical response to BTX-A injections, all patients enrolled must have been on a stable medication regimen for 30 days. If they are not on medication at the initiation of the study, they will not be started on medication. Patients must be on the same medication regimen through the entire study including assessment of both single lead EMG based injections and "mapping" based injections. Medications cannot be stopped during the study to avoid confounding the clinical response to BTX-A.

Exclusion Criteria:

Known allergy or sensitivity to any of the components in BTX-A.
Uncontrolled clinically significant medical condition other than the condition under evaluation
Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
Participation in another medication or device study or within 3 months of enrollment in this study.
Patients know to have a positive frontalis test or have previously tested positive for the presence of BTX-A antibodies will be excluded.
Any known evidence of cervical contractures or significant spinal deformity.

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard EMG-guided Botox injection

Multi-channel EMG-guided Botox injection

Arm Description

All patients will undergo injection using conventional single channel EMG-guided technique. This will be used as a baseline for multi-channel mapping-based injections. Patients will be randomized to undergo single-channel vs. multi-channel assessment upon study entry and will then cross over to the alternate arm.

Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel EMG-guided Botox, depending on which group they are assigned in the cross-over design.

Outcomes

Primary Outcome Measures

Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)

Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale

Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).

Secondary Outcome Measures

Full Information

NCT ID

NCT00773253

First Posted

October 14, 2008

Last Updated

March 6, 2020

Sponsor

University of California, San Francisco

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00773253

Brief Title

Botox for Cervical Dystonia Following EMG Mapping

Official Title

Pre-injection, Multi-channel EMG Mapping to Optimize Botulinum Toxin Type A Efficacy in Cervical Dystonia.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine how to improve treatment of patients with cervical dystonia who have not been helped with standard Botox injections. This study is for patients with cervical dystonia who have not benefited from treatment with Botox using conventional "single lead electromyographic (EMG) techniques" for injection. The study aim is to see if these patients may have significantly more benefit if their Botox is injected into muscles that have been chosen with a multi-channel EMG mapping study of the neck prior to Botox injection.

Detailed Description

The most common type of primary late-onset dystonia is cervical dystonia. Botulinum toxin A (BTX-A) injections are a safe and effective treatment for cervical dystonia in a majority of patients, however, a significant minority of patients (between 15 and 25%) have a suboptimal response to Botulinum toxin therapy. It is unclear why some patients do not respond maximally to neurotoxin therapy. Studies using needle electromyographic "mapping" in the evaluation of cervical dystonia have revealed that clinical examination alone is insufficient for determining which muscles contribute to the dystonic movement. When compared to needle electromyography (EMG) "mapping studies", experienced movement disorders specialists correctly identify only 59% of active muscles and believe that 25% of muscles which upon EMG evaluation are found to be quiescent, are involved in the dystonia. The selection of incorrect muscles for injection of Botulinum toxin may explain why some patients have a sub-optimal response. This study seeks to measure outcomes when the muscles involved in dystonia are identified using "mapping" via an 8-12 channel EMG. In the proposed study, the most involved/active dystonic muscles will be correctly identified through simultaneous 8-12 channel mapping resulting in a more informed injection strategy, which may improve response to Botulinum toxin A treatment as compared to single lead EMG based injections. This study changes routine clinical care only by adding the step of studying the muscles of the neck with simultaneous EMG mapping to allow a more objective injection strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Dystonia

Keywords

dystonia, cervical dystonia, Botox, idiopathic primary cervical dystonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard EMG-guided Botox injection

Arm Type

Active Comparator

Arm Description

Arm Title

Multi-channel EMG-guided Botox injection

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin A

Other Intervention Name(s)

Botox

Intervention Description

All patients will be treated with Botox using both single-channel and multi-channel EMG mapping.

Primary Outcome Measure Information:

Title

Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS)

Time Frame

pre-injection, week 16, 20, 36, and 40

Title

Mean Percentage Change in Total Toronto Western Spasmodic Torticollis Rating Scale

Description

Mean Percentage change in Toronto Western Spasmodic Torticollis Rating Scale. This scale ranges from 0 (normal) to 85 (very severe).

Time Frame

baseline and 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Male or female subjects, 18 to 75 years of age. Ability to follow study instructions and complete all required visits. Subject meets diagnostic criteria for idiopathic primary cervical dystonia. Subject has at least moderate severity Cervical Dystonia, with a baseline rating of at least 30 on the total TWSTRS and at least 15 on the TWSTRS motor severity subsection. Patients have had a suboptimal response to 2 previous Botulinum toxin injections at an outside facility. Patients will not have received Botulinum toxin within 16 weeks of the start of the study. In order to not confound the clinical response to BTX-A injections, all patients enrolled must have been on a stable medication regimen for 30 days. If they are not on medication at the initiation of the study, they will not be started on medication. Patients must be on the same medication regimen through the entire study including assessment of both single lead EMG based injections and "mapping" based injections. Medications cannot be stopped during the study to avoid confounding the clinical response to BTX-A. Exclusion Criteria: Known allergy or sensitivity to any of the components in BTX-A. Uncontrolled clinically significant medical condition other than the condition under evaluation Females with a positive pregnancy test, or who are breast-feeding, planning a pregnancy during the study, who think that they may be pregnant at the start of the study or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study. Participation in another medication or device study or within 3 months of enrollment in this study. Patients know to have a positive frontalis test or have previously tested positive for the presence of BTX-A antibodies will be excluded. Any known evidence of cervical contractures or significant spinal deformity.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Graham A. Glass, M.D.

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Botox for Cervical Dystonia Following EMG Mapping

We'll reach out to this number within 24 hrs