Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Allergan | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard EMG-guided Botox injection | Active Comparator | 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. |
|
| Multi-channel EMG-guided Botox injection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A | Drug | All patients will be treated with Botox using both single-channel and multi-channel EMG mapping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS) | pre-injection, week 16, 20, 36, and 40 | |
| 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). | baseline and 48 weeks |
Not provided
Not provided
Inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Graham A. Glass, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard EMG Guided Injections Then Multi-channel Injections | All patients will undergo injection using conventional single channel (standard)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. |
| FG001 | Multi-channel EMG-guided Botox Injection Then Standard EMG Inj | Patients will receive multi-channel EMG-guided Botox injection before or after they have been treated with single-channel (standard) EMG-guided Botox, depending on which group they are assigned in the cross-over design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Week 0-24) |
|
| ||||||||||||||||||
| Second Intervention (Week 24-48) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard EMG Guided Injections Then Multi-channel | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pre- and Post-injection Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS): Global Clinical Impression Scale (GCI); Visual Analog Scale(VAS) | PI left institution. Efforts to contact PI to obtain data have been unsuccessful. | Posted | pre-injection, week 16, 20, 36, and 40 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard EMG Guided Injections | All patients underwent single channel (standard)EMG-guided technique. |
Not provided
Not provided
One patient received single channel injection, but did not get multi-channel injection because the frontalis test showed immunity to botulinum toxin indicating no possibility of clinical benefit. This is an exclusion criterion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graham A. Glass, MD | University of California San Francisco | 415-353-2311 | Graham.Glass@ucsf.edu |
Not provided
| ID | Term |
|---|---|
| D014103 | Torticollis |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| NOT COMPLETED |
|
| BG001 |
| Multi-channel EMG-guided Botox Injection Then Single Channel |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. Botulinum toxin A: All patients will be treated with Botox using both single-channel and multi-channel EMG mapping. |
|
| Primary | 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). | All participants that completed all phases of the study | Posted | Mean | Standard Deviation | percent change | baseline and 48 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Multi-channel EMG-guided Botox Injection | Patients will receive multi-channel EMG-guided Botox injection. | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |