Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the efficacy of botulinum toxin (BoNT) injections in forearm flexors plus extensor muscles versus flexors alone for the treatment of essential hand tremor (ET).
The investigators propose a pilot, single center, double blind, randomized, parallel, placebo controlled trial comparing 2 (BoNT) injection patterns for treatment of moderate to severe essential tremor. The investigators will recruit 20 patients with (ET).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 units of abobotulinumtoxinA | Experimental | 150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) |
|
| 75 units of abobotulinumtoxinA | Experimental | 75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin | Drug | Botulinum injections into dominant upper extremity using protocol outlined above. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale
Higher scores represent better outcome. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none/normal and 4 = very severe/high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. | Baseline and 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hubert Fernandez, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Twenty-one patients were enrolled to participate, but one patient was removed from the sample due to being an extreme outlier on most outcomes of interest, and another patient dropped out after the baseline visit.
This was a 12-week, pilot, randomized (1:1 ratio), double-blind, placebo-controlled study of 21 patients with ET evaluated by a movement disorders specialist at the Cleveland Clinic.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Flexors Alone | 75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above. |
| FG001 | Flexors Plus Extensors |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2015 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above |
|
| Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by clinician on a -4 to +4 scale
Higher scores represent better outcome. | 6 weeks |
| Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index.Positive index change values indicate that the score increased and negative values indicate that the score decreased. | Baseline and 6 weeks |
| Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. | the median of the differences in grip strength between baseline and week 6, A negative value indicates a decrease in grip strength in Kg at week 6. | 6 weeks |
| 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group. | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none or normal and 4 = very severe or high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. | 12 weeks |
| 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) | 12 week post injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) Assessment of improvement graded by the clinician on a -4 to +4 scale
Higher scores represent better outcome. | 12 weeks |
| 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS) | Patient Global Impression Scale-Improvement Subscale (PGIS) Assessment of improvement graded by patient on a -4 to +4 scale
Higher scores represent better outcome. | 12 weeks |
| Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index. Positive index change values indicate that the score increased and negative values indicate that the score decreased. | Baseline and 12 weeks. |
150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU)
Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above.
Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Flexors Alone | 75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above. |
| BG001 | Flexors Plus Extensors | 150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above. Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Right-handed | Number | participants |
| ||||||||||||||||
| TRS mean | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none or normal and 4 = very severe or high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| QUEST Health status self-report, med(IQR) | QUEST ( Quality of life in Essential tremor Questionnaire ) Heath Status: In general, how would you rate your overall health? (0=very poor health, 100=excellent/perfect health) Circle: 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 | Mean | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| QUEST Quality of Life self-report, mean(SD) | Quality of Life in Essential Tremor Questionnaire (QUEST) Overall Quality of Life: Overall, how would you rate your quality of life? (0=very poor health, 100=excellent/perfect health): Circle: 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| QUEST Communication, med (IQR) | Quality of Life in Essential Tremor Questionnaire (QUEST): Dimension Communication: total questions 3 Possible answers: Each answer correspond to a numeric value : N=0 R=1 S=2 F=3 A=4 NA=blank N = Never/Not applicable R = Rarely S = Sometimes F = Frequently A = Always/Yes Scoring Algorithm: Total applicable points for each dimension/total possible points ( # of applicable questionsx 4 ) for each dimension X100 = dimension score. Maximal Score 100=worse quality of life due to tremor. Minimal score 0= Best quality of life. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| QUEST Work, med (IQR) | Quality of Life in Essential Tremor Questionnaire (QUEST): Dimension Work: total questions 6 Possible answers: Each answer correspond to a numeric value : N=0 R=1 S=2 F=3 A=4 NA=blank N = Never/Not applicable R = Rarely S = Sometimes F = Frequently A = Always/Yes Scoring Algorithm: Total applicable points for each dimension/total possible points ( # of applicable questionsx 4 ) for each dimension X100 = dimension score. Maximal Score 100=worse quality of life due to tremor. Minimal score 0= Best quality of life. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| QUEST Hobbies, med (IQR) | Quality of Life in Essential Tremor Questionnaire (QUEST): Dimension Hobbies: total questions 3 Possible answers: Each answer correspond to a numeric value : N=0 R=1 S=2 F=3 A=4 NA=blank N = Never/Not applicable R = Rarely S = Sometimes F = Frequently A = Always/Yes Scoring Algorithm: Total applicable points for each dimension/total possible points ( # of applicable questionsx 4 ) for each dimension X100 = dimension score. Maximal Score 100=worse quality of life due to tremor. Minimal score 0= Best quality of life. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| QUEST Physical, med (IQR) | Quality of Life in Essential Tremor Questionnaire (QUEST): Dimension Physical: total questions 9 Possible answers: Each answer correspond to a numeric value : N=0 R=1 S=2 F=3 A=4 NA=blank N = Never/Not applicable R = Rarely S = Sometimes F = Frequently A = Always/Yes Scoring Algorithm: Total applicable points for each dimension/total possible points ( # of applicable questionsx 4 ) for each dimension X100 = dimension score. Maximal Score 100=worse quality of life due to tremor. Minimal score 0= Best quality of life. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| QUEST Psychosocial, med (IQR) | Quality of Life in Essential Tremor Questionnaire (QUEST): Dimension Communication: total questions 9 Possible answers: Each answer correspond to a numeric value : N=0 R=1 S=2 F=3 A=4 NA=blank N = Never/Not applicable R = Rarely S = Sometimes F = Frequently A = Always/Yes Scoring Algorithm: Total applicable points for each dimension/total possible points ( # of applicable questionsx 4 ) for each dimension X100 = dimension score. Maximal Score 100=worse quality of life due to tremor. Minimal score 0= Best quality of life. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| QUEST Summary Index, med (IQR) | Quality of Life in Essential Tremor Questionnaire: Total summary index 30-item, ET-specific quality of life scale Items contribute to 5 dimensions: Physical/ADL, Psychosocial, Communication, Hobbies/Leisure, and Work/Finances. The score on each scale is a percentage of the total score possible, a higher score indicates greater dissatisfaction with that domain. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. | Mean | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| PHQ-9, med (IQR) | Patient Health Questionnaire - 9 PHQ-9 9 question items scored from : 0=not at all , 1= Several Days, 2=More than half the days, 3=nearly every day . Total score is the sum of all items. Interpretation of Total Score Total Score Depression Severity 0-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression Minimum score: 0 : no depression. Maximal Score 27 : severe depression. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| GAD-7, med (IQR) | Generalized Anxiety Disorder 7 item ( GAD-7) Total of 7 questions scored from 0=not at all , 1= several days, 2= More than half the days, 3= Nearly every day. Total score = total sum of all items. Maximal score=21, minimal Score =0 Interpretation of the score: > or = 10 probable diagnosis of Generalized anxiety disorder, Confirm by further evaluation. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety | Median | Inter-Quartile Range | Score on a scale |
| ||||||||||||||
| Age of onset, med (IQR) | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Disease duration, med (IQR) | Median | Inter-Quartile Range | Years |
| |||||||||||||||
| Main Grip Strength | Median | Inter-Quartile Range | Kg |
|
| 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 | Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale
Higher scores represent better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none/normal and 4 = very severe/high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 6 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by clinician on a -4 to +4 scale
Higher scores represent better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index.Positive index change values indicate that the score increased and negative values indicate that the score decreased. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 6 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. | the median of the differences in grip strength between baseline and week 6, A negative value indicates a decrease in grip strength in Kg at week 6. | Posted | Median | Inter-Quartile Range | Kilograms | 6 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group. | TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none or normal and 4 = very severe or high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) | 12 week post injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) Assessment of improvement graded by the clinician on a -4 to +4 scale
Higher scores represent better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS) | Patient Global Impression Scale-Improvement Subscale (PGIS) Assessment of improvement graded by patient on a -4 to +4 scale
Higher scores represent better outcome. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group. | QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index. Positive index change values indicate that the score increased and negative values indicate that the score decreased. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks. |
|
12 weeks
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 | Flexors Alone | 75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG001 | Flexors Plus Extensors | 150 units of abobotulinumtoxinA in flexor compartment of dominant arm (75 units in flexor carpi radialis [FCR] and 75 units in flexor carpi ulnaris [FCU]) along with placebo in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) Botulinum toxin: Botulinum injections into dominant upper extremity using protocol outlined above. Placebo: Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above | 0 | 9 | 0 | 9 | 5 | 9 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Finger Weakness | Nervous system disorders | Systematic Assessment | Weakness of fingers |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hubert H Fernandez | Cleveland Clinic Foundation | 2164451108 | FERNANH@ccf.org |
| Feb 5, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|