Comparison of Botulinum Toxin Injections in Forearm FLexor Plus EXtensor Muscles vs. Flexor Muscles Alone for Treatment of Essential Hand Tremor(FLEX-D ET)
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 150 units of abobotulinumtoxinA 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) |
Drug: Botulinum toxin
Botulinum injections into dominant upper extremity using protocol outlined above.
Other Names:
Other: Placebo
Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above
|
| Experimental: 75 units of abobotulinumtoxinA 75 units of abobotulinumtoxinA in FCR and FCU and 25 units in ECR and ECU |
Drug: Botulinum toxin
Botulinum injections into dominant upper extremity using protocol outlined above.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. [6 weeks]
6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome.
Secondary Outcome Measures
- Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. [Baseline and 6 weeks]
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.
- Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. [6 weeks]
6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by clinician on a -4 to +4 scale -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome.
- 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. [Baseline and 6 weeks]
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.
- Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. [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.
- 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group. [12 weeks]
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 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) [12 weeks]
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 -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome.
- 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS) [12 weeks]
Patient Global Impression Scale-Improvement Subscale (PGIS) Assessment of improvement graded by patient on a -4 to +4 scale -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome.
- 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. [Baseline and 12 weeks.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 and over, male or female patient with (ET) involving at least their dominant hand, as diagnosed by a movement disorders neurologist.
-
Having bothersome hand tremor in dominant hand with a hand TRS ≥2
-
On stable medications during last 30 days prior to enrollment.
Exclusion Criteria:
-
Presence of secondary causes of tremor, such as dystonia and parkinsonism
-
Any contraindication to botulinum toxin injections (e.g. motor neuron disease, neuromuscular junction disease, etc.)
-
History of surgical treatment for (ET).
-
Dementia as defined by DSM-V criteria
-
Patients with suboptimally treated depression and significant depressive symptoms as defined by a PHQ-9 score of ≥15 (PHQ-9 scores 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression). Antidepressant medications, prescribed for depression or anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
-
Patients with suboptimally treated anxiety and significant anxiety symptoms as defined by a GAD-7 score of ≥15 (GAD-7 scores 0-4: minimal anxiety; 5-9: mild anxiety; 10-14: moderate anxiety; 15-21: severe anxiety). Anti-anxiety medications, prescribed for anxiety, will be allowed if the patient has been on a stable dose for at least 30 days.
-
Significant renal, hepatic, cardiac and thyroid disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Hubert Fernandez, MD, The Cleveland Clinic
Study Documents (Full-Text)
More Information
Publications
None provided.- 15-1519
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| COMPLETED | 10 | 9 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 | Total of all reporting groups |
| Overall Participants | 10 | 9 | 19 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
73.1
(12.0)
|
64.9
(9.1)
|
69.2
(11.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
50%
|
5
55.6%
|
10
52.6%
|
| Male |
5
50%
|
4
44.4%
|
9
47.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
10%
|
0
0%
|
1
5.3%
|
| White |
9
90%
|
9
100%
|
18
94.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Right-handed (participants) [Number] | |||
| Number [participants] |
9
90%
|
7
77.8%
|
16
84.2%
|
| TRS mean (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
12.9
(4.6)
|
11.3
(4.1)
|
12.1
(4.3)
|
| QUEST Health status self-report, med(IQR) (units on a scale) [Mean (Inter-Quartile Range) ] | |||
| Mean (Inter-Quartile Range) [units on a scale] |
82.5
|
82.5
|
82.5
|
| QUEST Quality of Life self-report, mean(SD) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
84
(9.7)
|
82.8
(6.7)
|
83.4
(8.2)
|
| QUEST Communication, med (IQR) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
| QUEST Work, med (IQR) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
0
|
8.3
|
0
|
| QUEST Hobbies, med (IQR) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
0
|
0
|
0
|
| QUEST Physical, med (IQR) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
44.4
|
61.1
|
61.1
|
| QUEST Psychosocial, med (IQR) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
8.3
|
25
|
11.1
|
| QUEST Summary Index, med (IQR) (units on a scale) [Mean (Inter-Quartile Range) ] | |||
| Mean (Inter-Quartile Range) [units on a scale] |
12.2
|
26.4
|
17.8
|
| PHQ-9, med (IQR) (units on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [units on a scale] |
0.5
|
4
|
2
|
| GAD-7, med (IQR) (Score on a scale) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [Score on a scale] |
0
|
2
|
0
|
| Age of onset, med (IQR) (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
55.5
|
58
|
58
|
| Disease duration, med (IQR) (Years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [Years] |
5.5
|
5
|
5
|
| Main Grip Strength (Kg) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [Kg] |
30.8
|
28
|
29.7
|
Outcome Measures
| Title | Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups. |
|---|---|
| Description | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by the patient on a -4 to +4 scale -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
1.2
|
2.2
|
| Title | Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups. |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
-5
|
-5
|
| Title | Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups. |
|---|---|
| Description | 6 weeks post injection Clinician Global Impression if improvement Scale (CGIS) Assessment of improvement graded by clinician on a -4 to +4 scale -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
1
|
3
|
| Title | 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. |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
1.1
|
-5.3
|
| Title | Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks. |
|---|---|
| Description | 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. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [Kilograms] |
-6.2
|
-11
|
| Title | 12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group. |
|---|---|
| Description | 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. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
6
|
6
|
| Title | 12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS) |
|---|---|
| Description | 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 -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
3
|
3
|
| Title | 12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS) |
|---|---|
| Description | Patient Global Impression Scale-Improvement Subscale (PGIS) Assessment of improvement graded by patient on a -4 to +4 scale -4 = severe worsening 0 = no change +4 = complete abolishment of symptoms Higher scores represent better outcome. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
1
|
3
|
| Title | 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. |
|---|---|
| Description | 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. |
| Time Frame | Baseline and 12 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors |
|---|---|---|
| Arm/Group Description | 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. | 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 |
| Measure Participants | 10 | 9 |
| Median (Inter-Quartile Range) [score on a scale] |
-1.67
|
0
|
Adverse Events
| Time Frame | 12 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Flexors Alone | Flexors Plus Extensors | ||
| Arm/Group Description | 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. | 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 | ||
All Cause Mortality |
||||
| Flexors Alone | Flexors Plus Extensors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/9 (0%) | ||
Serious Adverse Events |
||||
| Flexors Alone | Flexors Plus Extensors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Flexors Alone | Flexors Plus Extensors | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/10 (40%) | 5/9 (55.6%) | ||
| Nervous system disorders | ||||
| Finger Weakness | 4/10 (40%) | 5/9 (55.6%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Hubert H Fernandez |
|---|---|
| Organization | Cleveland Clinic Foundation |
| Phone | 2164451108 |
| FERNANH@ccf.org |
- 15-1519