Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10-01126 | Other Identifier | Institutional Review Board (IRB) - NYU School of Medicine |
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
The purpose of this study is to determine whether injections of botulinum toxin (commonly known as BOTOX®) into the affected hand of Stroke patients, while targeting the muscles controlling the hand, will lead to improved use of the hand when compared to injections of placebo (a substance that looks similar to the study drug but contains no active study medication).
Hemiparesis is the most common motor impairment after stroke that frequently leads to persistent deficits in hand function. This study investigates whether the application of botulinum toxin to a set of synergistically-acting hand muscles, in conjunction with task-specific therapy, will lead to reorganization and improved motor function in the stroke-involved hand. The investigators will use objective psychophysical measures of hand function and hand function rating scales to investigate if Botox in conjunction with task-specific therapy will lead to:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin commonly known as BOTOX® | Experimental | Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. |
|
| Placebo | Placebo Comparator | Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin commonly known as BOTOX® | Drug | A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. There will be 1 treatment cycle during the 9 week study. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken to Form a Stable Grasp Pre-Treatment | Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for:
| Day 1 |
| Time Taken to Form a Stable Grasp Post Treatment |
| 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale | This scale has 3 points for each item. A zero is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.The five domains assessed by Fugl-Meyer scale are: Motor function (Maximum score in upper limb = 66; Maximum score in lower limb = 34) Sensory function (Maximum score = 24) Balance (Maximum score = 14) Range of motion of joints (Maximum score = 44) Joint pain (Maximum score = 44) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Preeti Raghavan, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Not provided
Sample size is estimated based on a treatment difference of 20% between the two groups
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin Commonly Known as BOTOX® | Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. |
| FG001 | Placebo | Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. The control group will receive a placebo injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin Commonly Known as BOTOX® | Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study. |
| 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 | Time Taken to Form a Stable Grasp Pre-Treatment | Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for:
| Improved motor execution as measured by the time taken to form a stable grasp. | Posted | Mean | Standard Error | Preload phase duration in Seconds | Day 1 |
|
90 Days
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 | Botulinum Toxin Commonly Known as BOTOX® | Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Preeti Raghavan, MD | New York University School of Medicine | 212 598 6206 | raghap01@nyumc.org |
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | The control group will receive a placebo injection. |
|
| Pre-Treatment, Day 90 |
| Disability Measured by Modified Rankin Scale Score Post-Treatment | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death). | 90 Days |
| Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment | Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully). | 1 Day and 90 Days |
| Disability Measured by Modified Rankin Scale Score Pre-Treatment | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death). | Pre-Treatment |
| BG001 | Placebo | Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Botox Group -PRE Treatment | A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. There will be 1 treatment cycle during the 9 week study. |
|
|
| Primary | Time Taken to Form a Stable Grasp Post Treatment |
| Time taken to form a stable grasp. | Posted | Mean | Standard Error | Preload phase duration in Seconds | 90 Days |
|
|
|
| Secondary | Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale | This scale has 3 points for each item. A zero is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.The five domains assessed by Fugl-Meyer scale are: Motor function (Maximum score in upper limb = 66; Maximum score in lower limb = 34) Sensory function (Maximum score = 24) Balance (Maximum score = 14) Range of motion of joints (Maximum score = 44) Joint pain (Maximum score = 44) | Total upper limb Fugl Meyer scale score out of 66. | Posted | Mean | Standard Error | Fugl Meyer Scale Score | Pre-Treatment, Day 90 |
|
|
|
| Secondary | Disability Measured by Modified Rankin Scale Score Post-Treatment | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death). | Posted | Mean | Standard Deviation | Modified Rankin Scale Score | 90 Days |
|
|
|
| Secondary | Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment | Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully). | Total upper limb Fugl Meyer Score out of 66. | Posted | Mean | Standard Error | score on a scale | 1 Day and 90 Days |
|
|
|
| Secondary | Disability Measured by Modified Rankin Scale Score Pre-Treatment | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death). | Posted | Mean | Standard Deviation | Modified Rankin Scale Score | Pre-Treatment |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received. Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand. The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |