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Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

Primary Purpose

Stroke, Cerebrovascular Accident, Hemiparesis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Armodafinil
Placebo
Sponsored by
Burke Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, CVA, cerebrovascular accident, hemiparesis, impairment, motor recovery, neuroplasticity, nuvigil, armodafinil

Eligibility Criteria

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

Inclusion Criteria:

  • First clinical stroke, either cerebral infarction or intracerebral hemorrhage
  • Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25
  • Screening Motricity Index score of 0-83
  • Date of stroke onset between 7 to 21 days prior to study inclusion

Exclusion Criteria:

  • Age less than 18
  • Previous clinical stroke
  • Pregnant and/or nursing patients
  • Major psychiatric history, including psychosis and history of substance abuse
  • Dementia
  • Known CNS pathology such as brain tumor
  • Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing
  • Seizures
  • Left ventricular hypertrophy (LVH)
  • Mitral valve prolapse (MVP)
  • Severe chronic renal failure or severe hepatic failure
  • History or current use of anti-epileptic medications, psychostimulants, or neuroleptics
  • Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline

Sites / Locations

  • The Burke Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Armodafinil

Placebo

Arm Description

150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score 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. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. 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)

Secondary Outcome Measures

Change in Functional Independence Measure (FIM) From Baseline to Day 100
The FIM is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires. The motor subscale includes:Eating,Grooming,BathingDressing, upper body,Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchairTransfers - toiletTransfers - bath/showerWalk/wheelchairStairs The cognition subscale includes:Comprehension ExpressionSocial interaction Problem solvingMemory Each item is scored on a 7 point ordinal scale, ranging from a score of 1(worse) to a score of 7(better). The total score for the FIM motor subscale (the sum of motor subscale ) will be a value between 13 and 91.The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5(worse outcome) & 35(best outcome).The total score for the FIM instrument (the sum of subscale scores) will be a value between 18(worse outcome) & 126 (best outcome)
Timed 3-Minute Walk Test From Baseline to Day 100
The 3MWT is a simple measure of the distance a person can walk in three minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used.A clear course such as a hallway with cones or similar to mark an approximately 15m "out and back" course[8], stopwatch, pen and paper or a device to record distance walked.
NIH Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 Score. Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
9-Hole Peg Test
9 HOLE PEG TEST Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible Participants must then remove the pegs from the holes, one by one, and replace them back into the container The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested Only the hand being evaluated should perform the test Hand not being evaluated is permitted to hold the edge of the board in order to provide stability Scores are based on the time taken to complete the test activity, recorded in seconds Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container

Full Information

First Posted
July 2, 2013
Last Updated
October 15, 2019
Sponsor
Burke Rehabilitation Hospital
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01896128
Brief Title
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Official Title
Use of a Wakefulness-Promoting Agent (Armodafinil) Combined With Neuro-rehabilitation to Improve Neurological Recovery and to Reduce the Incidence of Disability in Patients Who Suffered a Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burke Rehabilitation Hospital
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients. The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, Hemiparesis
Keywords
stroke, CVA, cerebrovascular accident, hemiparesis, impairment, motor recovery, neuroplasticity, nuvigil, armodafinil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Armodafinil
Arm Type
Experimental
Arm Description
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Other Intervention Name(s)
Nuvigil
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
inactive pill manufactured to mimic Armodafinil 150 mg tablet
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
Description
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score 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. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. 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)
Time Frame
Baseline to Day 100
Secondary Outcome Measure Information:
Title
Change in Functional Independence Measure (FIM) From Baseline to Day 100
Description
The FIM is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires. The motor subscale includes:Eating,Grooming,BathingDressing, upper body,Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchairTransfers - toiletTransfers - bath/showerWalk/wheelchairStairs The cognition subscale includes:Comprehension ExpressionSocial interaction Problem solvingMemory Each item is scored on a 7 point ordinal scale, ranging from a score of 1(worse) to a score of 7(better). The total score for the FIM motor subscale (the sum of motor subscale ) will be a value between 13 and 91.The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5(worse outcome) & 35(best outcome).The total score for the FIM instrument (the sum of subscale scores) will be a value between 18(worse outcome) & 126 (best outcome)
Time Frame
Day 100
Title
Timed 3-Minute Walk Test From Baseline to Day 100
Description
The 3MWT is a simple measure of the distance a person can walk in three minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used.A clear course such as a hallway with cones or similar to mark an approximately 15m "out and back" course[8], stopwatch, pen and paper or a device to record distance walked.
Time Frame
Day 1, Day 100
Title
NIH Stroke Scale (NIHSS)
Description
The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 Score. Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Time Frame
Baseline Day 100
Title
9-Hole Peg Test
Description
9 HOLE PEG TEST Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible Participants must then remove the pegs from the holes, one by one, and replace them back into the container The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested Only the hand being evaluated should perform the test Hand not being evaluated is permitted to hold the edge of the board in order to provide stability Scores are based on the time taken to complete the test activity, recorded in seconds Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container
Time Frame
Baseline & Day 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First clinical stroke, either cerebral infarction or intracerebral hemorrhage Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25 Screening Motricity Index score of 0-83 Date of stroke onset between 7 to 21 days prior to study inclusion Exclusion Criteria: Age less than 18 Previous clinical stroke Pregnant and/or nursing patients Major psychiatric history, including psychosis and history of substance abuse Dementia Known CNS pathology such as brain tumor Significant language dysfunction or severe neglect that hinders comprehension, participation, and barrier to testing Seizures Left ventricular hypertrophy (LVH) Mitral valve prolapse (MVP) Severe chronic renal failure or severe hepatic failure History or current use of anti-epileptic medications, psychostimulants, or neuroleptics Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal contraceptives, cyclosporine, or theophylline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pasquale Fonzetti, MD, PhD
Organizational Affiliation
The Burke Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States

12. IPD Sharing Statement

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Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

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