A Phase 2 interventional study of Armodafinil and Placebo in Stroke, Cerebrovascular Accident and Hemiparesis, sponsored by Burke Rehabilitation Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-04.
Sponsored by Burke Rehabilitation Hospital · Phase 2, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Burke Rehabilitation Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Drug: Armodafinil
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Drug: Placebo
Also known as: Nuvigil
inactive pill manufactured to mimic Armodafinil 150 mg tablet
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)
Time frame: Baseline to Day 100
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)
Time frame: Day 100
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.
Time frame: Day 1, Day 100
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
Time frame: Baseline Day 100
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
Time frame: Baseline & Day 100
| Milestone | Armodafinil | Placebo |
|---|---|---|
| Started | 8 | 11 |
| Completed | 5 | 8 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 3 | 3 |
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)
| units on a scale | Armodafinil | Placebo |
|---|---|---|
| Baseline | 14.8 ± 8.6 | 12.8 ± 7.0 |
| Day100 | 39.7 ± 15.0 | 37.8 ± 20.9 |
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)
| units on a scale | Armodafinil | Placebo |
|---|---|---|
| Baseline | 55.5 ± 17.8 | 52.4 ± 14.5 |
| Day100 | 89.2 ± 21.7 | 90.9 ± 17.4 |
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.
| feet | Armodafinil | Placebo |
|---|---|---|
| Baseline | 49.4 ± 43.5 | 152.5 ± 89.2 |
| Day100 | 152.5 ± 89.2 | 103.3 ± 73.8 |
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
| units on a scale | Armodafinil | Placebo |
|---|---|---|
| Baseline | 11.9 ± 3.9 | 13.4 ± 3.3 |
| Day100 | 6.7 ± 2.5 | 7.3 ± 2.7 |
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
| Seconds | Armodafinil | Placebo |
|---|---|---|
| Baseline | 34.0 ± 8.8 | 34.2 ± 9.5 |
| Day100 | 27.3 ± 6.7 | 29.7 ± 6.1 |
Collected over 100 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Armodafinil | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Placebo | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Armodafinil | Placebo |
|---|---|---|
| NervesousnessNervous system disorders | 1/8 | 0/11 |
Of a total 19 subjects enrolled: 8 subjects were randomly allocated to the Armodafinil arm and 11 subjects to the placebo arm. Three subjects for each arm of the study withdrew from the study. At day 100, there were 5 subjects of the Armodafinil group and 8 subjects of the placebo group that completed the study
| Age, Categorical(Participants) | Armodafinil | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 5 | 11 |
| >=65 years | 2 | 6 | 8 |
| Age, Continuous(years) | Armodafinil | Placebo | Total |
|---|---|---|---|
| Mean | 65.4 ± 12.4 | 67.5 ± 9.5 | 66.45 ± 10.95 |
| Sex: Female, Male(Participants) | Armodafinil | Placebo | Total |
|---|---|---|---|
| Female | 3 | 6 | 9 |
| Male | 5 | 5 | 10 |
| Region of Enrollment(participants) | Armodafinil | Placebo | Total |
|---|---|---|---|
| United States | 8 | 11 | 19 |
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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