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Completed

NCT Number: NCT01896128

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Armodafinil

Drug

Other names: Nuvigil

Placebo

Drug

inactive pill manufactured to mimic Armodafinil 150 mg tablet

Primary outcomes

  1. Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100

    Time frame: 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 outcomes

  1. Change in Functional Independence Measure (FIM) From Baseline to Day 100

    Time frame: 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)

  2. Timed 3-Minute Walk Test From Baseline to Day 100

    Time frame: Day 1, 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.

  3. NIH Stroke Scale (NIHSS)

    Time frame: Baseline Day 100

    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

  4. 9-Hole Peg Test

    Time frame: Baseline & Day 100

    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

Sponsors and collaborators

Lead sponsor

Burke Rehabilitation Hospital

Other

Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2013
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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