Clinical Trial: Transcranial Direct Current Stimulation, Improve Functional Motor Recovery, Affected Arm

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Does Transcranial Direct Current Stimulation Improve Functional Motor Recovery in the Affected Arm-Hand in Patients After an Acute Ischemic Stroke: A Randomized Control Trial

Brief Summary: Overall goal of this study is to determine if transcranial direct current stimulation (tDCS) plus conventional occupational therapy improves functional motor recovery in the affected arm-hand in patients after an acute ischemic stroke compared to sham tDCS plus conventional occupational therapy, and to obtain information to plan a large randomized controlled trial.

Detailed Summary:

Study design:

Patients Successive admissions to the stroke service of the Veterans Affairs Medical Center with ischemic strokes will participate in this study.

Eligibility criteria:

Inclusion criteria:

  1. Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
  2. Ischemic stroke documented clinically and by neuroimaging.
  3. Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
  4. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
  5. Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
  6. Aphasic alert patients will be included in the study provided they were able to follow simple directions by verbal or gestural cues and provided with a written informed consent.
  7. Informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21). When it is not possible for the patient to provide informed consent or patient is cognitively impaired with MMSE ≤ 20, proxy consent will be obtained from the next of kin (legal authorized representative) according to institutional IRB standards. Informed consent will be obtained by the admitting physicians.

Exclusion criteria:

  1. Hemorrhagic strokes
  2. Patient's with an episode
    Sponsor: University of Oklahoma

    Current Primary Outcome: Total Functional Independence Measure (TFIM) Change Scores [ Time Frame: from baseline to 4-weeks of therapy ]

    The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.


    Original Primary Outcome: total Functional Independence Measure (TFIM) [ Time Frame: after 4-weeks of therapy ]

    The Functional Independence Measure (FIM™) will measure the degree of disability. The FIM scale is a reliable and valid functional assessment measure widely used in rehabilitation settings. The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. A FIM™ item score of seven is categorized as "complete independence," while a score of one is "total assist" (patient performs less than 25% of task). The total FIM score (TFIM) quantifies level of independence and ranges from 18 (lowest) to 126 (highest) level of independence.


    Current Secondary Outcome:

    • Action Research Arm Test (ARAT) Change Scores [ Time Frame: baseline to after 4-weeks of therapy ]
      The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually. Score 0=no arm-hand movement and 57=normal
    • Discharge Disposition [ Time Frame: after 4 weeks of intervention ]
      Patient discharged home or to sub-acute facility


    Original Secondary Outcome: Action Research Arm Test (ARAT) [ Time Frame: after 4-weeks of therapy ]

    The Action Research Arm Test (ARAT) is a standardized ordinal scale that measures upper extremity (arm and hand) function. This test assesses the ability to lift various sized objects to a height of 14.75 inches, move cylindrical shaped objects a distance of 14.75 inches, use pinch grasp to lift varying sized objects (such as a ball bearing, and a marble) between the thumb and the 3rd finger, and perform 3 gross upper extremity movements. Each upper extremity is evaluated individually


    Information By: University of Oklahoma

    Dates:
    Date Received: September 7, 2010
    Date Started: September 16, 2010
    Date Completion:
    Last Updated: March 29, 2017
    Last Verified: March 2017