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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Oklahoma
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Total Functional Independence Measure (TFIM) Change Scores
Study Overview
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 Description
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:
- Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- Ischemic stroke documented clinically and by neuroimaging.
- Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Unilateral, 1st acute stroke event within 4 weeks of admission to an in-patient rehabilitation facility
- •Ischemic stroke documented clinically and by neuroimaging.
- •Severe upper limb weakness (MRC grade of 2 or less at the shoulder joint)
- •Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- •Depressed patients will be included in the study (psychiatrist referral will be made if deemed necessary).
- •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.
- •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
- •Hemorrhagic strokes
- •Patient's with an episode post-stroke seizure or history of epilepsy.
- •Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer).
- •On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine,
- •Stroke patients with implanted pacemakers and defibrillators.
- •Refusal to provide informed consent
Arms & Interventions
tDC stimulation
Actual DC stimulation
Intervention: t DC stimulation (Device)
tDC stimulation
Actual DC stimulation
Intervention: tDCStimulation (Device)
t DC stimulation
Sham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects
Intervention: t DC stimulation (Device)
t DC stimulation
Sham transcranial direct current stimulation tDCS induces slight short-lasting tingling with onset of the stimulation. These sensations usually fade away in seconds. Sham interventions are essential to blind the subject and the assessor in order to obtain unbiased assessment of intervention effects
Intervention: tDCStimulation (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Action Research Arm Test (ARAT) Change Scores(baseline to after 4-weeks of therapy)
- Discharge Disposition(after 4 weeks of intervention)