Brain Infarction, Brain Ischemia
Conditions
Keywords
Ischemic Strokes, t DC stimulation, Functional recovery
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: 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 post-stroke seizure or history of epilepsy. 3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). 4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, 5. Stroke patients with implanted pacemakers and defibrillators. 6. Refusal to provide informed consent
Interventions
DEVICEt DC stimulation
tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.
DEVICEtDCStimulation
1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.
Sponsors
VA Office of Research and Development
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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 post-stroke seizure or history of epilepsy. 3. Patients medically unstable, demented, or terminally ill (e.g., patients with stroke as a complication of a terminal cancer). 4. On medications such as botox for spasticity or other medications known to enhance motor recovery such as d-amphetamine, 5. Stroke patients with implanted pacemakers and defibrillators. 6. Refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Functional Independence Measure (TFIM) Change Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) Change Scores | 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 | after 4 weeks of intervention | Patient discharged home or to sub-acute facility |
Countries
United States
Participant flow
Recruitment details
From 2010 to 12/2015 at the OKC VA Med Center as in-patient
Pre-assignment details
No significant events or enrolled participants were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Experimental (tDCs) t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation | 8 |
| Sham 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Experimental (tDCs) | Total | Sham |
|---|---|---|---|
| Action Research Arm Test (ARAT) | 4 units on a scale STANDARD_DEVIATION 10.9 | 2.9 units on a scale STANDARD_DEVIATION 8.1 | 1.9 units on a scale STANDARD_DEVIATION 4.2 |
| Age, Continuous | 62 Years STANDARD_DEVIATION 11 | 62 Years STANDARD_DEVIATION 9 | 63 Years STANDARD_DEVIATION 6 |
| Functional Independence Measures (TFIM) | 61 units on a scale STANDARD_DEVIATION 17 | 60 units on a scale STANDARD_DEVIATION 14 | 59 units on a scale STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Black | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 12 Participants | 5 Participants |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Total Functional Independence Measure (TFIM) Change Scores
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.
Time frame: from baseline to 4-weeks of therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental (tDCs) | Total Functional Independence Measure (TFIM) Change Scores | 22.4 units on a scale | Standard Deviation 15.7 |
| Sham | Total Functional Independence Measure (TFIM) Change Scores | 25.3 units on a scale | Standard Deviation 9.1 |
p-value: <0.05t-test, 2 sided
Secondary
Action Research Arm Test (ARAT) Change Scores
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
Time frame: baseline to after 4-weeks of therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental (tDCs) | Action Research Arm Test (ARAT) Change Scores | 10.1 units on a scale | Standard Deviation 13.5 |
| Sham | Action Research Arm Test (ARAT) Change Scores | 1.7 units on a scale | Standard Deviation 4.4 |
p-value: <0.05t-test, 2 sided
Secondary
Discharge Disposition
Patient discharged home or to sub-acute facility
Time frame: after 4 weeks of intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental (tDCs) | Discharge Disposition | Home | 4 Participants |
| Experimental (tDCs) | Discharge Disposition | Subacute Facility | 4 Participants |
| Sham | Discharge Disposition | Home | 3 Participants |
| Sham | Discharge Disposition | Subacute Facility | 5 Participants |