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Slow accrual over 6 year period
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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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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.
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:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| t DC stimulation | Sham Comparator | 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 |
|
| tDC stimulation | Experimental | Actual DC stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| t DC stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to 4-weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meheroz H Rabadi, MD, MRCPI | Oklahoma University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma City VA Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
No significant events or enrolled participants were excluded.
From 2010 to 12/2015 at the OKC VA Med Center as in-patient
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental (tDCs) | t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation |
| FG001 | Sham | 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental (tDCs) | t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation |
| BG001 | Sham | 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | from baseline to 4-weeks of therapy |
|
3-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental (tDCs) | t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meheroz H. Rabadi | OKC VA Medical Center | 405-456-5298 | meheroz.rabadi@va.gov |
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| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| tDCStimulation | Device | 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. |
|
|
| baseline to after 4-weeks of therapy |
| Discharge Disposition | Patient discharged home or to sub-acute facility | after 4 weeks of intervention |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Action Research Arm Test (ARAT) | Action Research Arm Test (ARAT), a standardized ordinal scale that measures UE function. 23 ARAT is based on the assumption that complex UE movements used in daily life can be explained and assessed by 4 basic movements: grasp, grip, pinch and gross movements of extension and flexion at the elbow and shoulder (Appendix 1). The ARAT is graded on a 4-point scale (0 is worse and 57 points is normal). ARAT scoring was undertaken as per instructions. | Mean | Standard Deviation | units on a scale |
|
| Functional Independence Measures (TFIM) | The FIM has 18 items and each item is scored on an ordinal scale ranging from 1 to 7. The total FIM score (TFIM) quantifies level of independence and ranges from 18 (total dependence) to 126 (total independence) | Mean | Standard Deviation | units on a scale |
|
| Sham |
8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes. |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | baseline to after 4-weeks of therapy |
|
|
|
|
| Secondary | Discharge Disposition | Patient discharged home or to sub-acute facility | Posted | Count of Participants | Participants | after 4 weeks of intervention |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Sham | 8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |