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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD050267 | U.S. NIH Grant/Contract | View source |
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Funding limit reached due to slower then anticipated recruitment.
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS and occupational therapy | Experimental | 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
|
| Sham and occupational therapy | Sham Comparator | Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | 2 weeks |
| Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | 3 months |
| Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | 1 year after stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks. The score is the average of the scores calculated from "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Pain Scale | during therapy | |
| Mini Mental Status Scale | Mini Mental Status Scale is a test of cognitive function; it includes tests of orientation, attention, memory, language and visual-spatial skills, scored 0-30, the higher scores mean the better performance. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16490258 | Background | Hidler J, Hodics T, Xu B, Dobkin B, Cohen LG. MR compatible force sensing system for real-time monitoring of wrist moments during fMRI testing. J Neurosci Methods. 2006 Sep 15;155(2):300-7. doi: 10.1016/j.jneumeth.2006.01.016. Epub 2006 Feb 21. | |
| 22579647 | Background | Hodics TM, Nakatsuka K, Upreti B, Alex A, Smith PS, Pezzullo JC. Wolf Motor Function Test for characterizing moderate to severe hemiparesis in stroke patients. Arch Phys Med Rehabil. 2012 Nov;93(11):1963-7. doi: 10.1016/j.apmr.2012.05.002. Epub 2012 May 10. |
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Enrolled participants were assigned to groups unless they were found to meet one of the exclusion criteria, or withdrew their consent.
UT SOuthwestern Hospitals, rehabilitation and stroke clinics were screened for eligible stroke patients from 2009 through 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS and Occupational Therapy | 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
| FG001 | Sham and Occupational Therapy | Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
| FG002 | fMRI Control Group no Intervention | Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.The purpose of this study subgroup was to set up and test the complex MRI and TMS protocol developed for this project. |
| FG003 | tDCS and no Arm Movement | 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
| FG004 | Sham and no Arm Movement | Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One subject who did not meet enrollment criteria was erroneously enrolled and was removed by PI from the study immediately after enrollment, prior to randomization. Therefore the total number of enrolled is one more then randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS and Occupational Therapy | 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
1 year, the entire time of follow-up.
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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 | tDCS and Occupational Therapy | 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| recurrent stroke | Nervous system disorders | Systematic Assessment | Patient developed bilateral strokes prior to starting therapy, therefore patient was discontinued from study after randomization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| phosphene phenomenon | Nervous system disorders | Systematic Assessment | Resolved with changing the electrode pads. Expected event. |
Slow recruitment and termination before pre-specified number of subjects recruited, attrition due to being lost to follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timea Hodics, M.D. | University of Texas Southwestern | Timea.Hodics@UTSouthwestern.edu |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Sham tDCS | Device | Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
|
| 3 months |
| 3 months |
| NIHSS | The National Institutes of Health Stroke Scale (NIHSS) provides a quantitative measure of stroke-related neurologic deficit. The NIHSS was originally designed as a research tool to measure baseline data on patients in acute stroke clinical trials. The score ranges 0-42, a score of 0 represents no deficit, lower score is better. | 3 months |
| Beck Depression Inventory | 21-item, self-rated scale that evaluates key symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity. | 3 months |
| Ashworth Spasticity Scale | 3 months |
| Abilhand Questionnaire | 3 months |
| Motor Activity Log | 3 months |
| fMRI Overactivation in Motor Cortex: Voxel Count and Intensity | 3 months |
| Barthel Index | The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living. Ten variables describing activities of daily living and mobility are scored. The total score ranges 0-100, a higher number being a reflection of greater ability to function independently following hospital discharge. | 3 months |
| Medical Research Council (MRC) Scale | The muscle scale grades muscle strength on a scale of 0 to 5 in relation to the maximum expected for that muscle. The patient's effort is graded on a scale of 0 (no movement) -5 (muscle contracts normally against full resistance). | 3 months |
| 35925037 | Derived | Hodics T, Cohen LG, Pezzullo JC, Kowalske K, Dromerick AW. Barriers to Enrollment in Post-Stroke Brain Stimulation in a Racially and Ethnically Diverse Population. Neurorehabil Neural Repair. 2022 Sep;36(9):596-602. doi: 10.1177/15459683221088861. Epub 2022 Aug 4. |
| 33175411 | Derived | Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. |
| Sham and Occupational Therapy |
Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
| BG002 | fMRI Control Group no Intervention | Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed. |
| BG003 | tDCS and no Arm Movement | 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
| BG004 | Sham and no Arm Movement | Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Sham and Occupational Therapy |
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
| OG002 | tDCS and no Arm Movement | 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. |
| OG003 | Sham and no Arm Movement | Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. |
|
|
| Primary | Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Primary | Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | All subjects with outcome data at the prespecified follow-up timepoint were included. | Posted | Mean | Standard Deviation | units on a scale | 1 year after stroke |
|
|
|
| Secondary | Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks. The score is the average of the scores calculated from "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.) | All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Other Pre-specified | Visual Analog Pain Scale | Not Posted | during therapy | Participants |
| Other Pre-specified | Mini Mental Status Scale | Mini Mental Status Scale is a test of cognitive function; it includes tests of orientation, attention, memory, language and visual-spatial skills, scored 0-30, the higher scores mean the better performance. | fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Other Pre-specified | NIHSS | The National Institutes of Health Stroke Scale (NIHSS) provides a quantitative measure of stroke-related neurologic deficit. The NIHSS was originally designed as a research tool to measure baseline data on patients in acute stroke clinical trials. The score ranges 0-42, a score of 0 represents no deficit, lower score is better. | All available data from participants was included at the 3 months follow-up. fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Other Pre-specified | Beck Depression Inventory | 21-item, self-rated scale that evaluates key symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity. | All participants with available measurement were included. fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Other Pre-specified | Ashworth Spasticity Scale | Not Posted | 3 months | Participants |
| Other Pre-specified | Abilhand Questionnaire | Not Posted | 3 months | Participants |
| Other Pre-specified | Motor Activity Log | Not Posted | 3 months | Participants |
| Other Pre-specified | fMRI Overactivation in Motor Cortex: Voxel Count and Intensity | Not Posted | 3 months | Participants |
| Other Pre-specified | Barthel Index | The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living. Ten variables describing activities of daily living and mobility are scored. The total score ranges 0-100, a higher number being a reflection of greater ability to function independently following hospital discharge. | All participants with available data were included. fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Other Pre-specified | Medical Research Council (MRC) Scale | The muscle scale grades muscle strength on a scale of 0 to 5 in relation to the maximum expected for that muscle. The patient's effort is graded on a scale of 0 (no movement) -5 (muscle contracts normally against full resistance). | Not Posted | 3 months | Participants |
| 1 |
| 19 |
| 2 |
| 19 |
| 9 |
| 19 |
| EG001 | Sham and Occupational Therapy | Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. | 0 | 17 | 2 | 17 | 3 | 17 |
| EG002 | fMRI Control Group no Intervention | Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | tDCS and no Arm Movement | 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Sham and no Arm Movement | Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. | 0 | 4 | 0 | 4 | 0 | 4 |
|
| death | Infections and infestations | Systematic Assessment | Patient succumbed to pneumonia two months after completing therapy. |
|
| mental status change hospitalisation | Nervous system disorders | Systematic Assessment | Patient had two episodes of loss of consciousness, no stroke or seizure 1 year after treatment |
|
| hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient fell and suffered two successive hip fractures almost a year after treatment. |
|
|
| itching or tingtling under the electrode | Product Issues | Systematic Assessment | Expected event, was generally mild and resolved spontaneously within minutes. |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment | Expected event, resolved spontaneously |
|
| sleepiness | Nervous system disorders | Systematic Assessment | No treatment was given to this subject, as patient was too sleepy for participation. After 3 consecutive days of inability to perform treatment patient was discontinued from study according to protocol. |
|
| car accident | Skin and subcutaneous tissue disorders | Systematic Assessment | Only bruising, not requiring hospitalisation approx 3 months from treatment. |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |