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| ID | Type | Description | Link |
|---|---|---|---|
| STU 012014-028 | Other Identifier | IRB University of Texas Southwestern Medical Center |
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Due to administrative difficulties caused by PI change.
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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This study will evaluate the feasibility of dual tDCS to improve arm motor function in chronic stroke patients. In addition it will collect pilot data on the blood biomarkers associated with treatment effect.
The proposed, increased intensity dtDCS is a new, economical, noninvasive stimulation approach that has the potential for large-scale clinical application. Dual tDCS, in conjunction with physical and occupational therapy, is not only more effective in enhancing motor performance and cortical plasticity compared to sham, but approximately 50% more effective than cathodal or anodal stimulation in healthy subjects and after stroke. However, it will only be clinically useful and important if the beneficial effects persist over time in a wider stroke patient population. Improvement in inter-hemispheric balance, through an activation shift toward the affected hemisphere and clinical improvement in response to tDCS has been reported previously in small studies. Hemorrhagic stroke patients have not been evaluated.
The investigators will study rehabilitation associated cortical plasticity at a cellular level to gain insight into the neural substrates underlying the clinical improvement. There are no prior studies investigating the potential of VEGF polymorphisms to contribute to rehabilitative treatment-induced functional recovery in humans. The investigators expect that patients with VEGF genotype 2578A/A will recover less then subjects without this polymorphism. Since in animal models VEGF and BDNF have a complimentary role, VEGF polymorphism may explain some of the variability in strength of association between BDNF polymorphism Val66Met and recovery. This novel pilot study measures both the genetic and physiologic expression of multiple growth factors - before and after a promising new therapy regimen - to better understand the contribution of growth factors to long-term plasticity and functional recovery. If VEGF serum levels elevate with clinical improvement, then this may identify a new indicator of treatment efficacy that can be collected noninvasively and with little cost. The results will provide guidance for new inclusion/exclusion criteria for clinical studies based on genetic markers, as well as uncover the potential for new therapeutic strategies to enhance treatment efficacy by augmenting VEGF during rehabilitation with FDA-approved strategies currently in clinical trials for other conditions (NIH Clinical Trials Registry: NCT01384162, NCT00620217, and NCT00744315).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dTDCS plus physical therapy | Experimental | active dual transcranial direct current stimulation (TDCS) arm (M1-M1) |
|
| Sham dTDCS plus physical therapy | Placebo Comparator | Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual transcranial direct current stimulation | Device | Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | any adverse events that might be related to study procedures | enrollment to 3 month followup |
| Upper Extremity Fugl-Meyer Score | Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully). | change between before and 3 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | Timed performance of 15 functional upper extremity tasks, 0-120 seconds, and 2 strength measures. WMFT time measurements are calculated as the arithmetic mean of rate of performance, where we calculate "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". Therefore the results have a minimum score of 0, where the subject could not perform any of the tasks, and no pre-defined maximum score, the higher the rate score the faster the subject was able to perform the tasks. ( see Hodics et al.,2013) |
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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 |
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3 subjects were found not eligible for participation after signing consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | dTDCS Plus Physical Therapy | active dual transcranial direct current stimulation (TDCS) arm (M1-M1) dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. |
| FG001 | Sham dTDCS Plus Physical Therapy | Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | dTDCS Plus Physical Therapy | active dual transcranial direct current stimulation (TDCS) arm (M1-M1) dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. |
| 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 | Adverse Events | any adverse events that might be related to study procedures | Posted | Number | number of events | enrollment to 3 month followup |
|
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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 | dTDCS Plus Physical Therapy | active dual transcranial direct current stimulation (TDCS) arm (M1-M1) dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. |
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Early termination due to PI relocation, low recruitment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timea Hodics, M.D. | UTSW | (240)-423-2741 | Timea.Hodics@UTSouthwestern.edu |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| change between before and at 3 months follow-up |
| Sham dTDCS Plus Physical Therapy |
Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Upper Extremity Fugl-Meyer Score | Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully). | One subject finished the treatment, statistical analysis was not performed | Posted | change between before and 3 months follow-up |
|
|
| Secondary | Wolf Motor Function Test | Timed performance of 15 functional upper extremity tasks, 0-120 seconds, and 2 strength measures. WMFT time measurements are calculated as the arithmetic mean of rate of performance, where we calculate "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". Therefore the results have a minimum score of 0, where the subject could not perform any of the tasks, and no pre-defined maximum score, the higher the rate score the faster the subject was able to perform the tasks. ( see Hodics et al.,2013) | One subject finished the treatment, statistical analysis was not performed | Posted | change between before and at 3 months follow-up |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Sham dTDCS Plus Physical Therapy | Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used. dual transcranial direct current stimulation: Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |