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Poor recruitment
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| Name | Class |
|---|---|
| Pitkin Foundation | UNKNOWN |
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This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Experimental | Anodal tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions |
|
| Sham tDCS | Sham Comparator | Sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aphasia therapy | Behavioral | Aphasia therapy using a computerized scripting program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Correct of Trained Scripts | From Baseline to up to 2 days post-training | |
| Change in Words Per Minute of Trained Scripts | From Baseline to up to 2 days post-training |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Correct of Trained Scripts | Baseline to 2 weeks and 4 weeks post-training | |
| Change in Words Per Minute of Trained Scripts | Baseline to 2 weeks and 4 weeks post-training |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Script Words Omitted | Baseline to immediate, 2 weeks, and 4 weeks post-training |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomoko Kitago, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adler Aphasia Center | Maywood | New Jersey | 07607 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Includes participants who received anodal transcranial direct current stimulation (tDCS) or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions.Since the PI left the institution and data on the cross-over assignment is not available for the 2 participants, data was reported on the collective whole and not on the treatment assignment per individual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Includes participants who received anodal transcranial direct current stimulation (tDCS) or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions. |
| 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 | Change in Percent Correct of Trained Scripts | Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution. | Posted | From Baseline to up to 2 days post-training |
|
|
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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 | All Participants | Includes participants who received anodal tDCS or sham tDCS over the left posterior language areas during aphasia therapy for 8 one-hour sessions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomoko Kitago, MD | Burke Neurological Institute | 914-368-3169 | tok7002@med.cornell.edu |
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| ID | Term |
|---|---|
| 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 |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Anodal tDCS | Device | Anodal transcranial direct current stimulation using the Chattanooga Ionto device |
|
| Sham tDCS | Device | Sham transcranial direct current stimulation using the Chattanooga Ionto device |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Primary | Change in Words Per Minute of Trained Scripts | Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution. | Posted | From Baseline to up to 2 days post-training |
|
|
| Secondary | Change in Percent Correct of Trained Scripts | Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution. | Posted | Baseline to 2 weeks and 4 weeks post-training |
|
|
| Secondary | Change in Words Per Minute of Trained Scripts | Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution. | Posted | Baseline to 2 weeks and 4 weeks post-training |
|
|
| Other Pre-specified | Change in Percent Script Words Omitted | Not Posted | Baseline to immediate, 2 weeks, and 4 weeks post-training | Participants |
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |