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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC011739 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
| Medical University of South Carolina | OTHER |
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The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.
Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activa Dose II Real tDCS | Experimental | Actual delivery of electrical stimulation |
|
| Activa Dose II Sham tDCS | Placebo Comparator | Sham delivery of electrical stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activa Dose II Real tDCS | Device | 20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). | The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment. | Immediately post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julius Fridriksson, PhD | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States | ||
| University of South Carolina (USC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30128538 | Derived | Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287. |
| Label | URL |
|---|---|
| University of South Carolina Aphasia Laboratory | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Activa Dose II Real tDCS | Actual delivery of electrical stimulation Activa Dose II Real tDCS |
| FG001 | Activa Dose II Sham tDCS | Sham delivery of electrical stimulation Activa Dose II Sham tDCS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Activa Dose II Real tDCS | Actual delivery of electrical stimulation Activa Dose II Real tDCS |
| BG001 | Activa Dose II Sham tDCS | Sham delivery of electrical stimulation Activa Dose II Sham tDCS |
| 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 | The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). | The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment. | Posted | Mean | 95% Confidence Interval | PNT and Naming 80 score | Immediately post-treatment |
|
Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).
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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 | Activa Dose II Real tDCS | Actual delivery of electrical stimulation Activa Dose II Real tDCS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julius Fridriksson | University of South Carolina | 1-803-777-5931 | jfridrik@sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2012 | Apr 17, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 20, 2018 | Jul 31, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D003142 | Communication |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Activa Dose II Sham tDCS | Device | 20 minutes of sham stimulation per treatment day (15 total sessions) |
|
| Columbia |
| South Carolina |
| 29208 |
| United States |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Actual delivery of electrical stimulation
Activa Dose II Real tDCS
| OG001 | Activa Dose II Sham tDCS | Sham delivery of electrical stimulation Activa Dose II Sham tDCS |
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 3 |
| 34 |
| EG001 | Activa Dose II Sham tDCS | Sham delivery of electrical stimulation Activa Dose II Sham tDCS | 0 | 40 | 1 | 40 | 3 | 40 |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |