Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R44NS092144 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Georgetown University | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Definition tDCS (Active) | Experimental |
| |
| High-Definition tDCS (Sham) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD-tDCS (Soterix Medical, Active) | Device | Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke | The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Determine alternate outcome measures | Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes. | 4 weeks and 6 months follow up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abhishek Datta, Ph.D | Soterix Medical Inc. | Study Chair |
| Lucas C Parra, Ph.D | City University of New York - CCNY | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.) | Washington D.C. | District of Columbia | 20057 | United States | ||
Not provided
| Label | URL |
|---|---|
| Feasibility of using high-definition transcranial direct current stimulation (HD-tDCS) to enhance treatment outcomes in persons with aphasia. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000849 | Anomia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| The City College of New York |
| OTHER |
| Medstar Health Research Institute | OTHER |
| University of South Carolina | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| HD-tDCS (Soterix Medical, Sham) | Device | Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets. |
|
|
| University of North Carolina School of Medicine (Adam Jacks, Ph.D.) |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |