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| ID | Type | Description | Link |
|---|---|---|---|
| U01DC022447 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.
This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II/III design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go/no-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mA A-tDCS | Active Comparator |
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| 2 mA A-tDCS | Active Comparator |
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| S-tDCS | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York). |
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| Measure | Description | Time Frame |
|---|---|---|
| Naming | Change in the number of correctly named items between the average of the two pre-treatment Philadelphia Naming Test (PNT) assessments and the average of the two post-treatment PNT sessions at 4-weeks post treatment. | From baseline assessment to 4-weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Naming | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 1-week post treatment. | From baseline assessment to 1-week post treatment |
| Naming |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonardo Bonilha | Contact | 803-216-3469 | Leonardo.Bonilha@uscmed.sc.edu | |
| Julius Fridriksson | Contact | 803-777-5931 | fridriks@mailbox.sc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20395612 | Background | Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15. | |
| 30128538 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2026 | Jun 22, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D001039 | Aphasia, Broca |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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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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Phase II: 1 mA, 2 mA, sham; Phase III: best mA dose, sham
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To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving naming at 24-weeks post treatment.
| From baseline assessment to 24-weeks post treatment |
| Aphasia Severity | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in reducing aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ). | From baseline assessment to 4-weeks post treatment |
| Functional Communication | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving functional communication. | From baseline assessment to 4-weeks post treatment |
| Quality of Life | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving quality of life as measured by the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39). | From baseline assessment to 4-weeks post treatment |
| Communication Confidence | To demonstrate superiority of active tDCS with speech therapy compared to sham tDCS with speech therapy in improving communication confidence. | From baseline assessment to 4-weeks post treatment |
| Safety | To demonstrate safety differences (proportion of new adverse events) between groups. | From baseline assessment to 4-weeks post treatment |
| University of South Carolina | Columbia | South Carolina | 29201 | United States |
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| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| 30318184 | Background | Fridriksson J, Basilakos A, Stark BC, Rorden C, Elm J, Gottfried M, George MS, Sen S, Bonilha L. Transcranial direct current stimulation to treat aphasia: Longitudinal analysis of a randomized controlled trial. Brain Stimul. 2019 Jan-Feb;12(1):190-191. doi: 10.1016/j.brs.2018.09.016. Epub 2018 Sep 29. No abstract available. |
| 33719732 | Background | Wilmskoetter J, Fridriksson J, Basilakos A, Phillip Johnson L, Marebwa B, Rorden C, Warner G, Hickok G, Hillis AE, Bonilha L. Indirect White Matter Pathways Are Associated With Treated Naming Improvement in Aphasia. Neurorehabil Neural Repair. 2021 Apr;35(4):346-355. doi: 10.1177/1545968321999052. Epub 2021 Mar 10. |
| 38071545 | Background | Bonilha L, Rorden C, Roth R, Sen S, George MS, Fridriksson J. Improved naming in patients with Broca's aphasia with tDCS. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):273-276. doi: 10.1136/jnnp-2023-331541. |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |