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| ID | Type | Description | Link |
|---|---|---|---|
| 1P20GM109089-01A1 | U.S. NIH Grant/Contract | View source | |
| R01DC018282 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.
Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Active cathodal tDCS + Speech-language training | Active Comparator | In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays. |
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| Comparator: Placebo cathodal tDCS + Speech-language training | Sham Comparator | In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays.. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Experimental: Active cathodal tDCS + language training | Device | Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli. Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Picture Naming of trained items | Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement | 3 months |
| Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008) | Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008) | 3 months |
| Naming Efficiency of trained items | Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Discourse informativeness - Main Concept Production | Change in discourse informativeness as measured by main concept scores; increased values indicate improvement | 3 months |
| Efficiency of discourse informativeness - Main Concept Production |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Richardson, Ph.D. | Contact | 505 277-1765 | jdrichardson@unm.edu | |
| Honey Hubbard | Contact | 505-433-7766 | hhubbard@unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Richardson, Ph.D. | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Center for Brain Recovery and Repair | Recruiting | Albuquerque | New Mexico | 87106 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2022 | Dec 12, 2022 |
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Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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| Sham Comparator: Placebo cathodal tDCS + Speech and language | Behavioral | Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. . |
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Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency
| 3 months |
| Picture Naming of untrained items - Boston Naming Test | Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement | 3 months |
| Naming Response Time of untrained items - Boston Naming Test | Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement | 3 months |
| Naming Efficiency of untrained items - Boston Naming Test | Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency | 3 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007808 | Language Therapy |
| ID | Term |
|---|---|
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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