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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DC017787-01A1 | 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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Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active transcranial direct current stimulation (tDCS) paired with speech-language therapy | Experimental | Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
|
| Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy | Sham Comparator | Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active transcranial direct current stimulation (tDCS) | Device | Active transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session for 10 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Language Specific Attention Treatment Probe | Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment. | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Performance Test | Change in sustained attention as measured by mean reaction time on the Continuous Performance Test. Participants monitor a screen and press a button for all stimuli except a specific 'no-go' target. The value reported is the mean response time in milliseconds (ms) for correct 'go' trials; a decrease in time indicates improved processing speed. | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse University | Syracuse | New York | 13244 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28201833 | Background | Peach RK, Nathan MR, Beck KM. Language-Specific Attention Treatment for Aphasia: Description and Preliminary Findings. Semin Speech Lang. 2017 Feb;38(1):5-16. doi: 10.1055/s-0036-1597260. Epub 2017 Feb 15. | |
| 31348732 | Background | Peach RK, Beck KM, Gorman M, Fisher C. Clinical Outcomes Following Language-Specific Attention Treatment Versus Direct Attention Training for Aphasia: A Comparative Effectiveness Study. J Speech Lang Hear Res. 2019 Aug 15;62(8):2785-2811. doi: 10.1044/2019_JSLHR-L-18-0504. Epub 2019 Jul 25. |
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The final dataset will include self-reported demographic data (e.g., age, race, gender), medical information related to participant's stroke (e.g., date of onset, lesion location), and behavioral data obtained from cognitive and language tasks administered in the Syracuse University Aphasia Lab as part of the study. The final computerized dataset will be stripped of all personal identifiers. The investigators will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed. Data sharing will be available upon publication of the main study findings.
Starting 1 year after publication.
The investigators will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
| FG001 | Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
| 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 | Language Specific Attention Treatment Probe | Measurement of auditory comprehension for untrained sentence-level stimuli. Participants listen to a sentence and are asked to answer comprehension questions about the sentence they heard. Results are reported as the percentage of correct responses out of the total number of items administered. Higher percentages indicate better performance and less auditory comprehension impairment. | Posted | Mean | Standard Deviation | Percent | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
|
From enrollment to end of follow-up, 1 month after conclusion of treatment (10-11 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 | Active Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
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Study was started in 2021 and COVID significantly affected the ability to recruit and enroll eligible individuals in treatment. Final participant numbers were below our original targets, resulting in underpowered statistical tests.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellyn Riley | Syracuse University | 315-443-8688 | aphasia@syr.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 11, 2024 | Nov 20, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| D007802 | Language |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Sham transcranial direct current stimulation (tDCS) | Device | Sham transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session. Participants in this arm will receive sham stimulation for 10 sessions. |
|
| Language Specific Attention Treatment | Behavioral | This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this treatment. |
|
| Attention Network Test | The Attention Network Test (ANT) is a computerized task that measures the efficiency of three distinct attentional networks: Alerting, Orienting, and Executive (Conflict) control. Alerting Network Score: Calculated by subtracting the mean reaction time (RT) of double-cue trials from no-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater alerting benefit. Orienting Network Score: Calculated by subtracting the mean RT of spatial-cue trials from center-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater orienting benefit. Conflict (Executive) Network Score: Calculated by subtracting the mean RT of congruent flanker trials from incongruent flanker trials. Range: -500ms to +1000ms. Lower scores represent better executive control and less interference from distracting stimuli. | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
| Scenario Test | The Scenario Test assesses daily life communication and discourse through 6 multi-modal scenarios presented via pictures. Participants are prompted to respond to specific communicative situations. Performance is scored based on the effectiveness of communication (verbal and non-verbal) for each item. Results are reported as the average percentage of correct communicative acts out of the total possible score. Range: 0% to 100%, where higher percentages indicate better functional communication and less severe impairment. | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
| Revised Token Test | The Revised Token Test assesses auditory comprehension battery; 5 subtests were administered that contributed to the total score. Results are reported as a mean of the 5 subtest scores. Range of scores is 1 to 15, higher scores represent better performance and less severe auditory comprehension impairment. | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
| 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. |
| 31300247 | Background | Riley EA, Wu Y. Artificial grammar learning with transcranial direct current stimulation (tDCS): A pilot study. Brain Stimul. 2019 Sep-Oct;12(5):1307-1308. doi: 10.1016/j.brs.2019.07.002. Epub 2019 Jul 2. No abstract available. |
| 22524787 | Background | Petersen SE, Posner MI. The attention system of the human brain: 20 years after. Annu Rev Neurosci. 2012;35:73-89. doi: 10.1146/annurev-neuro-062111-150525. Epub 2012 Apr 12. |
| 26652115 | Background | Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22. |
| 18303984 | Background | Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098. |
| 28279641 | Background | Chhatbar PY, Chen R, Deardorff R, Dellenbach B, Kautz SA, George MS, Feng W. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Brain Stimul. 2017 May-Jun;10(3):553-559. doi: 10.1016/j.brs.2017.02.007. Epub 2017 Feb 27. |
| 11970796 | Background | Fan J, McCandliss BD, Sommer T, Raz A, Posner MI. Testing the efficiency and independence of attentional networks. J Cogn Neurosci. 2002 Apr 1;14(3):340-7. doi: 10.1162/089892902317361886. |
| 26645310 | Background | Ishigami Y, Eskes GA, Tyndall AV, Longman RS, Drogos LL, Poulin MJ. The Attention Network Test-Interaction (ANT-I): reliability and validity in healthy older adults. Exp Brain Res. 2016 Mar;234(3):815-27. doi: 10.1007/s00221-015-4493-4. Epub 2015 Dec 8. |
| 27372845 | Background | Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15. |
| BG001 | Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Western Aphasia Battery-Revised | Overall score from the Western Aphasia Battery-Revised, also known as the Aphasia Quotient score. Scores from 0-100, higher is less severe. | Mean | Standard Deviation | Raw score |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. |
|
|
| Secondary | Continuous Performance Test | Change in sustained attention as measured by mean reaction time on the Continuous Performance Test. Participants monitor a screen and press a button for all stimuli except a specific 'no-go' target. The value reported is the mean response time in milliseconds (ms) for correct 'go' trials; a decrease in time indicates improved processing speed. | Posted | Mean | Standard Deviation | ms | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
|
|
|
| Secondary | Attention Network Test | The Attention Network Test (ANT) is a computerized task that measures the efficiency of three distinct attentional networks: Alerting, Orienting, and Executive (Conflict) control. Alerting Network Score: Calculated by subtracting the mean reaction time (RT) of double-cue trials from no-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater alerting benefit. Orienting Network Score: Calculated by subtracting the mean RT of spatial-cue trials from center-cue trials. Range: -500ms to +500ms. Higher positive scores represent a greater orienting benefit. Conflict (Executive) Network Score: Calculated by subtracting the mean RT of congruent flanker trials from incongruent flanker trials. Range: -500ms to +1000ms. Lower scores represent better executive control and less interference from distracting stimuli. | Posted | Mean | Standard Deviation | ms | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
|
|
|
| Secondary | Scenario Test | The Scenario Test assesses daily life communication and discourse through 6 multi-modal scenarios presented via pictures. Participants are prompted to respond to specific communicative situations. Performance is scored based on the effectiveness of communication (verbal and non-verbal) for each item. Results are reported as the average percentage of correct communicative acts out of the total possible score. Range: 0% to 100%, where higher percentages indicate better functional communication and less severe impairment. | Posted | Mean | Standard Deviation | Percent | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
|
|
|
| Secondary | Revised Token Test | The Revised Token Test assesses auditory comprehension battery; 5 subtests were administered that contributed to the total score. Results are reported as a mean of the 5 subtest scores. Range of scores is 1 to 15, higher scores represent better performance and less severe auditory comprehension impairment. | Posted | Mean | Standard Deviation | Scaled score | Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Sham Transcranial Direct Current Stimulation (tDCS) Paired With Speech-language Therapy | Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week. | 0 | 11 | 0 | 11 | 0 | 11 |
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| 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 |
| D003142 | Communication |
| D001519 | Behavior |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| Follow-up |
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| Alerting, follow-up |
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| Orienting, pre-treatment |
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| Orienting, post-treatment |
|
| Orienting, follow-up |
|
| Conflict, pre-treatment |
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| Conflict, post-treatment |
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| Conflict, follow-up |
|
| Follow-up |
|
| 1-month Follow-up |
|