- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04963803
Improving Aphasia Using Electrical Brain Stimulation
Improving Aphasia Outcomes Through tDCS-Mediated Attention Management
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Syracuse, New York, United States, 13244
- Syracuse University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older.
- No diagnosis of neurological disorder (other than stroke).
- No diagnosis of psychiatric disorder.
- No seizure within the past 6 months.
- Not pregnant.
- In chronic phase of recovery, defined as at least 6 months post-stroke.
- Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
- No metal implants in the head.
- No unhealed skull fractures.
- Onset of aphasia related to left hemisphere stroke.
- Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
- Mild to moderate aphasia.
- Cognitive ability minimally within functional limits.
- Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids).
- Willing to allow audio-recording of study sessions.
Exclusion Criteria:
- Younger than 18 years old.
- Diagnosis or history of neurological disorder other than stroke.
- Diagnosis or history of psychiatric disorder.
- History of seizures within the past 6 months.
- Pregnant.
- <6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study)
- Currently undergoing speech and language therapy targeting auditory comprehension or attention.
- Metal implants in the head.
- Currently has a skull fracture.
- Onset of aphasia related to etiology other than left hemisphere stroke.
- Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex.
- No aphasia or severe aphasia.
- Cognitive ability below functional limits.
- Unable to pass vision and/or hearing screening with use of corrective aids.
- Unwilling to allow audio-recording of study sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
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.
|
|
Sham Comparator: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Language Specific Attention Treatment Probe
Time Frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continuous Performance Test
Time Frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline
|
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
|
|
Attention Network Test
Time Frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline
|
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
Time Frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline
|
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
Time Frame: Pre-treatment: Baseline measure collected before treatment; Post-treatment: 5-6 weeks after baseline; Follow-up: 10-11 weeks after baseline
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Language Disorders
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Communication
- Stroke
- Aphasia
- Communication Disorders
- Language
Other Study ID Numbers
- 1R21DC017787-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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