StrokeNCT04166513
Effects of Transcranial Direct Current Stimulation (tDCS) on Language
A study testing Targeted Transcranial Direct Current Stimulation, Phonologic-Focused Speech Therapy and Semantic-Focused Speech Therapy in people with Stroke and Aphasia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Targeted Transcranial Direct Current Stimulation, Phonologic-Focused Speech Therapy and Semantic-Focused Speech Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor).
- Patients must be adults and have English-language fluency.
- Patients must be eligible to undergo MRI.
Who cannot join
- Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)
- Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
- No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
- Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, and inability to see or hear stimulus materials
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Effects of tDCS in Language Recovery and Reorganization in Chronic Aphasia
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.
Read the detailed description
Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).
This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.
Study design:
Patients will be randomly assigned to one of 2 speech therapy groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.
- Being tested
- Targeted Transcranial Direct Current Stimulation, Active Control Transcranial Direct Current Stimulation, Phonologic-Focused Speech Therapy, Semantic-Focused Speech Therapy
- Keywords
- tDCS, treatment, brain stimulation
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Transcranial Direct Current StimulationDevice
Also called HD-tDCS, tDCS
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region.
Active Control Transcranial Direct Current StimulationDevice
Also called Active Control tDCS, Active Control HD-tDCS
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region.
Phonologic-Focused Speech TherapyBehavioural
Also called Phonologic Component Analysis
Participants are asked to generate or choose from a list phonologic information about a target picture.
Semantic-Focused Speech TherapyBehavioural
Also called Semantic Feature Analysis
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
| Study group | Role | What they receive |
|---|---|---|
| Targeted tDCS with Phonologic-Focused Speech Therapy | Experimental | Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before. Receives: Device: Targeted Transcranial Direct Current Stimulation; Behavioral: Phonologic-Focused Speech Therapy |
| Active Control tDCS with Phonologic-Focused Speech Therapy | Active comparator | Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions. Receives: Device: Active Control Transcranial Direct Current Stimulation; Behavioral: Phonologic-Focused Speech Therapy |
| Targeted tDCS with Semantic-Focused Speech Therapy | Experimental | Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions. Receives: Device: Targeted Transcranial Direct Current Stimulation; Behavioral: Semantic-Focused Speech Therapy |
| Active Control tDCS with Semantic-Focused Speech Therapy | Active comparator | Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions. Receives: Device: Active Control Transcranial Direct Current Stimulation; Behavioral: Semantic-Focused Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct).
There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs.
Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second
Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A.
Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.
Measured: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Secondary outcomes (3)
fMRI- Baseline
Number of participants completing Rs-fMRI before therapy.
Measured: Baseline
fMRI After Cycle A
Number of participants completing Rs-fMRI after Cycle A therapy.
Measured: 10-weeks post Cycle A
fMRI Post Cycle B
Number of participants completing fMRI post Cycle B
Measured: 10 weeks post cycle B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start13 Dec 2019
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from targeted to active control stimulation (or vice versa).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Pillay, Medical College of Wisconsin
- Investigators
- Sara Pillay, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166513
- Sponsor's protocol ID
- 33162
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2019
- Last updated
- 3 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jordan LC, Hillis AE. Disorders of speech and language: aphasia, apraxia and dysarthria. Curr Opin Neurol. 2006 Dec;19(6):580-5. doi: 10.1097/WCO.0b013e3280109260.
PubMed 17102697Greener J, Enderby P, Whurr R. Pharmacological treatment for aphasia following stroke. Cochrane Database Syst Rev. 2001;2001(4):CD000424. doi: 10.1002/14651858.CD000424.
PubMed 11687079Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
PubMed 22592672Lincoln NB, McGuirk E, Mulley GP, Lendrem W, Jones AC, Mitchell JR. Effectiveness of speech therapy for aphasic stroke patients. A randomised controlled trial. Lancet. 1984 Jun 2;1(8388):1197-200. doi: 10.1016/s0140-6736(84)91690-8.
PubMed 6202993Ellis C, Simpson AN, Bonilha H, Mauldin PD, Simpson KN. The one-year attributable cost of poststroke aphasia. Stroke. 2012 May;43(5):1429-31. doi: 10.1161/STROKEAHA.111.647339. Epub 2012 Feb 16.
PubMed 22343643Ellis C, Dismuke C, Edwards KK. Longitudinal trends in aphasia in the United States. NeuroRehabilitation. 2010;27(4):327-33. doi: 10.3233/NRE-2010-0616.
PubMed 21160122Boysen AE, Wertz RT. Clinician Costs in Aphasia Treatment: How Much Is a Word Worth? Clin. Aphasiology 1996;24:207-213.
Meinzer M, Djundja D, Barthel G, Elbert T, Rockstroh B. Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy. Stroke. 2005 Jul;36(7):1462-6. doi: 10.1161/01.STR.0000169941.29831.2a. Epub 2005 Jun 9.
PubMed 15947279Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.
PubMed 23060684Paulus W. Transcranial direct current stimulation (tDCS). Suppl Clin Neurophysiol. 2003;56:249-54. doi: 10.1016/s1567-424x(09)70229-6.
PubMed 14677402Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
PubMed 10990547Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
PubMed 11723286Liebetanz D, Nitsche MA, Tergau F, Paulus W. Pharmacological approach to the mechanisms of transcranial DC-stimulation-induced after-effects of human motor cortex excitability. Brain. 2002 Oct;125(Pt 10):2238-47. doi: 10.1093/brain/awf238.
PubMed 12244081Hamilton RH, Chrysikou EG, Coslett B. Mechanisms of aphasia recovery after stroke and the role of noninvasive brain stimulation. Brain Lang. 2011 Jul;118(1-2):40-50. doi: 10.1016/j.bandl.2011.02.005. Epub 2011 Apr 2.
PubMed 21459427Darkow R, Martin A, Wurtz A, Floel A, Meinzer M. Transcranial direct current stimulation effects on neural processing in post-stroke aphasia. Hum Brain Mapp. 2017 Mar;38(3):1518-1531. doi: 10.1002/hbm.23469. Epub 2016 Nov 11.
PubMed 27859982
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS in Language Recovery and Reorganization in Chronic Aphasia
- ClinicalTrials.gov ID
- NCT04166513
- Acronym / sponsor ID
- 33162
- Keywords
- tDCS, treatment, brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.
Detailed description
Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).
This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.
Study design:
Patients will be randomly assigned to one of 2 speech therapy groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from targeted to active control stimulation (or vice versa).
| Arm | Type | Receives |
|---|---|---|
| Targeted tDCS with Phonologic-Focused Speech Therapy | Experimental | Device: Targeted Transcranial Direct Current Stimulation, Behavioral: Phonologic-Focused Speech TherapyParticipants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before. |
| Active Control tDCS with Phonologic-Focused Speech Therapy | Active comparator | Device: Active Control Transcranial Direct Current Stimulation, Behavioral: Phonologic-Focused Speech TherapyParticipants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions. |
| Targeted tDCS with Semantic-Focused Speech Therapy | Experimental | Device: Targeted Transcranial Direct Current Stimulation, Behavioral: Semantic-Focused Speech TherapyParticipants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions. |
| Active Control tDCS with Semantic-Focused Speech Therapy | Active comparator | Device: Active Control Transcranial Direct Current Stimulation, Behavioral: Semantic-Focused Speech TherapyParticipants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor).
- Patients must be adults and have English-language fluency.
- Patients must be eligible to undergo MRI.
Key exclusion criteria (4 listed)
- Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)
- Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
- No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
- Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, and inability to see or hear stimulus materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Transcranial Direct Current StimulationAlso: HD-tDCS, tDCSHigh-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region. | Device | Targeted tDCS with Phonologic-Focused Speech Therapy, Targeted tDCS with Semantic-Focused Speech Therapy |
| Active Control Transcranial Direct Current StimulationAlso: Active Control tDCS, Active Control HD-tDCSHigh-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region. | Device | Active Control tDCS with Phonologic-Focused Speech Therapy, Active Control tDCS with Semantic-Focused Speech Therapy |
| Phonologic-Focused Speech TherapyAlso: Phonologic Component AnalysisParticipants are asked to generate or choose from a list phonologic information about a target picture. | Behavioural | Active Control tDCS with Phonologic-Focused Speech Therapy, Targeted tDCS with Phonologic-Focused Speech Therapy |
| Semantic-Focused Speech TherapyAlso: Semantic Feature AnalysisParticipants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. | Behavioural | Active Control tDCS with Semantic-Focused Speech Therapy, Targeted tDCS with Semantic-Focused Speech Therapy |
Primary outcome
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0)
Time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post
Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A.
3 secondary outcomes
fMRI- Baseline
Time frame: Baseline
fMRI After Cycle A
Time frame: 10-weeks post Cycle A
fMRI Post Cycle B
Time frame: 10 weeks post cycle B
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17102697Jordan LC, Hillis AE. Disorders of speech and language: aphasia, apraxia and dysarthria. Curr Opin Neurol. 2006 Dec;19(6):580-5. doi: 10.1097/WCO.0b013e3280109260.
- Background: PubMed 11687079Greener J, Enderby P, Whurr R. Pharmacological treatment for aphasia following stroke. Cochrane Database Syst Rev. 2001;2001(4):CD000424. doi: 10.1002/14651858.CD000424.
- Background: PubMed 22592672Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
- Background: PubMed 6202993Lincoln NB, McGuirk E, Mulley GP, Lendrem W, Jones AC, Mitchell JR. Effectiveness of speech therapy for aphasic stroke patients. A randomised controlled trial. Lancet. 1984 Jun 2;1(8388):1197-200. doi: 10.1016/s0140-6736(84)91690-8.
- Background: PubMed 22343643Ellis C, Simpson AN, Bonilha H, Mauldin PD, Simpson KN. The one-year attributable cost of poststroke aphasia. Stroke. 2012 May;43(5):1429-31. doi: 10.1161/STROKEAHA.111.647339. Epub 2012 Feb 16.
- Background: PubMed 21160122Ellis C, Dismuke C, Edwards KK. Longitudinal trends in aphasia in the United States. NeuroRehabilitation. 2010;27(4):327-33. doi: 10.3233/NRE-2010-0616.
- BackgroundBoysen AE, Wertz RT. Clinician Costs in Aphasia Treatment: How Much Is a Word Worth? Clin. Aphasiology 1996;24:207-213.
- Background: PubMed 15947279Meinzer M, Djundja D, Barthel G, Elbert T, Rockstroh B. Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy. Stroke. 2005 Jul;36(7):1462-6. doi: 10.1161/01.STR.0000169941.29831.2a. Epub 2005 Jun 9.
- Background: PubMed 23060684Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.
- Background: PubMed 14677402Paulus W. Transcranial direct current stimulation (tDCS). Suppl Clin Neurophysiol. 2003;56:249-54. doi: 10.1016/s1567-424x(09)70229-6.
- Background: PubMed 10990547Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
- Background: PubMed 11723286Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Pillay, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Transcranial Direct Current Stimulation, Phonologic-Focused Speech Therapy and Semantic-Focused Speech Therapy in people with Stroke and Aphasia, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) (time frame: Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166513, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.