AphasiaNCT04142866
Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
A study testing Anodal transcranial direct current stimulation and Speech-Language Therapy (SLT) in people with Aphasia and Stroke, run by City University of New York at 1 site in United States.
Trial summary
The purpose of this study is to assess changes in language abilities of participants with chronic, post-stroke aphasia following an 8-week therapy period combined with brain stimulation. The investigators use a stimulation method called transcranial direct current stimulation (tDCS). Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Anodal transcranial direct current stimulation and Speech-Language Therapy (SLT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right handed (pre-stroke for participants with aphasia)
- High school education or equivalent
- Native English fluency without early 2nd language exposure (before age 10)
- Ability to perform the required discourse and MRI tasks (determined via in-person screening)
- Additional INCLUSION Criteria for participants with APHASIA:
- Single-event left hemisphere stroke > 6 months prior to enrollment
Show all 9Show fewer
- Aphasia diagnosis per Western Aphasia Battery-Revised
- Not receiving any other speech therapy for the entire study period (20 weeks)
- Ability to perform the required therapy tasks (determined via in-person screening)
Who cannot join
- Failed vision or hearing screening
- MRI contraindications (including pacemaker)
- Pregnancy
- History of seizure or change in seizure medication in past 12 months
- History of speech/language, psychiatric, or neurological disorder, or current serious medical condition (except chronic stroke comorbidities for participants with aphasia)
- Additional EXCLUSION criteria for participants with APHASIA are:
- Unmodifiable hair style precluding scalp contact by electrodes
- Sensitive scalp by self-report
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City University of New York
New York, New York, 10016
E. Susan Duncan, PhD, CCC-SLP, 212-817-8804, esduncan@gc.cuny.edu
E. Susan Duncan, PhD, CCC-SLP
About this study
The purpose of this study is to assess changes in language abilities of participants with chronic, post-stroke aphasia following an 8-week therapy period combined with brain stimulation. The investigators use a stimulation method called transcranial direct current stimulation (tDCS). The investigators cover two electrodes in damp sponges, place them on the scalp, and pass a weak electrical current between them. Some of this current passes through the brain and can change brain activity. One electrode is placed over language areas a bit above and in front of the left ear. The other is placed on the forehead above the right eye. Stimulation is provided twice a week for 8 weeks during aphasia therapy. The investigators believe that this stimulation may increase the effectiveness of therapy.
Read the detailed description
General Study Design: Following screening, participants complete four behavioral assessments and four brain scans (magnetic resonance imaging; MRI). Two behavioral assessments and two brain scans occur in the month before tDCS and therapy (about 3 weeks apart). One behavioral assessment and one brain scan occur in the week following therapy. The last behavioral assessment and brain scan occur approximately 8 weeks after therapy. Participants cannot receive any other speech therapy while enrolled in this study (about 20 weeks or 5 months).
Screening: Participants are screened twice, once by phone or email and once in-person at the City University of New York (CUNY). Screenings address eligibility, including adequate hearing and vision, ability to perform all required tasks, and safety for tDCS and MRI (brain scans). The investigators also collect medical and demographic information to ensure study eligibility.
Behavioral Assessment: Language samples are elicited on 11 discourse tasks, including picture descriptions, general questions, and telling a story. The Western Aphasia Battery-Revised and Boston Naming Test are also administered. These procedures are video recorded for later review and transcription. Participants also complete a pre-tDCS safety screening questionnaire. Our primary outcome measure is performance on the discourse tasks, for which the investigators measure the number of correct information units (CIUs) produced. Words are counted as correct information units if they are novel, intelligible, informative, and appropriate to the task.
Brain Scans: Brain scans (MRI) are collected at the CUNY Advanced Science Research Center (85 St. Nicholas Terrace, New York, NY 10031). Each brain scan lasts about 45 minutes. There is one task of approximately 7 minutes that will require decision-making and responses by pressing a button with the left hand. For the rest of the time, the participant simply lies still while the MRI acquires images of the brain.
Therapy: Therapy is provided for two 1-hour sessions per week for 8 weeks at the CUNY Graduate Center (365 Fifth Avenue, New York, NY 10016). This is a typical behavioral aphasia therapy intended to improve language skills. The investigators use a therapy called Verb Network Strengthening Treatment (VNeST) that has demonstrated effectiveness in a small number of research studies. tDCS (see below) is administered for the first 20 minutes of each aphasia therapy session.
tDCS: Participants undergo placement of two tDCS electrodes encased in damp sponges (saline solution). For all subjects, one electrode (anodal) is placed at the following location (EEG 10-20 system): (i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)
The other electrode (cathodal) is placed at the second site:
(ii) over right frontal pole (Fp2) Stimulation is delivered by a Soterix tDCS device for 20 minutes at an intensity of 2 milliamps (mA).
Participants are randomly assigned on an individual basis to receive either active or sham tDCS. In the sham condition, stimulation is ramped up over the first 30 seconds (as in the active condition), but then discontinued. This gives the physical perception of stimulation without the modulatory effects.
The investigators will recruit 30 total participants with aphasia for this study. There will be two parallel groups; fifteen participants will receive active tDCS and fifteen will receive sham tDCS. The investigators chose these numbers based on a preliminary trial with four participants who received aphasia treatment on the same schedule and tDCS using the same parameters. These four participants both had active and sham stimulation (crossover design) and performed much better on our primary outcome measure when they had active stimulation (i.e., produced more CIUs after active stimulation compared to before). The investigators performed a power analysis using the effect size for those four participants and determined that 30 participants will be adequate to show significant effects with two different groups.
- Being tested
- Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation, Speech-Language Therapy (SLT)
- Keywords
- aphasia, stroke, tDCS, language, stimulation, brain, speech therapy
- Medical subject headings
- Aphasia, Stroke, Language, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationDevice
Also called A-tDCS
2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the active tDCS condition, stimulation continues for the first 20 minutes of the 60-minute treatment session, and then ramps back down to 0 milliamps (mA).
Sham transcranial direct current stimulationDevice
Also called Sham
2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the sham tDCS condition, the current is only on for 30 seconds before it is ramped back down to 0 milliamps (mA), although the electrodes are still worn for 20 minutes.
Speech-Language Therapy (SLT)Behavioural
Also called SLT
Therapy provided is Verb Network Strengthening Treatment (VNeST). Therapy sessions last for 60 minutes and are provided twice weekly for 8 weeks. Active or sham tDCS is delivered during the first 20 minutes of therapy. The therapist is blinded to stimulation condition (active or sham).
| Study group | Role | What they receive |
|---|---|---|
| A-tDCS & speech-language therapy | Experimental | Anodal transcranial direct current stimulation (2 milliamps [mA]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2 milliamps (mA) for a maximum of 20 minutes. Receives: Device: Anodal transcranial direct current stimulation; Behavioral: Speech-Language Therapy (SLT) |
| Sham-tDCS & speech-language therapy | Sham comparator | Sham transcranial direct current stimulation (2 milliamps [mA]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 milliamps (mA). Receives: Device: Sham transcranial direct current stimulation; Behavioral: Speech-Language Therapy (SLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of Correct Information Units (CIUs) on Discourse Tasks
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, informative, and appropriate in context (Nicholas \& Brookshire, 1993).
Measured: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Secondary outcomes (2)
Western Aphasia Battery-Revised
Aphasia quotient calculated from this comprehensive aphasia battery. Range is 0 to 100, where 100 represents a perfect score and scores above 93.8 indicate that aphasia is not present.
Measured: Collected once at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Boston Naming Test
Number correct of the 60 items on this naming test
Measured: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start3 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Susan Duncan, City University of New York
- Investigators
- E. Susan Duncan, PhD, CCC-SLP, Principal investigator, City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142866
- Sponsor's protocol ID
- 2023-0605-GC
- Status last verified
- Jan 2025
- First submitted
- 25 Oct 2019
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators are committed to open, reproducible science to ensure rigor and complete transparency of our methods and data quality. Therefore, after the publication of findings, the investigators will share data with the scientific research community. Anonymized functional magnetic resonance imaging data and associated behavioral data will be uploaded to the OpenNeuro database: https://openneuro.org/
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
- ClinicalTrials.gov ID
- NCT04142866
- Acronym / sponsor ID
- 2023-0605-GC
- Keywords
- aphasia, stroke, tDCS, language, stimulation, brain, speech therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- City University of New YorkUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess changes in language abilities of participants with chronic, post-stroke aphasia following an 8-week therapy period combined with brain stimulation. The investigators use a stimulation method called transcranial direct current stimulation (tDCS). The investigators cover two electrodes in damp sponges, place them on the scalp, and pass a weak electrical current between them. Some of this current passes through the brain and can change brain activity. One electrode is placed over language areas a bit above and in front of the left ear. The other is placed on the forehead above the right eye. Stimulation is provided twice a week for 8 weeks during aphasia therapy. The investigators believe that this stimulation may increase the effectiveness of therapy.
Detailed description
General Study Design: Following screening, participants complete four behavioral assessments and four brain scans (magnetic resonance imaging; MRI). Two behavioral assessments and two brain scans occur in the month before tDCS and therapy (about 3 weeks apart). One behavioral assessment and one brain scan occur in the week following therapy. The last behavioral assessment and brain scan occur approximately 8 weeks after therapy. Participants cannot receive any other speech therapy while enrolled in this study (about 20 weeks or 5 months).
Screening: Participants are screened twice, once by phone or email and once in-person at the City University of New York (CUNY). Screenings address eligibility, including adequate hearing and vision, ability to perform all required tasks, and safety for tDCS and MRI (brain scans). The investigators also collect medical and demographic information to ensure study eligibility.
Behavioral Assessment: Language samples are elicited on 11 discourse tasks, including picture descriptions, general questions, and telling a story. The Western Aphasia Battery-Revised and Boston Naming Test are also administered. These procedures are video recorded for later review and transcription. Participants also complete a pre-tDCS safety screening questionnaire. Our primary outcome measure is performance on the discourse tasks, for which the investigators measure the number of correct information units (CIUs) produced. Words are counted as correct information units if they are novel, intelligible, informative, and appropriate to the task.
Brain Scans: Brain scans (MRI) are collected at the CUNY Advanced Science Research Center (85 St. Nicholas Terrace, New York, NY 10031). Each brain scan lasts about 45 minutes. There is one task of approximately 7 minutes that will require decision-making and responses by pressing a button with the left hand. For the rest of the time, the participant simply lies still while the MRI acquires images of the brain.
Therapy: Therapy is provided for two 1-hour sessions per week for 8 weeks at the CUNY Graduate Center (365 Fifth Avenue, New York, NY 10016). This is a typical behavioral aphasia therapy intended to improve language skills. The investigators use a therapy called Verb Network Strengthening Treatment (VNeST) that has demonstrated effectiveness in a small number of research studies. tDCS (see below) is administered for the first 20 minutes of each aphasia therapy session.
tDCS: Participants undergo placement of two tDCS electrodes encased in damp sponges (saline solution). For all subjects, one electrode (anodal) is placed at the following location (EEG 10-20 system): (i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)
The other electrode (cathodal) is placed at the second site:
(ii) over right frontal pole (Fp2) Stimulation is delivered by a Soterix tDCS device for 20 minutes at an intensity of 2 milliamps (mA).
Participants are randomly assigned on an individual basis to receive either active or sham tDCS. In the sham condition, stimulation is ramped up over the first 30 seconds (as in the active condition), but then discontinued. This gives the physical perception of stimulation without the modulatory effects.
The investigators will recruit 30 total participants with aphasia for this study. There will be two parallel groups; fifteen participants will receive active tDCS and fifteen will receive sham tDCS. The investigators chose these numbers based on a preliminary trial with four participants who received aphasia treatment on the same schedule and tDCS using the same parameters. These four participants both had active and sham stimulation (crossover design) and performed much better on our primary outcome measure when they had active stimulation (i.e., produced more CIUs after active stimulation compared to before). The investigators performed a power analysis using the effect size for those four participants and determined that 30 participants will be adequate to show significant effects with two different groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-tDCS & speech-language therapy | Experimental | Device: Anodal transcranial direct current stimulation, Behavioral: Speech-Language Therapy (SLT)Anodal transcranial direct current stimulation (2 milliamps [mA]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2 milliamps (mA) for a maximum of 20 minutes. |
| Sham-tDCS & speech-language therapy | Sham comparator | Device: Sham transcranial direct current stimulation, Behavioral: Speech-Language Therapy (SLT)Sham transcranial direct current stimulation (2 milliamps [mA]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 milliamps (mA). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Right handed (pre-stroke for participants with aphasia)
- High school education or equivalent
- Native English fluency without early 2nd language exposure (before age 10)
- Ability to perform the required discourse and MRI tasks (determined via in-person screening)
- Single-event left hemisphere stroke > 6 months prior to enrollment
Key exclusion criteria (8 listed)
- Failed vision or hearing screening
- MRI contraindications (including pacemaker)
- Pregnancy
- History of seizure or change in seizure medication in past 12 months
- History of speech/language, psychiatric, or neurological disorder, or current serious medical condition (except chronic stroke comorbidities for participants with aphasia)
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 |
|---|---|---|
| Anodal transcranial direct current stimulationAlso: A-tDCS2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the active tDCS condition, stimulation continues for the first 20 minutes of the 60-minute treatment session, and then ramps back down to 0 milliamps (mA). | Device | A-tDCS & speech-language therapy |
| Sham transcranial direct current stimulationAlso: Sham2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the sham tDCS condition, the current is only on for 30 seconds before it is ramped back down to 0 milliamps (mA), although the electrodes are still worn for 20 minutes. | Device | Sham-tDCS & speech-language therapy |
| Speech-Language Therapy (SLT)Also: SLTTherapy provided is Verb Network Strengthening Treatment (VNeST). Therapy sessions last for 60 minutes and are provided twice weekly for 8 weeks. Active or sham tDCS is delivered during the first 20 minutes of therapy. The therapist is blinded to stimulation condition (active or sham). | Behavioural | A-tDCS & speech-language therapy, Sham-tDCS & speech-language therapy |
Primary outcome
Production of Correct Information Units (CIUs) on Discourse Tasks
Time frame: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, informative, and appropriate in context (Nicholas \& Brookshire, 1993).
2 secondary outcomes
Western Aphasia Battery-Revised
Time frame: Collected once at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Boston Naming Test
Time frame: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Yes. The investigators are committed to open, reproducible science to ensure rigor and complete transparency of our methods and data quality. Therefore, after the publication of findings, the investigators will share data with the scientific research community. Anonymized functional magnetic resonance imaging data and associated behavioral data will be uploaded to the OpenNeuro database: https://openneuro.org/
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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.
E. Susan Duncan, PhD, CCC-SLP principal investigator
City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation and Speech-Language Therapy (SLT) in people with Aphasia and Stroke, run by City University of New York 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 7 Jan 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E. Susan Duncan, PhD, CCC-SLP (212 817 8804, esduncan@gc.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of Correct Information Units (CIUs) on Discourse Tasks (time frame: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.