StrokeAphasiatDCSNCT04432883
Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.
A study testing Active Comparator: Experimental: Active cathodal tDCS + language training in people with Stroke and Aphasia, run by University of New Mexico at 1 site in United States.
Trial summary
62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- What is being tested?
- Active Comparator: Experimental: Active cathodal tDCS + language training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 30 Apr 2027
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 25-85
- must be greater than 6 months post-stroke
- must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
- must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
- must be stimulable for naming
Who cannot join
- comorbid neurological disease.
- damage to the anterior right hemisphere.
- significant mood disorder.
- substance/alcohol dependence or abuse within the past year
- presence of any implanted electrical device or contraindications to tDCS or MRI
- recent medical instability (within 4 weeks)
- pregnancy
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
University of New Mexico Center for Brain Recovery and Repair
Albuquerque, New Mexico, 87106
Darbi Gill, 505-925-4043, DMGill@salud.unm.edu
About this study
Official title: Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia
62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.
Read the detailed description
Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS
- Being tested
- Active Comparator: Experimental: Active cathodal tDCS + language training, Sham Comparator: Placebo cathodal tDCS + Speech and language
- Keywords
- Stroke, Aphasia, brain stimulation, communication problems, speech and language therapy
- Medical subject headings
- Stroke, Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Experimental: Active cathodal tDCS + language trainingDevice
Also called Behavioral: Speech and Language Training
Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli.
Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.
Sham Comparator: Placebo cathodal tDCS + Speech and languageBehavioural
Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active cathodal tDCS + Speech-language training | Active comparator | In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays. Receives: Device: Active Comparator: Experimental: Active cathodal tDCS + language training |
| Comparator: Placebo cathodal tDCS + Speech-language training | Sham comparator | In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays.. Receives: Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picture Naming of trained items
Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement
Measured: 3 months
Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, \& Railford, 2008)
Measured: 3 months
Naming Efficiency of trained items
Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
Measured: 3 months
Secondary outcomes (5)
Discourse informativeness - Main Concept Production
Change in discourse informativeness as measured by main concept scores; increased values indicate improvement
Measured: 3 months
Efficiency of discourse informativeness - Main Concept Production
Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency
Measured: 3 months
Picture Naming of untrained items - Boston Naming Test
Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement
Measured: 3 months
Naming Response Time of untrained items - Boston Naming Test
Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement
Measured: 3 months
Naming Efficiency of untrained items - Boston Naming Test
Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start18 Oct 2022
- Primary completion26 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Jessica Richardson, University of New Mexico
- Investigators
- Jessica Richardson, Ph.D., Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432883
- Sponsor's protocol ID
- UNM HRRC #16-091
- Other IDs
- 1P20GM109089-01A1, R01DC018282
- Acronym
- AphasiatDCS
- Status last verified
- May 2026
- First submitted
- 3 Dec 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia
- ClinicalTrials.gov ID
- NCT04432883
- Acronym / sponsor ID
- AphasiatDCS / UNM HRRC #16-091
- Keywords
- Stroke, Aphasia, brain stimulation, communication problems, speech and language therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 Jun 2020 (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.
62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.
Detailed description
Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS
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 |
|---|---|---|
| Experimental: Active cathodal tDCS + Speech-language training | Active comparator | Device: Active Comparator: Experimental: Active cathodal tDCS + language trainingIn this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays. |
| Comparator: Placebo cathodal tDCS + Speech-language training | Sham comparator | Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and languageIn this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays.. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 25-85
- must be greater than 6 months post-stroke
- must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
- must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
- must be stimulable for naming
Key exclusion criteria (7 listed)
- comorbid neurological disease.
- damage to the anterior right hemisphere.
- significant mood disorder.
- substance/alcohol dependence or abuse within the past year
- presence of any implanted electrical device or contraindications to tDCS or MRI
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 |
|---|---|---|
| Active Comparator: Experimental: Active cathodal tDCS + language trainingAlso: Behavioral: Speech and Language TrainingCathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli. Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. | Device | Experimental: Active cathodal tDCS + Speech-language training |
| Sham Comparator: Placebo cathodal tDCS + Speech and languageSpeech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. . | Behavioural | Comparator: Placebo cathodal tDCS + Speech-language training |
Primary outcome
Picture Naming of trained items
Time frame: 3 months
Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement
Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
Time frame: 3 months
Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, \& Railford, 2008)
Naming Efficiency of trained items
Time frame: 3 months
Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
5 secondary outcomes
Discourse informativeness - Main Concept Production
Time frame: 3 months
Efficiency of discourse informativeness - Main Concept Production
Time frame: 3 months
Picture Naming of untrained items - Boston Naming Test
Time frame: 3 months
Naming Response Time of untrained items - Boston Naming Test
Time frame: 3 months
Naming Efficiency of untrained items - Boston Naming Test
Time frame: 3 months
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 22 May 2026.
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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.
Jessica Richardson, Ph.D. principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Experimental: Active cathodal tDCS + language training in people with Stroke and Aphasia, run by University of New Mexico 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 5 inclusion and 7 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 22 May 2026. 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 Jessica Richardson, Ph.D. (505 277-1765, jdrichardson@unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Picture Naming of trained items (time frame: 3 months). The study lists 3 primary outcomes in all. 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 22 May 2026.