Apraxia of SpeechNCT03452202
Using tDCS in Speech-based Stroke Rehabilitation
A study testing Soterix 1x1 line tDCS low-intensity stimulator in people with Apraxia of Speech, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Apraxia of Speech
- What is being tested?
- Soterix 1x1 line tDCS low-intensity stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2019to 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed
- Monolingual (English)
- Single left-hemisphere CVA
- A minimum of six months post-stroke
- Clinical diagnosis of apraxia of speech
- Normal speech perception
- Passing score on the hearing screening.
Who cannot join
- Diagnosis of laryngeal voice disorder
- Dysarthria
- History of speech impairment prior to CVA
- Presence of potential tDCS risk factors: damaged skin at site of stimulation;
- Presence of electrically or magnetically activated implant (including pacemaker);
- metal in any part of their body;
- history of medication-resistant epilepsy in the family;
- past history of seizures or unexplained spells of loss of consciousness.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Buchwald Lab contact
United States2 sites, 2 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Buchwald Lab, buchwald-lab@nyu.edu
Adam
- Recruiting
Burke Rehabilitation Hospital
White Plains, New York, 10605
Josette Hartnett, MPH, johartnett@burke.org
Erika Trovato, DO
About this study
The purpose of this study is to determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.
- Conditions
- Apraxia of Speech
- Being tested
- Soterix 1x1 line tDCS low-intensity stimulator, Sham
- Keywords
- Stroke
- Medical subject headings
- Apraxias, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix 1x1 line tDCS low-intensity stimulatorDevice
Also called Soterix
Introduction of the independent variable (treatment) across three different points in time. Participants will be randomly assigned to have each treatment phase begin after 3, 4, or 6 baseline sessions. This current stimulates the cortex, with anodal stimulation leading to a depolarized state in which neurons are more likely to fire.
ShamDevice
Patients will have two electrodes applied (one anode, one cathode) administering no stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition. Receives: Device: Soterix 1x1 line tDCS low-intensity stimulator; Device: Sham |
| Sham Stimulation | Sham comparator | crossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition. Receives: Device: Soterix 1x1 line tDCS low-intensity stimulator; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accuracy in recordings from tasks from baseline to post treatment
Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start11 Jan 2019
- Primary completion30 Apr 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 Apraxia of SpeechStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Adam Buchwald, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452202
- Sponsor's protocol ID
- 17-01474
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2018
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using tDCS in Speech-based Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT03452202
- Acronym / sponsor ID
- 17-01474
- Conditions
- Apraxia of Speech
- Keywords
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Mar 2018 (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 determine whether the effect of treatment for acquired speech impairment can be enhanced by combining effective behavioral treatment with non-invasive brain stimulation. Transcranial direct current stimulation (tDCS), which delivers low-intensity current to the scalp, and is a safe and well-tolerated approach that poses a non-significant risk to participants. tDCS provides low intensity neural stimulation which has been shown to facilitate motor learning in other domains of stroke rehabilitation such as arm motor learning but the potential to enhance speech motor learning has not been explored. This will be examined with a series of single-case experimental designs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Soterix 1x1 line tDCS low-intensity stimulator, Device: Shamcrossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition. |
| Sham Stimulation | Sham comparator | Device: Soterix 1x1 line tDCS low-intensity stimulator, Device: Shamcrossover design such that each participant receives behavioral treatment twice - once with active stimulation and once with sham stimulation - in order to evaluate differences in improvement based on treatment condition. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Right-handed
- Monolingual (English)
- Single left-hemisphere CVA
- A minimum of six months post-stroke
- Clinical diagnosis of apraxia of speech
Key exclusion criteria (8 listed)
- Diagnosis of laryngeal voice disorder
- Dysarthria
- History of speech impairment prior to CVA
- Presence of potential tDCS risk factors: damaged skin at site of stimulation;
- Presence of electrically or magnetically activated implant (including pacemaker);
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 |
|---|---|---|
| Soterix 1x1 line tDCS low-intensity stimulatorAlso: SoterixIntroduction of the independent variable (treatment) across three different points in time. Participants will be randomly assigned to have each treatment phase begin after 3, 4, or 6 baseline sessions. This current stimulates the cortex, with anodal stimulation leading to a depolarized state in which neurons are more likely to fire. | Device | Active Stimulation, Sham Stimulation |
| ShamPatients will have two electrodes applied (one anode, one cathode) administering no stimulation | Device | Active Stimulation, Sham Stimulation |
Primary outcome
Change in accuracy in recordings from tasks from baseline to post treatment
Time frame: Baseline, 6 Months
Subjects will be given speech production tasks. Recordings of tasks will be scored for accuracy to measure speech motor learning
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 3 Jun 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.
Buchwald Lab contact
Adam Buchwald, MD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix 1x1 line tDCS low-intensity stimulator in people with Apraxia of Speech, run by NYU Langone Health at 2 sites 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 7 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Buchwald Lab (buchwald-lab@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in accuracy in recordings from tasks from baseline to post treatment (time frame: Baseline, 6 Months). 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 3 Jun 2026.