StrokeNCT03699930
Impact of Neuromodulation on Language Impairments in Stroke Patients
A study testing tDCS and Speech and language therapy in people with Stroke and Aphasia, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial summary
Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- tDCS and Speech and language therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Between ages 18-85
- At least 12 months post stroke
- Diagnosed with aphasia due to ischemic or hemorrhagic stroke
- English speaking
- Right handed prior to stroke
Who cannot join
- Nonverbal
- Other neurological diseases/disorders
- Not MRI-compatible (e.g. claustrophobia, metal implants in the head)
Trial locations and contacts
1 site in 1 country.
United States1 site
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91769
About this study
Official title: Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study
Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.
Read the detailed description
Approximately one million people in the United States are living with aphasia, an acquired neurological disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients. Recent evidence suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost neuromodulation technique, applied in conjunction with speech therapy may be more effective in promoting language recovery than behavioral intervention alone.
A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo) group and will receive 20 minutes of concurrent speech and language therapy by a trained speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired within one week before and after intervention. Genetic samples will be collected once. Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham intervention to assess long-term benefits.
- Being tested
- tDCS, Speech and language therapy
- Keywords
- transcranial direct current stimulation, stroke, aphasia, speech therapy, neurorehabilitation, neuromodulation, language function, neuroplasticity, neuroimaging, EEG, MRI, genetics, language disorders
- Medical subject headings
- Stroke, Aphasia, Communication Disorders, Language, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Anodal or sham tDCS will be applied to the scalp.
Speech and language therapyBehavioural
A trained speech pathologist will administer the speech and language therapy.
| Study group | Role | What they receive |
|---|---|---|
| tDCS + speech therapy | Active comparator | Participants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days. Receives: Device: tDCS; Behavioral: Speech and language therapy |
| sham + speech therapy | Sham comparator | Participants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days. Receives: Device: tDCS; Behavioral: Speech and language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Aphasia Battery-Revised scores
WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.
Measured: At baseline and at week 3
Secondary outcomes (6)
Change in Magnetic Resonance Imaging (MRI)
MRI scans will be acquired on a Siemens Magnetom Verio 3T Scanner at Casa Colina Imaging Center to assess structural changes.
Measured: At baseline and at week 3
Change in resting state Electroencephalograph (EEG) signals
Using a B-Alert wireless EEG system, we will perform eyes-open resting-state EEG recordings to assess power spectral density changes.
Measured: At baseline and at week 3
Change in Test of Nonverbal Intelligence (TONI-4)
TONI-4 is a language-free intelligence test for evaluating those with limited language ability.
Measured: At baseline and at week 3
Change in Communication Outcomes after Stroke (COAST)
The COAST is used to assess self-perceived communication effectiveness for people with aphasia.
Measured: At baseline, at week 3, and at week 17
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS is used to assess physical, mental, and social health.
Measured: At baseline, at week 3, and at week 17
Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
The SAQOL-39 is used to assess health-related quality of life in people with long-term aphasia.
Measured: At baseline, at week 3, and at week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Jan 2018
- Primary completion1 Sep 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- double-blind quasi-randomized controlled design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Zheng, Casa Colina Hospital and Centers for Healthcare
- Investigators
- Amy Zheng, PhD, Principal investigator, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699930
- Sponsor's protocol ID
- TDCS
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2018
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Zheng ZS, Wang J, Lee S, Wang KX, Zhang B, Howard M, Rosario E, Schnakers C. Cerebellar transcranial direct current stimulation improves quality of life in individuals with chronic poststroke aphasia. Sci Rep. 2025 Feb 26;15(1):6898. doi: 10.1038/s41598-025-90927-y.
PubMed 40011597
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuromodulation on Language Impairments in Stroke Patients: a Multimodal Double-blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03699930
- Acronym / sponsor ID
- TDCS
- Keywords
- transcranial direct current stimulation, stroke, aphasia, speech therapy, neurorehabilitation, neuromodulation, language function, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 9 Oct 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.
Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a top priority in stroke rehabilitation. Conventional speech and language therapy may have limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics), this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine neural changes associated with recovery, 3) identify factors influencing response to treatment.
Detailed description
Approximately one million people in the United States are living with aphasia, an acquired neurological disorder affecting the ability to use and/or understand language. This communication impairment affects up to 40% of stroke patients. Stroke victims usually prioritize speaking, writing, and walking as the three most important rehabilitation goals, two of these goals therefore involving communication. Conventional speech therapy strategies have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of those affected will remain in this state despite intensive speech therapy. Effective novel treatment is therefore warranted to improve recovery in these patients. Recent evidence suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost neuromodulation technique, applied in conjunction with speech therapy may be more effective in promoting language recovery than behavioral intervention alone.
A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo) group and will receive 20 minutes of concurrent speech and language therapy by a trained speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired within one week before and after intervention. Genetic samples will be collected once. Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham intervention to assess long-term benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind quasi-randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| tDCS + speech therapy | Active comparator | Device: tDCS, Behavioral: Speech and language therapyParticipants will receive 20 minutes of anodal tDCS paired with speech and language therapy over five consecutive days. |
| sham + speech therapy | Sham comparator | Device: tDCS, Behavioral: Speech and language therapyParticipants will receive 20 minutes of sham tDCS paired with speech and language therapy over five consecutive days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between ages 18-85
- At least 12 months post stroke
- Diagnosed with aphasia due to ischemic or hemorrhagic stroke
- English speaking
- Right handed prior to stroke
Key exclusion criteria (3 listed)
- Nonverbal
- Other neurological diseases/disorders
- Not MRI-compatible (e.g. claustrophobia, metal implants in the head)
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 |
|---|---|---|
| tDCSAnodal or sham tDCS will be applied to the scalp. | Device | sham + speech therapy, tDCS + speech therapy |
| Speech and language therapyA trained speech pathologist will administer the speech and language therapy. | Behavioural | sham + speech therapy, tDCS + speech therapy |
Primary outcome
Change in Western Aphasia Battery-Revised scores
Time frame: At baseline and at week 3
WAB-R is an instrument for assessing the language function of adults with suspected neurological disorders as a result of a stroke.
6 secondary outcomes
Change in Magnetic Resonance Imaging (MRI)
Time frame: At baseline and at week 3
Change in resting state Electroencephalograph (EEG) signals
Time frame: At baseline and at week 3
Change in Test of Nonverbal Intelligence (TONI-4)
Time frame: At baseline and at week 3
Change in Communication Outcomes after Stroke (COAST)
Time frame: At baseline, at week 3, and at week 17
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: At baseline, at week 3, and at week 17
Change in Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Time frame: At baseline, at week 3, and at week 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Derived from this study: PubMed 40011597Zheng ZS, Wang J, Lee S, Wang KX, Zhang B, Howard M, Rosario E, Schnakers C. Cerebellar transcranial direct current stimulation improves quality of life in individuals with chronic poststroke aphasia. Sci Rep. 2025 Feb 26;15(1):6898. doi: 10.1038/s41598-025-90927-y.
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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.
Amy Zheng, PhD principal investigator
Casa Colina Hospital and Centers for Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Speech and language therapy in people with Stroke and Aphasia, run by Casa Colina Hospital and Centers for Healthcare 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 3 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 7 Jul 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Western Aphasia Battery-Revised scores (time frame: At baseline and at week 3). 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 NCT03699930, which also lists 1 linked publication.
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 Jul 2023.