tDCS + SLT for Post-Stroke Aphasia

Overseen By Dana Moser, PhD, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Neurological disease, Major mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment tDCS + SLT for Post-Stroke Aphasia?

Research shows that combining transcranial direct current stimulation (tDCS) with speech language therapy (SLT) can help improve language skills in people who have trouble speaking after a stroke. Studies suggest that tDCS can enhance the effects of SLT, making it a promising approach for treating aphasia (language impairment) in stroke patients. ^{1 2 3 4 5}

Is tDCS combined with SLT safe for humans?

Research indicates that transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) is generally safe for humans, with no serious adverse events reported in studies involving stroke survivors with aphasia. ^{3 5 6 7 8}

How is the tDCS + SLT treatment for post-stroke aphasia different from other treatments?

The tDCS + SLT treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with speech and language therapy (SLT) to enhance language recovery in stroke survivors with aphasia. Unlike standard treatments, this approach targets the brain's language areas directly and has shown potential for greater language improvement when used over an extended period. ^{1 2 3 6 9}

What is the purpose of this trial?

The purpose this study is to test the utility of pairing external neuromodulation with behavioral language treatment to boost therapy outcomes and to investigate the mechanisms associated with recovery. Because all PWA have word retrieval deficits, this project will test if greater language gains can be achieved by supplementing anomia intervention with excitatory brain stimulation to the left hemisphere and will evaluate associated functional brain changes to aid the optimization of neural reorganization to facilitate language processing.

Research Team

Dana Moser, PhD, CCC-SLP

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for individuals aged 18-80 who have had a stroke on the left side of their brain at least 6 months ago, resulting in aphasia. They must speak English natively and have good hearing and vision. People with severe comprehension deficits, other neurological diseases or major mental illnesses, conditions not suitable for MRI or tDCS (like seizures), or pregnant women cannot participate.

Inclusion Criteria

I had a stroke that affected the left side of my brain.

I can see and hear well enough to do tasks.

It has been over 6 months since my stroke.

Exclusion Criteria

If you are a woman, you are pregnant.

You have a history of serious mental health conditions like schizophrenia, drug addiction, or bipolar disorder.

I have a history of a brain-related condition or injury.

Timeline

Baseline Assessment

Participants complete the Neuropsychological Testing Battery and the first round of outcome measures as pre-testing before starting SLT

1 week

1 visit (in-person)

Intervention Phase 1

Participants receive 2 weeks of Speech-Language Therapy (SLT) with either active tDCS or sham tDCS

2 weeks

Multiple visits (in-person)

Outcome Testing 1

Participants complete post-testing for the 1st SLT phase and pre-testing for the 2nd SLT phase

1 week

1 visit (in-person)

Intervention Phase 2

Participants receive another 2 weeks of SLT with the other tDCS condition

2 weeks

Multiple visits (in-person)

Outcome Testing 2

Participants complete post-testing for the 2nd SLT phase

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

1 visit (in-person)

Treatment Details

Interventions

• Active Transcranial Direct Current Stimulation with SLT
• Sham Transcranial Direct Current Stimulation with SLT

Trial Overview The study is examining if using Transcranial Direct Current Stimulation (tDCS) alongside Speech-Language Therapy (SLT) can improve language skills better than SLT alone in people with aphasia after a stroke. It also looks at how the brain changes functionally during this process.

Participant Groups

Group I: Active tDCS (with Speech-Language Treatment) Active Control 1 Intervention

tDCS Stimulation Dose: 1.5 mA for 20-mins

Group II: Sham tDCS (with Speech-Language Treatment) Placebo Group 1 Intervention

No tDCS stimulation

Active Transcranial Direct Current Stimulation with SLT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as tDCS for:

• Post-stroke aphasia rehabilitation

Approved in United States as tDCS for:

• Post-stroke aphasia rehabilitation

Approved in Canada as tDCS for:

• Post-stroke aphasia rehabilitation

Approved in Japan as tDCS for:

• Post-stroke aphasia rehabilitation

Approved in China as tDCS for:

• Post-stroke aphasia rehabilitation

Approved in Switzerland as tDCS for:

• Post-stroke aphasia rehabilitation

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

In a study of 37 stroke patients, speech therapy combined with transcranial direct current stimulation (tDCS) significantly improved language function, with an average increase in aphasia quotient (AQ%) of 14.94% after treatment.

Patients with less severe, fluent types of aphasia who started treatment within 30 days of their stroke showed the best responses, and those with hemorrhagic strokes had a higher likelihood of improvement compared to those with infarctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Factors Associated with Good Responses to Speech Therapy Combined with Transcranial Direct Current Stimulation in Post-stroke Aphasic Patients. Jung, IY., Lim, JY., Kang, EK., et al.[2021]

In a study involving 11 chronic stroke patients with aphasia, dual transcranial direct current stimulation (tDCS) showed a significant improvement in naming response times compared to baseline, suggesting enhanced efficacy over single tDCS.

Both single and dual tDCS improved the number of correct responses in naming tasks, but dual tDCS, which targeted both the left and right inferior frontal gyri, may offer greater benefits for language recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dual transcranial direct current stimulation for aphasia in chronic stroke patients. Lee, SY., Cheon, HJ., Yoon, KJ., et al.[2021]

In a study of 58 right-handed English speakers with subacute aphasia, transcranial direct-current stimulation (tDCS) did not significantly enhance picture naming accuracy compared to sham treatment, indicating limited efficacy for this specific outcome.

However, tDCS was associated with greater improvements in discourse skills, which are important for communication, and no adverse events were reported, suggesting it is a safe adjunct to language therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. Stockbridge, MD., Elm, J., Breining, BL., et al.[2023]

Transcranial direct current stimulation (tDCS) applied to the left inferior frontal gyrus significantly improved language abilities in patients with nonfluent poststroke aphasia when combined with speech language therapy, as shown by a higher Aphasia Quotient in the A-tDCS group compared to the sham group (72.99 vs. 46.18).

The study involved 18 patients over four weeks, with results indicating that tDCS enhances the effectiveness of speech language therapy, particularly in areas other than comprehension, suggesting a beneficial mechanism of action for language recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Anodic Transcranial Direct Current Stimulation Combined With Speech Language Therapy on Nonfluent Poststroke Aphasia. Zhao, Q., Wang, J., Li, Z., et al.[2022]

Transcranial direct-current stimulation (tDCS) significantly improved articulatory accuracy in patients with aphasia after stroke, indicating its potential effectiveness in enhancing speech production.

While tDCS showed qualitative improvements in naming and syllable repetition tasks, these results were not statistically significant, suggesting that further research is needed to fully understand its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial. Vila-Nova, C., Lucena, PH., Lucena, R., et al.[2021]

Transcranial direct current stimulation (tDCS) combined with speech and language treatment (SLT) is safe for stroke survivors with aphasia, showing no serious adverse events during a six-week treatment involving 30 sessions.

Participants receiving active tDCS exhibited greater improvements in functional language compared to those receiving sham treatment, suggesting that tDCS may enhance the effectiveness of SLT, although the superiority of one stimulation polarity over another remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial. Cherney, LR., Babbitt, EM., Wang, X., et al.[2021]

In a study involving 10 individuals undergoing standard aphasia therapy, 70% expressed interest in and were eligible for transcranial direct current stimulation (tDCS), which was administered during therapy sessions.

Data from four participants showed a large effect size (Cohen's d = 1.32) favoring active tDCS over sham stimulation, suggesting that tDCS may enhance communication outcomes in aphasia therapy, although one participant with severe deficits did not benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. Duncan, ES., Nakkawita, SG.[2022]

A systematic review of 25 studies involving 471 participants found that Transcranial Direct Current Stimulation (tDCS) did not improve overall functional communication in stroke patients, indicating limited efficacy for this primary outcome.

However, anodal tDCS, especially when applied over the left inferior frontal gyrus, showed a significant improvement in noun naming performance, suggesting it may be a promising targeted treatment for specific language deficits after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia after stroke: a systematic review with network meta-analysis of randomized controlled trials. Elsner, B., Kugler, J., Mehrholz, J.[2020]

In a study involving eight chronic non-fluent post-stroke aphasic patients, cathodal transcranial direct current stimulation (tDCS) significantly improved picture naming accuracy by an average of 33.6%.

Anodal and sham tDCS did not produce any noticeable changes in performance, suggesting that cathodal tDCS may be a promising technique for enhancing language recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved naming after transcranial direct current stimulation in aphasia. Monti, A., Cogiamanian, F., Marceglia, S., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

The Factors Associated with Good Responses to Speech Therapy Combined with Transcranial Direct Current Stimulation in Post-stroke Aphasic Patients. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of dual transcranial direct current stimulation for aphasia in chronic stroke patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Anodic Transcranial Direct Current Stimulation Combined With Speech Language Therapy on Nonfluent Poststroke Aphasia. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of Anodal tDCS on Articulatory Accuracy, Word Production, and Syllable Repetition in Subjects with Aphasia: A Crossover, Double-Blinded, Sham-Controlled Trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Clinical Feasibility of Combining Transcranial Direct Current Stimulation with Standard Aphasia Therapy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia after stroke: a systematic review with network meta-analysis of randomized controlled trials. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Improved naming after transcranial direct current stimulation in aphasia. [2022]