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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining brain stimulation with speech therapy can improve language recovery in individuals who struggle to find words after a stroke. The trial will compare two groups: one receiving active brain stimulation (Transcranial Direct Current Stimulation, or tDCS) and the other receiving a sham treatment, both paired with speech therapy. Individuals who have had a single stroke affecting the left side of the brain, have experienced language difficulties for at least six months, and primarily speak English might be a good fit.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future stroke recovery therapies.

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 prior data suggests that this combination of tDCS and SLT is safe for post-stroke aphasia treatment?

Previous studies have shown that transcranial direct current stimulation (tDCS) is safe for people recovering from a stroke. This treatment uses a gentle electrical current to stimulate the brain and is non-invasive, meaning it doesn't involve surgery or entering the body. Research indicates that combining tDCS with speech-language therapy (SLT) can aid people with post-stroke aphasia, a condition that affects speaking or understanding language due to brain damage.

Most participants in these studies did not experience serious side effects. Some reported minor issues like tingling or itching on the skin where the electrodes were placed, but these were temporary and not harmful. Overall, tDCS is considered well-tolerated, and when used with SLT, it may improve language skills without causing significant adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial direct current stimulation (tDCS) with speech-language therapy (SLT) for post-stroke aphasia because it offers a novel approach to enhancing brain recovery. Unlike traditional speech therapy alone, which is the standard treatment, tDCS provides a gentle electrical current to the scalp, potentially boosting the brain's ability to relearn language skills. The combination of tDCS with SLT could lead to faster and more effective improvements in speech and language abilities. This method is promising because it targets the brain's plasticity, which is its ability to form new connections, offering hope for better outcomes in aphasia recovery.

What evidence suggests that this trial's treatments could be effective for post-stroke aphasia?

Research shows that combining transcranial direct current stimulation (tDCS) with speech-language therapy (SLT) may assist individuals who have difficulty speaking after a stroke. In this trial, participants will receive either active tDCS with SLT or sham tDCS with SLT. Studies suggest that active tDCS combined with SLT can enhance language skills, such as speaking clearly and naming objects. Specifically, early findings indicate that anodal-tDCS, which uses mild electrical stimulation on the brain, can lead to noticeable improvements in naming and communication. This method is considered a promising addition to traditional speech therapy, offering potential benefits for treating speech and language difficulties after a stroke. The gentle electrical stimulation is thought to help the brain reorganize and improve language processing. ^{2 3 6 7 8}

Who Is on the Research Team?

Dana Moser, PhD, CCC-SLP

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000885

Effect of transcranial direct current stimulation combined ... tDCS, in conjunction with SLT, demonstrates potential enhancement in language recovery on post-ischemic stroke aphasia. It may improve speech content, naming ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4964590/

Transcranial Direct Current Stimulation in Post Stroke Aphasia ... tDCS is a promising adjunct to traditional speech-language pathology intervention to address speech-language deficits after stroke and in the neurodegenerative ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04166513

Effects of Transcranial Direct Current Stimulation (tDCS) on ... This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2019.01089/full

Transcranial Direct Current Stimulation to Enhance ... In summary, preliminary data suggest that anodal-tDCS can benefit naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02622945

Effects of Transcranial Direct Current Stimulation in Post- ... This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ... This review analyzes the reported adverse effects in stroke, looking for factors that may induce side-effects.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02461355

Transcranial Direct Current Stimulation for Post-Stroke ... This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during ...

8. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.116.015626

Transcranial Direct Current Stimulation in Poststroke ... We know that the study of tDCS for aphasia rehabilitation is safe and that when combined with speech–language therapy, it can sometimes be ...