tDCS + Speech Therapy for Aphasia

Overseen By Sidney Schoenrock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Alzheimer's, Epilepsy, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 22

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mild electrical stimulation, combined with speech therapy, can improve language recovery for individuals with aphasia after a stroke. The study includes different groups testing combinations of targeted and active control electrical stimulation (Transcranial Direct Current Stimulation, or tDCS) with two types of speech therapy: phonologic-focused and semantic-focused. Individuals who have experienced a stroke or similar brain injury and have language difficulties might be suitable participants, especially if they are comfortable with MRI scans. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance language recovery methods.

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 method is safe for people with post-stroke aphasia?

Research has shown that transcranial Direct Current Stimulation (tDCS) is generally safe. tDCS uses mild electrical currents to stimulate the brain and is both noninvasive and painless. It has been used without causing serious side effects or brain injury. Some people might feel mild itching or burning on their skin, but these effects are not serious.

When combined with speech therapy, as in this study, tDCS may help stroke patients recover language skills. This suggests that the treatment is well-tolerated, even when used in different ways.

Overall, both targeted tDCS and active control tDCS treatments appear safe. They have been tested in various settings, showing they can be used without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining transcranial direct current stimulation (tDCS) with speech therapy for aphasia because it offers a novel approach compared to traditional speech therapy alone. While standard treatments focus solely on language exercises, tDCS uses a mild electrical current to stimulate specific brain areas, potentially enhancing the brain's ability to recover language functions. This method could accelerate and improve the effectiveness of speech therapy by directly targeting underlying neural pathways. By exploring both phonologic-focused and semantic-focused speech therapy, this approach could provide tailored interventions that address different aspects of language recovery.

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

Research shows that transcranial direct current stimulation (tDCS) can help people with aphasia, a language problem after a stroke, improve their language skills. Studies suggest that combining tDCS with speech therapy enhances the effectiveness of the therapy. In this trial, participants will receive either targeted tDCS or active control tDCS, each paired with phonologic-focused or semantic-focused speech therapy. Both specific and general types of tDCS have shown promise in helping patients regain language abilities. Specifically, anodal tDCS, which uses a gentle electrical current, has been tested and found to enhance the benefits of language therapy. This treatment stimulates brain areas involved in speech and language. Early research indicates it might be a useful tool for those struggling with language after a stroke. ^{2 3 4 6 7}

Who Is on the Research Team?

Sara Pillay, Ph.D

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults who have language difficulties due to brain damage like a stroke. They must speak English fluently and be able to undergo an MRI scan. People with advanced neurodegenerative diseases, severe psychiatric conditions, uncorrectable hearing or vision issues, developmental disabilities, or contraindications to MRI are not eligible.

Inclusion Criteria

You are able to have an MRI scan.

I am an adult who speaks and understands English fluently.

I have language difficulties due to a stroke or brain tumor.

Exclusion Criteria

You have a serious mental illness like schizophrenia, bipolar disorder, or severe depression.

I have an advanced stage of a brain condition like Alzheimer's, epilepsy, Parkinson's, or ALS.

I do not have uncorrectable hearing, vision problems, or learning disabilities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive targeted or active-control anodal-tDCS with speech therapy for 10 therapy sessions

10 weeks

10 visits (in-person)

Crossover Treatment

Participants crossover to receive the alternative tDCS intervention within the same speech therapy arm

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Active Control Transcranial Direct Current Stimulation
• Targeted Transcranial Direct Current Stimulation

Trial Overview The study tests if mild electrical stimulation (tDCS) combined with speech therapy can help improve language in people who've had a stroke causing aphasia. There are two types of tDCS being tested alongside two kinds of speech therapies focused on different aspects of language.

How Is the Trial Designed?

Group I: Targeted tDCS with Semantic-Focused Speech Therapy Experimental Treatment 2 Interventions

Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions.

Group II: Targeted tDCS with Phonologic-Focused Speech Therapy Experimental Treatment 2 Interventions

Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before.

Group III: Active Control tDCS with Phonologic-Focused Speech Therapy Active Control 2 Interventions

Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions.

Group IV: Active Control tDCS with Semantic-Focused Speech Therapy Active Control 2 Interventions

Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A systematic review of 21 trials involving 421 participants found no evidence that transcranial direct current stimulation (tDCS) improves functional communication in people with aphasia after stroke, indicating low effectiveness for this purpose.

However, there is moderate evidence that tDCS may enhance noun naming accuracy, suggesting it could have some benefits in specific language tasks, although it did not show similar effects for verb naming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for improving aphasia in adults with aphasia after stroke. Elsner, B., Kugler, J., Pohl, M., et al.[2023]

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]

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]

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) 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]

Citations

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

Effect of transcranial direct current stimulation combined ... tDCS combined with SLT demonstrates potential enhancement in language recovery on post-ischemic stroke aphasia. The combination may augment speech content, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319389/

Transcranial direct current stimulation to treat aphasia A number of studies have suggested that active transcranial direct current stimulation (A-tDCS) may improve treatment outcomes when coupled with behavioral ...

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

Effects of Transcranial Direct Current Stimulation (tDCS) on ... This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery.

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.041557

Transcranial Direct-Current Stimulation in Subacute Aphasia This single-center, randomized, double-blind, sham-controlled efficacy trial tested the hypothesis that anodal tDCS augments language therapy in subacute ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12550330/

Efficacy of cerebellar cathodal transcranial direct current ... Cerebellar cathodal tDCS combined with speech therapy improved language scores in post-stroke aphasia. fNIRS showed decreased right and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application. It is necessary to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12029044/

Remotely Supervised Transcranial Direct Current ... RS-tDCS is safe and feasible, affording beneficial effects in the motor, language, and cognitive functions of patients with post-stroke impairments.